Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000112965
Ethics application status
Approved
Date submitted
8/01/2020
Date registered
7/02/2020
Date last updated
22/11/2021
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
COmparing the use of Midline Catheters versus Peripherally Inserted Central CAtheters for patients requiring peripherally Compatible Therapies: A randomised controlled trial (the COMPACT Trial)
Scientific title
Midline Catheters versus Peripherally Inserted Central Catheters: A randomised controlled trial to compare device failure outcomes for patients requiring prolonged intravenous therapy.
Secondary ID [1] 300192 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
COMPACT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter failure prior to completion of therapy 315750 0
Condition category
Condition code
Public Health 314031 314031 0 0
Health service research
Infection 314032 314032 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be consented, randomised and allocated to one of the two following randomly assigned options:
Arm 1 (Control): Peripherally Inserted Central Catheter (PICC)
Arm 2 (Intervention): Midline Catheter (MC)
PICC and MC insertions will take place in either a dedicated procedure room or at the bedside by a nurse with established skills, using ultrasound, and a sterile technique. Both devices are inserted in the upper arm of the patient but they differ in the length of the device and ultimately, the final tip location. PICCs terminate in the central venous system, ideally at the cavoatrial junction. MCs terminate in the peripheral venous circulation, distal to the axilla.

Strategies that will be implemented to monitor fidelity to the intervention will include comprehensive training and ongoing support for the inserting clinicians.

PICC and MC insertion duration can vary depending on a patient's individual venous access. PICC insertion bookings typically allow for 1 hour. MC insertion is anticipated to be approximately 30 minutes in duration.

The allocated device will remaining insitu until it is removed by the patients’ treating clinicians as per usual clinical practice. For example, if the device is no longer needed, if suspected of infection, is painful, the site is swollen, or the device dysfunctions (e.g. leaks, dislodges or occludes).
Intervention code [1] 316469 0
Treatment: Devices
Intervention code [2] 316470 0
Prevention
Comparator / control treatment
Arm 1 (Control): Peripherally Inserted Central Catheter (PICC)
PICC insertions will take place in either a dedicated procedure room or at the bedside by a nurse with established skills, using ultrasound, and a sterile technique.
PICC insertions typically take up to 1 hour to insert, depending on the patient's individual vascular acess. PICCs are inserted in the upper arm of the patient but the tip of the catheter terminates in the central venous system, ideally at the cavoatrial junction.

The allocated device will remaining insitu until it is removed by the patients’ treating clinicians as per usual clinical practice. For example, if the device is no longer needed, if suspected of infection, is painful, the site is swollen, or the device dysfunctions (e.g. leaks, dislodges or occludes).
Control group
Active

Outcomes
Primary outcome [1] 322436 0
Feasibility: Outcomes to establish feasibility of the protocol and processes will be collected to inform budget and protocol development for a larger, definitive trial.
Feasibility will include five criteria: proportion of those screened who are eligible (>50%), proportion of those eligible who consent (>90%), proportion of those who consent who later withdraw or who are lost to follow up (<5%); proportion who adhere to the randomised protocol (>90%); proportion of missing data (<5%).
Timepoint [1] 322436 0
At the time of trial completion.
Primary outcome [2] 322437 0
All-cause post-insertion failure: A composite of pain, infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis, thrombosis (suspected or confirmed), migration, dislodgement (complete or partial), infection (laboratory confirmed local or bloodstream infection) or incorrect placement (confirmed by ultrasound or x-ray).

These will be assessed by either the Research Nurse (during daily checks); 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] 322437 0
At the time of MC or PICC removal.
Secondary outcome [1] 378537 0
Device dwell-time (time from insertion to removal, in hours).

This will be assessed by either the Research Nurse (during daily checks); 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] 378537 0
At the time of MC or PICC removal.
Secondary outcome [2] 378538 0
Number of insertion attempts (needle punctures to insert device), documented by inserter (or observed by the Research Nurse).
Timepoint [2] 378538 0
At the time of MC or PICC insertion.
Secondary outcome [3] 378539 0
Central Line Associated Bloodstream Infection (CLABSI), as per Centers for Disease Control NHSN 2020 criteria. Relevant only for PICCs, not MC.

This will be confirmed by a blinded infectious diseases specialist using de-identified clinical and microbiological data.
Timepoint [3] 378539 0
48 hours following PICC removal.
Secondary outcome [4] 378540 0
Primary Bloodstream Infection, as per Centers for Disease Control NHSN 2020 criteria. Relevant only for MC, not PICCs.

