Dehydration
Conditions
Keywords
dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20
Brief summary
The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.
Interventions
DRUGSubcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution
Sponsors
Halozyme Therapeutics
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 18 to 60 years, inclusive. * Body mass index 19.0 to 35.0 kg/m2 * Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion * Free from any clinically significant abnormality on the basis of medical/medication history or physical examination * Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant * Negative urine drug and alcohol screens.
Exclusion criteria
* Upper back pathology that could interfere with study outcome. * History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency. * Rales on lung auscultation. * Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant * Treatment with furosemide, benzodiazepines, or phenytoin. * Pregnancy or breastfeeding. * Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study. * Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Measured In-line Fluid Pressure | each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion | Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | end of catheter/needle placement | — |
| Cumulative Fluid Volume Delivered | each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion | — |
| Technical Challenges Encountered During Fluid Infusion | at any occurence of a defined challenge or at end of infusion if no challenges occurred | Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | 2 |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | 3 |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | 3 |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | 3 |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | 2 |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | 2 |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | 2 |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | 3 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | 24 ga Catheter, Dose Flush, Single-step Rate Scheme | 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | 25 ga Needle, Dose Flush, Single-step Rate Scheme | 25 ga Needle, No Dose Flush, Single-step Rate Scheme | 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants |
| Age Continuous | 33.3 years | 45.9 years | 32.6 years | 39.6 years | 29.3 years | 35.4 years | 39.7 years | 28.2 years | 20.9 years |
| Region of Enrollment United States | 20 participants | 2 participants | 3 participants | 3 participants | 3 participants | 2 participants | 2 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 12 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 3 / 3 | 3 / 3 | 3 / 3 | 2 / 2 | 2 / 2 | 2 / 2 | 3 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 3 |
Outcome results
Primary
Maximum Measured In-line Fluid Pressure
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion
Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Population: Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 6.5 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 3.3 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 6.7 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 7.0 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 3.1 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 7.3 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 4.1 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 4.6 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 3.4 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 6.4 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 3.8 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 6.5 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 5.3 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 6.5 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 6.7 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 5.3 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 6.1 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 6.6 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 3.1 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 6.2 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 6.8 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 6.7 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 6.8 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 7.3 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 3.1 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 5.8 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 3.6 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 4.0 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 6.6 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 6.2 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 6.6 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 3.4 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 6.5 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 3.2 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 6.4 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 5.0 psi |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 6.9 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 2.4 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 2.4 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 4.0 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 3.0 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 4.4 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 4.9 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 2.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 4.0 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 2.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 3.0 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 2.7 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 2.3 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 3.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 2.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 4.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 2.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 2.4 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 3.7 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 3.1 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 3.9 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 2.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 3.8 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 3.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 2.7 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 3.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 2.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 3.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 2.2 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 3.3 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 2.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 7.8 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 2.1 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 2.6 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 4.0 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 2.1 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 4.0 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 2.1 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 4.3 psi |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 3.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 7.7 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 1.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 3.4 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 9.1 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 8.8 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 7.4 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 2.1 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 3.5 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 2.0 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 8.5 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 2.1 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 9.0 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 2.6 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 2.5 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 2.2 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 11.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 8.4 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 8.8 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 8.0 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 7.3 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 2.2 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 7.8 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 2.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 1.9 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 2.6 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 7.7 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 6.8 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 3.0 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 13.6 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 3.0 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 2.3 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 2.5 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 3.3 psi |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 8.2 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 7.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 5.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 10.3 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 4.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 7.3 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 10.9 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 4.8 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 4.5 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 15.8 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 11.5 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 7.1 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 10.5 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 6.1 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 5.2 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 8.6 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 7.4 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 5.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 5.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 7.1 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 17.7 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 5.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 4.9 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 5.7 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 4.4 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 4.8 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 4.8 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 8.7 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 6.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 5.0 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 5.9 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 5.2 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 7.6 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 7.9 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 7.4 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 6.2 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 7.8 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 7.7 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 11.9 psi |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 5.9 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 4.3 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 3.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 4.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 4.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 4.5 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 4.5 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 4.4 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 3.7 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 3.6 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 3.5 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 4.0 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 4.3 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 3.7 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 4.6 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 3.3 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 3.