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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
Randomised controlled
Griffith University
Gold Coast, Queensland, Australia
Patent Indwell Time Between PIVCs of Different Length and Gauge.
Catheter indwell time for each PIVC, expressed in hours
Time frame: 72 hrs
Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Haemolysis: Frequency of occurrence
Time frame: 72 hrs
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