Impact of PIVC Length and Gauge on Catheter Indwell Time

May 8, 2024 updated by: Becton, Dickinson and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Small gauge arm
2 PIVCs of same gauge (22G) and different lengths
Device: Peripheral Intravenous Catheter
Randomised controlled
Other: Large gauge arm
2 PIVCs of same gauge (20G) and different lengths
Device: Peripheral Intravenous Catheter
Randomised controlled

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patent Indwell Time Between PIVCs of Different Length and Gauge.
Time Frame: 72 hrs
Catheter indwell time for each PIVC, expressed in hours
72 hrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Time Frame: 72 hrs
Haemolysis: Frequency of occurrence
72 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Becton, Dickinson and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Griffith University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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