Impact of PIVC Length and Gauge on Catheter Indwell Time

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

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.

Study Overview

• Status: Completed
• Conditions: Indication for Peripheral Intravenous Catheterisation
• Intervention / Treatment: Device: Peripheral Intravenous Catheter

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 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Gold Coast, Queensland, Australia, 4111
      • Griffith University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 ADP, 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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Small gauge arm; 2 PIVCs of same gauge and different lengths	Device: Peripheral Intravenous Catheter; Randomised controlled
OTHER: Large gauge arm; 2 PIVCs of same gauge and different lengths	Device: Peripheral Intravenous Catheter; Randomised controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess patent indwell time between PIVCs of different length and gauge.	Catheter indwell time for each PIVC	72 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess haemolysis occurrence based on blood collection device, catheter device configuration	Haemolysis: Frequency of occurrence	72 hrs

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Collaborators: Griffith University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): March 12, 2021
• Study Completion (ACTUAL): March 12, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (ACTUAL): April 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BDT-PIVCAU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes