Clinical trial NCT04344314: Impact of PIVC Length and Gauge on Catheter Indwell Time
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indication for Peripheral Intravenous Catheterisation
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
Collaborators: name: Griffith University
First posted: 2020-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patent Indwell Time Between PIVCs of Different Length and Gauge.
timeFrame: 72 hrs
Secondary outcomes:
measure: Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
timeFrame: 72 hrs
Other outcomes:
Locations:
city: Gold Coast
country: Australia
facility: Griffith University
state: Queensland
Study officials:
References: