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Trial registered on ANZCTR


Registration number
ACTRN12619001091190
Ethics application status
Approved
Date submitted
24/07/2019
Date registered
8/08/2019
Date last updated
2/03/2021
Date data sharing statement initially provided
8/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Controlling device Occlusion by needleless ConnectOr design. A pilot randomised control trial (COCOA Trial)
Scientific title
A pilot randomised controlled trial to compare incidence of peripheral venous catheter failure with the use of neutral versus negative needleless connectors (COCOA Trial)
Secondary ID [1] 298639 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
COCOA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failure 313519 0
Condition category
Condition code
Public Health 311956 311956 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will have peripheral venous catheters (PVC) inserted in an adult tertiary hospital. Consenting patients will have their PVC connected to one of the following to randomly assigned needleless connectors:
Arm 1 (Intervention): MicroClave (neutral pressure) needleless connector, attached prior to the first device access.
Arm 2 (Control): Smartsite (negative pressure) needleless connector, attached prior to the first device access.
Patients will be monitored daily to ensure protocol adherence and assess for any complications. The randomly allocated connector will be applied from device insertion (by the inserter - either a Research Nurse or treating clinician) and replaced as clinically indicated (by treating clinicians) until removal of device.
PVC insertion site (eg. hand, forearm) will be selected by the Research Nurse or treating clinician based on site and vein appropriateness.
Duration of treatment (PVC dwell) will be between 1-29 days (approximately).
Intervention code [1] 314902 0
Treatment: Devices
Comparator / control treatment
Application of a SmartSite (negative pressure) needleless connector to the Peripheral Venous Catheter (prior to the first device access).

In both groups, standard hospital policies will be followed skin decontamination prior to insertion, use of sterile transparent dressings and securement, and needleless connector attachments (eg. extension tubing).
Control group
Active

Outcomes
Primary outcome [1] 320612 0
The feasibility of conducting an adequately powered RCT as established by the following criteria:
• Eligibility (equal to or more than 90% of screened patients will be eligible),
• Recruitment (equal to or more than 90% of eligible patients will consent to trial participation),
• Retention and attrition (equal to or less than 5% of participants will be lost to follow up including those who withdraw consent),
• Protocol adherence (equal to or more than 90% of randomised participants receive their randomised intervention),
• Missing data (equal to or less than 5% data will be missing),
• Effect size (this will inform future sample size calculations),
• Patient satisfaction (of PVC at insertion and removal, scored 0 (dissatisfied) to 10 (completely satisfied)).
Timepoint [1] 320612 0
On device removal (eg. patient satisfaction) or at the time of trial completion (eg. missing data), as appropriate.
Primary outcome [2] 320613 0
All-cause device failure. This is defined as premature device removal before the end of therapy because of: phlebitis; infiltration/extravasation; occlusion (including leakage); local or catheter related bloodstream infection.

These will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [2] 320613 0
Daily from device insertion until device removal.
Infection outcomes will be assessed from the time of device insertion to 48 hours after device removal.
Secondary outcome [1] 372194 0
Phlebitis: defined as pain/tenderness alone (>2); or two or more signs/symptoms of: pain (0-10); tenderness (0-10); erythema, swelling, or palpable cord (any, recorded in cm); or purulent discharge (any).

This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [1] 372194 0
Daily from device insertion until device removal.
Infection outcomes will be assessed from the time of device insertion to 48 hours after device removal.
Secondary outcome [2] 372195 0
PVC dislodgment (partial) or accidental removal (completely leaves vein).

This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [2] 372195 0
Daily from device insertion until the time of device removal.
Secondary outcome [3] 372196 0
PVC dwell time: from the time of PVC insertion until removal from either device failure, routine replacement or the completion of IV therapy.

This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [3] 372196 0
Daily from device insertion until the time of device removal.
Secondary outcome [4] 372197 0
Cost effectiveness: estimates of costs of staff resources, equipment and PVC failure resource usage with previously developed cost estimations.

Equipment resources (volume) (eg. needleless connector use) will assessed by either the Research Nurse (upon insertion and during daily checks); staff resources (eg. time to insert PVC) will be estimated and extrapolated from published literature in a similar population with PVC.
Timepoint [4] 372197 0
Daily from device insertion until the time of device removal.
Secondary outcome [5] 373319 0
Infiltration (the movement of IV fluids into the surrounding tissue); with or without extravasation (ie. infiltration resulting in damage to surrounding tissue).

This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [5] 373319 0
Daily from device insertion until the time of device removal.
Secondary outcome [6] 373320 0
Occlusion (the PVC will not flush or leaks when flushed)

This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [6] 373320 0
Daily from device insertion until the time of device removal.
Secondary outcome [7] 373321 0
Local infection (collected as per current clinical treatment); defined as per the National Health and Safety Network (BSI-LCBI) criteria.

This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record (including microbiology results).

