Indication for Peripheral Intravenous CatheterisationNCT04344314

Impact of PIVC Length and Gauge on Catheter Indwell Time

A study testing Peripheral Intravenous Catheter in people with Indication for Peripheral Intravenous Catheterisation, run by Becton, Dickinson and Company at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Indication for Peripheral Intravenous Catheterisation
What is being tested?: Peripheral Intravenous Catheter
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteAustralia
Study dates: 31 Aug 2020to 12 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

Australia1 site

Griffith University
Gold Coast, Queensland, 4111

Other trials in Australia

About this study

Official title: 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

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.

Read the 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
Being tested: Peripheral Intravenous Catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peripheral Intravenous CatheterDevice
Randomised controlled

Study groups in NCT04344314
Study group	Role	What they receive
Small gauge arm	Other	2 PIVCs of same gauge (22G) and different lengths Receives: Device: Peripheral Intravenous Catheter
Large gauge arm	Other	2 PIVCs of same gauge (20G) and different lengths Receives: Device: Peripheral Intravenous Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Patent Indwell Time Between PIVCs of Different Length and Gauge.
Catheter indwell time for each PIVC, expressed in hours
Measured: 72 hrs

Secondary outcomes (1)

Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Haemolysis: Frequency of occurrence
Measured: 72 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202012 Mar 2021

First posted14 Apr 2020
Study start31 Aug 2020
Primary completion12 Mar 2021
Study completion12 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Indication for Peripheral Intravenous CatheterisationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised, controlled
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04344314
Sponsor's protocol ID: BDT-PIVCAU001
Status last verified: Jul 2023
First submitted: 7 Apr 2020
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04344314
Acronym / sponsor ID: BDT-PIVCAU001
Conditions: Indication for Peripheral Intravenous Catheterisation
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
Collaborators: Griffith University
Study start: 31 Aug 2020 (actual)
Primary completion: 12 Mar 2021 (actual)
Study completion: 12 Mar 2021 (actual)
First posted: 14 Apr 2020 (actual)
Results: Posted 16 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomised, controlled

Arm	Type	Receives
Small gauge arm	Other	Device: Peripheral Intravenous Catheter2 PIVCs of same gauge (22G) and different lengths
Large gauge arm	Other	Device: Peripheral Intravenous Catheter2 PIVCs of same gauge (20G) and different lengths

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (12 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peripheral Intravenous CatheterRandomised controlled	Device	Large gauge arm, Small gauge arm

Primary outcome

Patent Indwell Time Between PIVCs of Different Length and Gauge.
Time frame: 72 hrs
Catheter indwell time for each PIVC, expressed in hours

1 secondary outcome

Number of Participants With Haemolysis Occurrence Based on Blood Collection Device and Catheter Device Configuration
Time frame: 72 hrs

Results and safety

Results posted to the registry on 16 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PIVC 22G, 1 Inch Length	19	19
PIVC 22G, 1.75 Inch Length	19	19
PIVC 20G, 1 Inch Length	21	21
PIVC 20G, 1.75 Inch Length	21	21

Primary outcome: Patent Indwell Time Between PIVCs of Different Length and Gauge.

Time frame: 72 hrs. Mean (Standard Deviation). Unit: hours

Measure	PIVC 22G, 1 Inch Length n = 19	PIVC 22G, 1.75 Inch Length n = 19	PIVC 20G, 1 Inch Length n = 21	PIVC 20G, 1.75 Inch Length n = 21
Value	40.19 (25.34)	42.96 (22.04)	35.91 (25.55)	36.91 (21.36)

Population analysed: After screening and enrollment, participants will be randomized in order of their enrollment to either 20 or 22G of the BD NexivaTM PIVC and order of placement location (left or right arm first). The participant will have both the 1 inch and 1.75 inch PIVCs inserted on Study Day 1 (Visit 2), one into each arm. After successful insertion into the lower cephalic vein of the selected arm, the site will be regularly accessed (twice daily) for phlebotomy and then flushed.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events are collected from time of enrollment until catheter removal (max 72 hours indwell time). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PIVC 22G, 1 Inch Length	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
PIVC 22G, 1.75 Inch Length	0 of 21 (0%)	1 of 19 (5.3%)	0 of 19
PIVC 20G, 1 Inch Length	0 of 21 (0%)	11 of 21 (52.4%)	0 of 21
PIVC 20G, 1.75 Inch Length	0 of 21 (0%)	8 of 21 (38.1%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral Intravenous Catheter in people with Indication for Peripheral Intravenous Catheterisation, run by Becton, Dickinson and Company at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patent Indwell Time Between PIVCs of Different Length and Gauge. (time frame: 72 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04344314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.