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 3.9 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 3.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 3.4 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 3.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 3.5 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 2.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 3.8 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 4.2 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 4.3 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 4.4 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 4.6 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 4.2 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 4.2 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 4.1 psi |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 4.1 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 2.8 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 3.3 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 2.4 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 2.9 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 2.6 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 2.6 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 2.5 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 2.7 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 3.3 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 3.1 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 2.7 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 2.6 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 2.8 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 2.7 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 2.7 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 2.6 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 3.3 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 2.5 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 2.6 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 2.8 psi |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 3.2 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 3.4 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 4.0 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 3.4 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 3.8 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 3.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 4.2 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 1.1 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 3.8 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 2.5 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 3.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 2.5 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 1.1 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 3.9 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 2.2 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 2.9 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 3.7 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 2.8 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 3.7 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 2.1 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 1.2 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 2.7 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 2.1 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 2.2 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 1.1 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 3.4 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 1.0 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 2.2 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 3.4 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 2.6 psi |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 3.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 14 min | 6.9 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 1 min | 3.0 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 225 min | 3.3 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 2 min | 2.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 210 min | 6.3 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 135 min | 7.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 3 min | 2.5 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 195 min | 3.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 180 min | 3.2 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 4 min | 2.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 165 min | 3.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 5 min | 2.5 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 150 min | 7.0 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 6 min | 2.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 120 min | 6.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 105 min | 6.3 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 7 min | 3.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 90 min | 7.5 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 15 min | 6.5 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 8 min | 4.6 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 75 min | 7.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 9 min | 4.1 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 60 min | 6.5 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 55 min | 6.0 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 40 min | 5.9 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 10 min | 3.9 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 50 min | 5.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 11 min | 6.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 45 min | 5.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 12 min | 7.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 35 min | 6.4 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 30 min | 5.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 20 min | 6.2 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 25 min | 6.1 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 270 min | 4.8 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 285 min | 4.3 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 13 min | 7.0 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 255 min | 4.9 psi |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Maximum Measured In-line Fluid Pressure | 240 min | 5.3 psi |
Secondary
Cumulative Fluid Volume Delivered
Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Population: Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 250 mL |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 848 mL |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 41.2 mL |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 998 mL |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 649 mL |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 20.8 mL |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 448 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 41.3 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 850 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 450 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 650 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 1000 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 21.4 mL |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 249 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 4.2 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 649 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 849 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 999 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 449 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 11.7 mL |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 249 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 447 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 3.8 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 997 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 11.5 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 848 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 240 mL |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 647 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 449 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 21.1 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 42.0 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 249 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 649 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 849 mL |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 999 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 447 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 997 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 647 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 249 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 847 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 41.2 mL |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 20.7 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 12.1 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 4.1 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 847 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 650 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 997 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 248 mL |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 448 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 285 min | 996 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 120 min | 446 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 240 min | 846 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 5 min | 4.1 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 60 min | 246 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 180 min | 646 mL |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Cumulative Fluid Volume Delivered | 10 min | 11.9 mL |
Secondary
Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
Time frame: end of catheter/needle placement
Population: Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 2 Subjects |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 3 Subjects |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 2 Subjects |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 1 Subjects |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 2 Subjects |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 2 Subjects |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 1 Subjects |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 2 Subjects |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 2 attempts | 0 Subjects |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement | 1 attempt | 3 Subjects |
Secondary
Technical Challenges Encountered During Fluid Infusion
Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems
Time frame: at any occurence of a defined challenge or at end of infusion if no challenges occurred
Population: Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 24 ga Catheter, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |
| 24 ga Catheter, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 24 ga Catheter, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 2 participants |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 1 participants |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 2 participants |
| 24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 1 participants |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 25 ga Needle, Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 25 ga Needle, No Dose Flush, Single-step Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 25 ga Needle, Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Catheter Kinking | 0 participants |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Occlusion Alarm | 0 participants |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Intervention Needed to Secure/Maintain Infusion | 0 participants |
| 25 ga Needle, No Dose Flush, Up-titrated Rate Scheme | Technical Challenges Encountered During Fluid Infusion | Any Technical Challenge | 0 participants |