NCT04344314

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Indication for Peripheral Intravenous Catheterisation

Interventions

Type	Name	Description
DEVICE	Peripheral Intravenous Catheter	Randomised controlled

Timeline

• Start date: 2020-08-31
• Primary completion: 2021-03-12
• Completion: 2021-03-12
• First posted: 2020-04-14
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study