Status:
COMPLETED
Impact of PIVC Length and Gauge on Catheter Indwell Time
Lead Sponsor:
Becton, Dickinson and Company
Collaborating Sponsors:
Griffith University
Conditions:
Indication for Peripheral Intravenous Catheterisation
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04344314
Start Date
August 31 2020
End Date
March 12 2021
Last Update
May 16 2024
Active Locations (1)
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1
Griffith University
Gold Coast, Queensland, Australia, 4111