Indication for Peripheral Intravenous Catheterisation
Conditions
Brief summary
This is a single-centre, open-label, multi-visit study design, in 40 healthy participants, randomized by gauge of peripheral intravenous catheter (PIVC) device into the lower arm cephalic vein of both arms. The purpose of this study is to assess impact of catheter length and gauge on PIVC indwell time over a 72 hour period. This study will also evaluate the incidence of haemolysis using blood draws from the PIVC.
Detailed description
The study aims to provide preliminary information on the performance of the peripheral intravenous catheter (PIVC) device, * assess how blood collection through different catheters over time effects device performance, and * assess the quality of the blood that is collected through those catheters. Four variations of the Becton Dickinson (BD) Nexiva PIVC will be used in this study. Participants will be randomised by gauge of peripheral intravenous catheter (PIVC) device into the lower arm cephalic vein of both arms. PIVC indwell time will be monitored up to 72 hrs (removal at 72 hrs or upon inability to flush/aspirate). Blood will be collected Day 1 throughout the remainder of indwell time. Each participant will complete 6 visits: a Screening Visit (V1), PIVC in situ (V2-V5) and follow-up (V6). The in-situ catheter positions will be compared to the expected tip position based on the catheter lengths. Blood collected will be analysed for haemolysis. As both device length and gauge are expected to influence haemolysis the study design enables evaluation of both design features.
Interventions
Randomised controlled
Sponsors
Griffith University
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomised, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female or Male * 18-65 years of age * Not pregnant at time of recruitment within 48 hrs Day 1 procedures (self-reported) * Normal coagulation results (prothrombin time 13-17 sec; activated partial thromboplastin time 27-37 sec) * Normal platelet aggregation results for Adenosine DiPhosphate (ADP), Thrombin Receptor Activating Peptide (TRAP), and collagen induced maximal amplitude (\>70% amplitude over 6 mins) * Target cephalic veins readily cannulatable (i.e., ≥ \ 2.55 mm to obtain C/V ratio less than 45% as indicated by standard 52 of the Intraevenous Nursing Standards (INS) guidelines * Able and willing to provide verbal and written consent * Must be an Australian citizen with current Medicare card
Exclusion criteria
* History of pro coagulative state/condition (e.g. previous deep vein thrombosis * Current hypertension (e.g., systolic \>139 OR diastolic \>89 mmHg) * Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and aspirin will be documented however not exclusionary. * Hemophilia or any current or history of bleeding disorder or tendency * Presence or report of current blood borne disease/infection (e.g. hepatitis, HIV, leukemia, lymphoma) * Difficult vascular access (i.e., vein must be readily palpable and cannulatable - no less than \ 2.55 mm diameter to maintain ≤45% C/V ratio) as indicated by standard 52 of the INS guidelines * Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin adhesives * BMI \<18.5 kg/m2 or ≥35 kg/m2 * Positive results for the urine drug screen at screening or check-in (including opiates, methadone, cocaine, amphetamines) * History or presence of alcoholism (self-reported) or drug abuse within the past 2 years * A current or previous medical, physical, mental/cognitive disorders or anatomical conditions that, in the opinion of the investigator, would place the patient at risk, would make them unable to perform study procedures or has the potential to confound interpretation of the study results. (e.g., musculo-skeletal injury, chronic back pain) * Employed by Becton Dickinson, Teleflex Medical, Smiths Medical or B Braun (conflict of interest)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patent Indwell Time Between PIVCs of Different Length and Gauge. | 72 hrs | Catheter indwell time for each PIVC, expressed in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | 72 hrs | Haemolysis: Frequency of occurrence |