This will be confirmed by a blinded infectious diseases specialist using de-identified clinical and microbiological data.
Timepoint [4] 378540 0
48 hours following MC removal.
Secondary outcome [5] 378541 0
Patient reported pain of insertion procedure (0-10 verbal rating scale) (as reported by the patient and documented at the bedside by the Research Nurse).
Timepoint [5] 378541 0
At the time of MC or PICC insertion.
Secondary outcome [6] 378542 0
Serious adverse events (including: Intensive Care Unit admission and death), and adverse events (including: skin reactions, bruising and thrombosis). As reported by the patient (skin reactions) or documented at the bedside by the Research Nurse or Treating Team).
Timepoint [6] 378542 0
At the time of MC or PICC removal.
Secondary outcome [7] 378543 0
Patient reported satisfaction of the device (overall), assessed on a (0-10 verbal rating scale).(as reported by the patient and documented at the bedside by the Research Nurse).
Timepoint [7] 378543 0
At the time of MC or PICC insertion.
Secondary outcome [8] 378544 0
Patient reported pain and/or tenderness at insertion site (0-10 verbal rating scale) (as reported by the patient and documented at the bedside by the Research Nurse).
Timepoint [8] 378544 0
At the time of MC or PICC removal.
Secondary outcome [9] 378545 0
Infiltration and Extravasation (composite secondary outcome): Defined as an infusion leaking into subcutaneous tissue (infiltration) with/without surrounding tissue damage (extravasation). Relevant only for MC, not PICCs.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [9] 378545 0
At the time of MC removal.
Secondary outcome [10] 378546 0
Blockage/occlusion (with or without leakage): Defined as the MC or PICC will not infuse (occlusion), with or without leakage out of the entry site when fluid is infused.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [10] 378546 0
At the time of MC or PICC removal.
Secondary outcome [11] 378547 0
Phlebitis: Defined as 2 or more of pain, redness, swelling and a palpable cord. Relevant only for MC, not PICCs.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [11] 378547 0
At the time of MC removal.
Secondary outcome [12] 378548 0
Thombosis (either suspected on confirmed):
Suspected - This will be assessed by the treating clinician, recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Confirmed - Ultrasound/venographic confirmed thrombosed vessel at the MC or PICC site. This will be assessed by a review of the patient's medical records (including ultrasound findings).
Timepoint [12] 378548 0
At the time of MC or PICC removal.
Secondary outcome [13] 378549 0
Migration or Dislodgement (either partial or total) (composite secondary outcome):
Migration - Decrease in external MC or PICC length at insertion site (inner catheter visible).
Partial Dislodgement - Increase in external MC or PICC length at insertion site (inner catheter visible).
Total Dislodgment - MC or PICC completely leaves the vein.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [13] 378549 0
At the time of MC or PICC removal.
Secondary outcome [14] 378582 0
Subsequent device (any vascular access devices) required.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [14] 378582 0
48 hours following MC or PICC removal.

Eligibility
Key inclusion criteria
• Informed consent to participate
• The treating team have referred the patient to receive a PICC with peripherally-compatible intravenous therapy
• Patient expected to receive IV therapy for up to or equal to 29 days
• The treating team has approved the use of either a MC or PICC.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-English speakers without interpreter
• Patient receiving end-of-life care
• Patient with a history of venous thromboembolism or renal disease
• Cognitive barrier to consent (without a SDM)
• Previous enrolment in this study
• Patient receiving chemotherapy treatment
• Patient lives outside Metro North Hospital and Health Service.
• History of intravenous drug use in the last one year

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated allocation will be provided by an independent randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be in a 1:1 ratio between the two study groups.
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
Infection assessors will be blinded; assessors for other outcomes (eg. dislodgement) cannot be blinded.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility outcomes will be reported descriptively and analysed against pre-determined acceptability criteria (e.g. 50% of screened patients eligible, <5% lost to follow up). Baseline variables and secondary outcomes will be compared for clinically significant differences. Kaplan-Meier curves will be drawn. Cox regression will assess the effect of patient and treatment differences as well as group comparisons of post-insertion device failure (p<0.05 significant).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2020
Actual
21/09/2020
Date of last participant enrolment
Anticipated
1/01/2021
Actual
22/01/2021
Date of last data collection
Anticipated
15/01/2021
Actual
22/03/2021
Sample size
Target
110
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15575 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 28959 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 304625 0
University
Name [1] 304625 0
Griffith University
Country [1] 304625 0
Australia
Funding source category [2] 304628 0
Commercial sector/Industry
Name [2] 304628 0
Becton, Dickinson and Company
Country [2] 304628 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 304920 0
None
Name [1] 304920 0
Not applicable
Address [1] 304920 0
Not applicable
Country [1] 304920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305045 0
The Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 305045 0
Ethics committee country [1] 305045 0
Australia
Date submitted for ethics approval [1] 305045 0
28/10/2019
Approval date [1] 305045 0
04/12/2019
Ethics approval number [1] 305045 0
HREC/2019/QRBW/59234
Ethics committee name [2] 305048 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 305048 0
Ethics committee country [2] 305048 0
Australia
Date submitted for ethics approval [2] 305048 0
09/12/2019
Approval date [2] 305048 0
11/12/2019
Ethics approval number [2] 305048 0
GU Ref No. 2019/1009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99090 0
Dr Nicole Marsh
Address 99090 0
Level 2, Building 34
Royal Brisbane and Women’s Hospital
Herston, QLD, 4029
Country 99090 0
Australia
Phone 99090 0
+61 73646 8590
Fax 99090 0
Email 99090 0
[email protected]
Contact person for public queries
Name 99091 0
Emily Larsen
Address 99091 0
Level 2, Building 34
Royal Brisbane and Women’s Hospital
Herston, QLD, 4029
Country 99091 0
Australia
Phone 99091 0
+61 73646 8740
Fax 99091 0
Email 99091 0
[email protected]
Contact person for scientific queries
Name 99092 0
Nicole Marsh
Address 99092 0
Level 2, Building 34
Royal Brisbane and Women’s Hospital
Herston, QLD, 4029
Country 99092 0
Australia
Phone 99092 0
+61 73646 8590
Fax 99092 0
Email 99092 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
The current conditions set by the approving Human Research Ethics Committee/s do not provide approval for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6314Ethical approval    379008-(Uploaded-07-01-2020-17-27-16)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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