Vascular Access Complication
Conditions
Keywords
IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter Study, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Complication Rates for IV Catheters, Average Dwell Time for IV Catheters, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance
Brief summary
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters.
Detailed description
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.
Interventions
DEVICEAccuCath IV Catheter Device
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
DEVICEConventional IV Catheter Device
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, age ≥ 18 years or ≤ 89 years old; 2. Capable and willing to give informed consent; 3. English speaking; 4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician; 5. Admitted to study inpatient unit.
Exclusion criteria
1. Male or female, \< 18 years old or \> 89 years old; 2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement); 3. Previous venous grafts or surgery at the target vessel access site; 4. Currently involved in other investigational clinical trials (unless permission is granted by other study principal investigator \[PI\]); 5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Attempt Success Rate With Peripheral IV Catheter Placement | At catheter placement, an expected average of 10 minutes | The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of Peripheral IV Therapy | From during to post IV catheter placement up to study exit (~ up to 7 days) | Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (\ up to 7 days). |
| Catheter Dwell Time | Study Exit/At catheter removal (~ up to 7 days) | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) \ up to 7 days. |
| Patient Satisfaction At Insertion | At catheter insertion, initial 3-15 minutes after insertion procedure completed. | Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. |
| Completion of IV Therapy | Study exit/At catheter removal (~ up to 7 days) | Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (\ up to 7 days). |
| Adverse Events | During and post IV catheter placement until study exit (maximum of 6 months). | Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time. |
| Patient Satisfaction Comfort Comparison | Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure. | Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. |
| Patient Satisfaction With Overall IV Performance | At IV removal (usually after 1-7 days of IV dwell time) | Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. |
| Clinician Satisfaction | At completion of study after all patients have been enrolled (approximately 6 months from study initiation) | Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AccuCath IV Catheter Device AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal
AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. | 123 |
| Conventional IV Catheter Device Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.
Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. | 125 |
| Total | 248 |
Baseline characteristics
| Characteristic | AccuCath IV Catheter Device | Conventional IV Catheter Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 65 Participants | 56 Participants | 121 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 69 Participants | 127 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 15.5 | 62.2 years STANDARD_DEVIATION 14.5 | 62.5 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 123 Participants | 246 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 54 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 73 Participants | 67 Participants | 140 Participants |
| Region of Enrollment United States | 123 participants | 125 participants | 248 participants |
| Sex: Female, Male Female | 49 Participants | 69 Participants | 118 Participants |
| Sex: Female, Male Male | 74 Participants | 56 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 123 | 65 / 125 |
| serious Total, serious adverse events | 0 / 123 | 0 / 125 |
Outcome results
Primary
First Attempt Success Rate With Peripheral IV Catheter Placement
The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.
Time frame: At catheter placement, an expected average of 10 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath IV Catheter Device | First Attempt Success Rate With Peripheral IV Catheter Placement | 89 percentage of participants |
| Conventional IV Catheter Device | First Attempt Success Rate With Peripheral IV Catheter Placement | 47 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Adverse Events
Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.
Time frame: During and post IV catheter placement until study exit (maximum of 6 months).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AccuCath IV Catheter Device | Adverse Events | Phlebitis | 0.8 percentage of participants |
| AccuCath IV Catheter Device | Adverse Events | Occlusion | 1.6 percentage of participants |
| AccuCath IV Catheter Device | Adverse Events | Leaking | 0.8 percentage of participants |
| AccuCath IV Catheter Device | Adverse Events | Dislodgement | 2.4 percentage of participants |
| AccuCath IV Catheter Device | Adverse Events | Infiltration | 2.4 percentage of participants |
| Conventional IV Catheter Device | Adverse Events | Dislodgement | 4.8 percentage of participants |
| Conventional IV Catheter Device | Adverse Events | Infiltration | 26.4 percentage of participants |
| Conventional IV Catheter Device | Adverse Events | Phlebitis | 8.8 percentage of participants |
| Conventional IV Catheter Device | Adverse Events | Leaking | 5.6 percentage of participants |
| Conventional IV Catheter Device | Adverse Events | Occlusion | 5.6 percentage of participants |
Secondary
Catheter Dwell Time
Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) \ up to 7 days.
Time frame: Study Exit/At catheter removal (~ up to 7 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AccuCath IV Catheter Device | Catheter Dwell Time | 105 hours | Standard Deviation 61 |
| Conventional IV Catheter Device | Catheter Dwell Time | 35 hours | Standard Deviation 25 |
p-value: <0.0001t-test, 2 sided
Secondary
Clinician Satisfaction
Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AccuCath IV Catheter Device | Clinician Satisfaction | 4 units on a scale |
Secondary
Completion of IV Therapy
Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (\ up to 7 days).
Time frame: Study exit/At catheter removal (~ up to 7 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath IV Catheter Device | Completion of IV Therapy | 89.4 percentage of participants |
| Conventional IV Catheter Device | Completion of IV Therapy | 34.4 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Complications of Peripheral IV Therapy
Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (\ up to 7 days).
Time frame: From during to post IV catheter placement up to study exit (~ up to 7 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AccuCath IV Catheter Device | Complications of Peripheral IV Therapy | 8 percentage of participants |
| Conventional IV Catheter Device | Complications of Peripheral IV Therapy | 52 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Patient Satisfaction At Insertion
Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: At catheter insertion, initial 3-15 minutes after insertion procedure completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AccuCath IV Catheter Device | Patient Satisfaction At Insertion | 4.6 units on a scale | Standard Deviation 0.69 |
| Conventional IV Catheter Device | Patient Satisfaction At Insertion | 3.0 units on a scale | Standard Deviation 1.27 |
p-value: <0.0001t-test, 2 sided
Secondary
Patient Satisfaction Comfort Comparison
Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AccuCath IV Catheter Device | Patient Satisfaction Comfort Comparison | 4.2 units on a scale | Standard Deviation 1.02 |
| Conventional IV Catheter Device | Patient Satisfaction Comfort Comparison | 2.86 units on a scale | Standard Deviation 1.18 |
p-value: <0.0001t-test, 2 sided
Secondary
Patient Satisfaction With Overall IV Performance
Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: At IV removal (usually after 1-7 days of IV dwell time)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AccuCath IV Catheter Device | Patient Satisfaction With Overall IV Performance | 4.84 units on a scale | Standard Deviation 0.41 |
| Conventional IV Catheter Device | Patient Satisfaction With Overall IV Performance | 2.84 units on a scale | Standard Deviation 1.01 |
p-value: <0.0001t-test, 2 sided