Indication for Peripheral Intravenous Catheterisation Clinical Trial
Official title:
A Randomized Controlled Post-market Study to Assess the Impact of Peripheral Intravenous Catheter Length and Gauge on Catheter Indwell Duration and Haemolysis in Human Participants Using a Bilateral, Cephalic Vein Cannulation Model
| Verified date | July 2023 |
| Source | Becton, Dickinson and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 12, 2021 |
| Est. primary completion date | March 12, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Griffith University | Gold Coast | Queensland |
| Lead Sponsor | Collaborator |
|---|---|
| Becton, Dickinson and Company | Griffith University |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patent Indwell Time Between PIVCs of Different Length and Gauge. | Catheter indwell time for each PIVC, expressed in hours | 72 hrs | |
| Secondary | Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration | Haemolysis: Frequency of occurrence | 72 hrs |