Impact of PIVC Length and Gauge on Catheter Indwell Time

NCT04344314 | Completed Results FDA Device

• 1 other identifier: BDT-PIVCAU001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Indication for Peripheral Intravenous Catheterisation

Outcome Measures

Primary Outcomes (1)

• Patent Indwell Time Between PIVCs of Different Length and Gauge.

  Catheter indwell time for each PIVC, expressed in hours

  72 hrs

Secondary Outcomes (1)

• Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration

  72 hrs

Study Arms (2)

Small gauge arm

OTHER

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

Device: Peripheral Intravenous Catheter

Large gauge arm

OTHER

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

Device: Peripheral Intravenous Catheter

Interventions

Peripheral Intravenous Catheter DEVICE

Randomised controlled

Large gauge arm; Small gauge arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or Male
• 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

You may not qualify if:

• History of pro coagulative state/condition (e.g. previous deep vein thrombosis
• Current hypertension (e.g., systolic \>139 OR diastolic \>89 mmHg)
• 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)

Sponsors & Collaborators

• Becton, Dickinson and Company: lead
• Griffith University: collaborator

Study Sites (1)

Griffith University

Gold Coast, Queensland, 4111, Australia

Location

Results Point of Contact

• Title: Christopher Rini, Associate Director Translational and Clinical Sciences Center of Excellence
• Organization: Becton, Dickinson and Company

christopher.rini@bd.com

+1 984 389 1186

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, controlled

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 14, 2020
• Study Start: August 31, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)