Countries
Australia
Participant flow
Recruitment details
40 enrolled and randomized subjects
Participants by arm
| Arm | Count |
|---|---|
| Small Gauge 2 PIVCs of same gauge (22G) and different lengths
Peripheral Intravenous Catheter: Randomised controlled | 19 |
| Large Gauge 2 PIVCs of same gauge (20G) and different lengths
Peripheral Intravenous Catheter: Randomised controlled | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Small Gauge | Large Gauge | Total |
|---|---|---|---|
| Age, Continuous | 27.58 years STANDARD_DEVIATION 8.82 | 32.76 years STANDARD_DEVIATION 13.12 | 30.3 years STANDARD_DEVIATION 11.45 |
| BMI | 25.09 kg/m^2 STANDARD_DEVIATION 3.65 | 26.84 kg/m^2 STANDARD_DEVIATION 5.22 | 26.01 kg/m^2 STANDARD_DEVIATION 4.57 |
| Diastolic Blood Pressure | 76.42 mm Hg STANDARD_DEVIATION 8.09 | 76.71 mm Hg STANDARD_DEVIATION 7.4 | 76.58 mm Hg STANDARD_DEVIATION 7.46 |
| O2 saturation | 97.89 Percentage of oxygen in blood STANDARD_DEVIATION 1.05 | 97.71 Percentage of oxygen in blood STANDARD_DEVIATION 1.23 | 97.80 Percentage of oxygen in blood STANDARD_DEVIATION 1.14 |
| Race/Ethnicity, Customized Asian | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian, White | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 12 Participants | 23 Participants |
| Recent use of analgesics No recent use of analgetic | 13 Participants | 19 Participants | 32 Participants |
| Recent use of analgesics Recent use of analgetic | 6 Participants | 2 Participants | 8 Participants |
| Region of Enrollment Australia | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
| Systolic Blood Pressure | 115.83 mm Hg STANDARD_DEVIATION 10.75 | 117.90 mm Hg STANDARD_DEVIATION 10.02 | 116.92 mm Hg STANDARD_DEVIATION 10.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 1 / 19 | 1 / 19 | 11 / 21 | 8 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 | 0 / 21 | 0 / 21 |
Outcome results
Primary
Patent Indwell Time Between PIVCs of Different Length and Gauge.
Catheter indwell time for each PIVC, expressed in hours
Time frame: 72 hrs
Population: After screening and enrollment, participants will be randomized in order of their enrollment to either 20 or 22G of the BD NexivaTM PIVC and order of placement location (left or right arm first). The participant will have both the 1 inch and 1.75 inch PIVCs inserted on Study Day 1 (Visit 2), one into each arm. After successful insertion into the lower cephalic vein of the selected arm, the site will be regularly accessed (twice daily) for phlebotomy and then flushed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PIVC 22G, 1 Inch Length | Patent Indwell Time Between PIVCs of Different Length and Gauge. | 40.19 hours | Standard Deviation 25.34 |
| PIVC 22G, 1.75 Inch Length | Patent Indwell Time Between PIVCs of Different Length and Gauge. | 42.96 hours | Standard Deviation 22.04 |
| PIVC 20G, 1 Inch Length | Patent Indwell Time Between PIVCs of Different Length and Gauge. | 35.91 hours | Standard Deviation 25.55 |
| PIVC 20G, 1.75 Inch Length | Patent Indwell Time Between PIVCs of Different Length and Gauge. | 36.91 hours | Standard Deviation 21.36 |
Secondary
Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Haemolysis: Frequency of occurrence
Time frame: 72 hrs
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| PIVC 22G, 1 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 2 mL collection tube | 0 arms |
| PIVC 22G, 1 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 6 mL collection tube | 0 arms |
| PIVC 22G, 1.75 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 6 mL collection tube | 0 arms |
| PIVC 22G, 1.75 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 2 mL collection tube | 0 arms |
| PIVC 20G, 1 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 2 mL collection tube | 0 arms |
| PIVC 20G, 1 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 6 mL collection tube | 0 arms |
| PIVC 20G, 1.75 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 2 mL collection tube | 0 arms |
| PIVC 20G, 1.75 Inch Length | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Visual haemolysis, 6 mL collection tube | 0 arms |