Collection of microbiological specimens (eg. skin swabs, tips) will be as per the patient's treating team (not the Research Team).
Timepoint [7] 373321 0
From the time of device insertion to 48 hours after device removal.
Secondary outcome [8] 373323 0
CRBSI (collected as per current clinical treatment); defined as per the National Health and Safety Network (BSI-LCBI) criteria.


This will be assessed by either the Research Nurse (during daily checks and upon PVC removal); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record (including microbiology results).

Collection of microbiological specimens (eg. blood, skin swabs, tips) will be as per the patient's treating team (not the Research Team).
Timepoint [8] 373323 0
From the time of device insertion to 48 hours after device removal.

Eligibility
Key inclusion criteria
1. Patient requires a PVC for greater than 24 hours
2. PVC has not been insitu greater than 2 hours
3. The PVC has not yet been accessed for treatment
4. Equal to or more than 18 years of age (no upper limit)
5. Able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current blood stream infection (within 48 hours of study entry, with the exclusion of a single common skin contaminant as per NHSN)
• Non-English speaker without interpreter
• Previous enrolment in this study
• On a palliative care pathway and/or receiving critical care treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is fully concealed until the patient is randomised (computer generated allocation is provided by an independent web-based randomisation service).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. Randomisation will be in a 1:1 ratio, in varying block sizes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility outcomes will be reported descriptively and analysed against pre-determined acceptability criteria, e.g. missing data. As a pilot study, statistical comparison methods will be used for piloting purposes only. Descriptive statistics will be used to describe the sample. Mean values and standard deviations (SD) will be reported for normally distributed data; median values and 25th/75th percentiles reported otherwise. Cox regression will be used to assess the effect of patients and treatment differences as well as for group comparisons. A graph of the Kaplan-Meier survival function will be generated, and the proportional hazards assumption checked with the log-log plot of survival, and log-rank test performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2019
Actual
3/03/2020
Date of last participant enrolment
Anticipated
31/07/2020
Actual
1/09/2020
Date of last data collection
Anticipated
1/05/2020
Actual
6/09/2020
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14133 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 26945 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 303179 0
University
Name [1] 303179 0
Griffith University
Country [1] 303179 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 303405 0
Hospital
Name [1] 303405 0
Royal Brisbane and Women's Hospital
Address [1] 303405 0
Level 2, Building 34
Cnr Bowen Bridge Rd and Butterfield St
Herston, QLD 4029
Country [1] 303405 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303742 0
Royal Brisbane and Women's Hospital, Human Research Ethtics Committee
Ethics committee address [1] 303742 0
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Rd & Butterfield St
Herston
QLD, 4029
Ethics committee country [1] 303742 0
Australia
Date submitted for ethics approval [1] 303742 0
24/11/2018
Approval date [1] 303742 0
20/12/2018
Ethics approval number [1] 303742 0
HREC/2018/QRBW/48811
Ethics committee name [2] 305790 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 305790 0
Office for Research
Bray Centre, Nathan Campus
Griffith University
170 Kessels Rd,
Nathan, 4111
Queensland
Ethics committee country [2] 305790 0
Australia
Date submitted for ethics approval [2] 305790 0
16/07/2019
Approval date [2] 305790 0
24/07/2019
Ethics approval number [2] 305790 0
2019/573

Summary
Brief summary
Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access device to provide intravenous treatment to hospitalised patients. A needleless connector (NC) allows a PVC to be connected to an administration set or syringe without the use of needles. Many hospitals (including the Royal Brisbane and Women’s Hospital) use a negative pressure NC. This device, on the completion of access or flushing, creates a negative displacement allowing a small amount of blood to move back into the catheter. Manufacturers have recently created complex NCs comprised of mechanical valves with neutral pressure (no fluid displacement). This randomised controlled trial will test the efficacy, cost effectiveness and acceptability to patients of a neutral pressure NC.
Sample: 200 adult patients in the cancer care, general medical and surgical wards of the RBWH. Primary outcomes: (1) feasibility (2) device failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94638 0
Dr Nicole Marsh
Address 94638 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield Street
Herston, Qld, 4029
Country 94638 0
Australia
Phone 94638 0
+61 736468740
Fax 94638 0
Email 94638 0
[email protected]
Contact person for public queries
Name 94639 0
Nicole Marsh
Address 94639 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield Street
Herston, Qld, 4029
Country 94639 0
Australia
Phone 94639 0
+61 736468740
Fax 94639 0
Email 94639 0
[email protected]
Contact person for scientific queries
Name 94640 0
Nicole Marsh
Address 94640 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield Street
Herston, Qld, 4029
Country 94640 0
Australia
Phone 94640 0
+61 736468740
Fax 94640 0
Email 94640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be available for this trial due to Human Research Ethics Committee approved conditions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2765Ethical approval    377895-(Uploaded-24-07-2019-10-58-41)-Study-related document.pdf



Results publications and other study-related documents

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