Impact of PIVC Length and Gauge on Catheter Indwell Time

NCT ID: NCT04344314

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2021-03-12

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.

Conditions

Indication for Peripheral Intravenous Catheterisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Small gauge arm

2 PIVCs of same gauge (22G) and different lengths

Group Type: OTHER

Peripheral Intravenous Catheter

Intervention Type: DEVICE

Randomised controlled

Large gauge arm

2 PIVCs of same gauge (20G) and different lengths

Group Type: OTHER

Peripheral Intravenous Catheter

Intervention Type: DEVICE

Randomised controlled

Interventions

Peripheral Intravenous Catheter

Randomised controlled

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Griffith University

OTHER

Sponsor Role: collaborator

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Griffith University

Gold Coast, Queensland, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BDT-PIVCAU001

Identifier Type: -

Identifier Source: org_study_id