Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000383167
Ethics application status
Approved
Date submitted
21/02/2019
Date registered
12/03/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
12/03/2019
Date results information initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing intravenous devices among patients with limited vascular access or prolonged therapy: investigating the efficacy of Midline catheters – the MIDLINE study
Scientific title
The Midline Study: a pilot randomised controlled trial to compare the efficacy of Peripheral Venous Catheters with Midline catheters for adult hospitalised patients with limited vascular access or prolonged therapy.
Secondary ID [1] 296721 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The MIDLINE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous device failure prior to completion of therapy 311058 0
Condition category
Condition code
Public Health 309695 309695 0 0
Health service research
Infection 309696 309696 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adult medical and surgical in-patients in this study require intravenous therapy for treatment; consenting patients will receive either a Peripheral Venous Catheter (control) or a Midline Catheter (intervention) for the delivery of this treatment. This device will be inserted by either the Research Nurse or the treating clinician (dependent upon competency and availability).

Intervention: Midline Catheter (MC). MC are approximately 8-20cms in length and are inserted into the upper arm, terminating at the axillary vein.

The randomly allocated device will remain in place until removal as a result of failure, completion of therapy, or routine replacement (if applicable). There will be daily checks of the insertion site to monitor protocol adherence and assess for any complications.
Intervention code [1] 313332 0
Treatment: Devices
Comparator / control treatment
Control group patients will have a Peripheral Venous Catheter (PVC) inserted. PVC are approximately 3-6cms in length and typically inserted into peripheral veins of the lower arm or hand.

The randomly allocated device will remain in place until removal as a result of failure, completion of therapy, or routine replacement (if applicable).There will be daily checks of the insertion site to monitor protocol adherence and assess for any complications.
Control group
Active

Outcomes
Primary outcome [1] 319108 0
Primary outcome: Feasibility (as a composite outcome) will be defined by a measures including: patient eligibility (more than 80% of those screened); consent (more than 80% agree to enrol); protocol adherence (more than 90% receive the allocated intervention); retention (less than 5% of enrolled patients lost to follow up).
Timepoint [1] 319108 0
At the time of trial completion.
Primary outcome [2] 319109 0
Insertion failure: Number of PVCs/midlines that are unable to be successfully inserted.
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] 319109 0
From the time of randomisation until 24 hours post-randomisation.
Primary outcome [3] 319110 0
All-cause post-insertion failure: A composite of pain, infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis, thombosis, dislodgement (complete or partial) or infection (laboratory confirmed local or bloodstream infection). This composite measure incorporates the multifocal path to the same endpoint; PVC failure.

This information will be collected by the research nurse on daily review from either direct observation, consultation with the clinical staff or review of medical record.
Timepoint [3] 319110 0
Daily from device insertion until the time of device removal.
Secondary outcome [1] 366998 0
Number of insertion attempts (needle punctures) required to insert device. All insertion attempts will be assessed by either the Research Nurse (at insertion or 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] 366998 0
From the time of randomisation until 24 hours post-randomisation.
Secondary outcome [2] 366999 0
Time to insert device (from randomisation, to successful insertion). Research staff will calculate time (in minutes) from randomisation to device insertion using relevant information as recorded by clinical staff on a 1 page data collection sheet at the patients bedside and in the patients medical record.
Timepoint [2] 366999 0
From the time of randomisation until the time of device insertion.
Secondary outcome [3] 367001 0
Device dwell-time (time from insertion to removal, in hours). Research staff will calculate time (in hours) from device insertion until removal using relevant information as recorded by clinical staff on a 1 page data collection sheet at the patients bedside and in the patients medical record.
Timepoint [3] 367001 0
At the time of device removal.
Secondary outcome [4] 367002 0
Highest patient reported pain, resulting from insertion attempts (0-10 verbal rating scale).
Timepoint [4] 367002 0
From the time of randomisation until the time of device insertion.
Secondary outcome [5] 367003 0
Patient reported satisfaction regarding insertion procedure (0-10 verbal rating scale).
Timepoint [5] 367003 0
From the time of randomisation until the time of device insertion.
Secondary outcome [6] 367004 0
Serious adverse events (e.g. ICU admission), and adverse events (e.g. insertion site itch or rash, haematoma). This will be assessed by the Research Nurse (during daily checks) and review of medical records.
Timepoint [6] 367004 0
Daily from device insertion until the time of device removal.
Secondary outcome [7] 367005 0
Cost (cost and number of products used, cost of treating complications, staff time for device insertion). This will be collected at the completion of study from information in our existing data set.
Timepoint [7] 367005 0
Daily from device insertion until the time of device removal.
Secondary outcome [8] 367214 0
Infection (laboratory confirmed local or bloodstream infection, as per NHSN criteria): device skin and tip samples for culture may be collected by RNs upon device removal if clinical suspicion of local infection. Blood cultures may be be collected by RNs throughout the life of the device if clinical suspicion of systemic infection.
Timepoint [8] 367214 0
Monitored daily from device insertion until 48 hours post device removal.
Secondary outcome [9] 367215 0
Blockage/Occlusion: Defined as the device will not infuse, with or without leakage out of the entry site when fluid is infused.
This will be established in consultation with the treating clinician or as identified on the bedside collection tool or medical records (during daily checks).
Timepoint [9] 367215 0
Daily from device insertion until the time of device removal.
Secondary outcome [10] 367216 0
Infiltration/Extravasation: Defined as the movement of IV fluid into surrounding tissue (infiltration), with or without resulting tissue damage (extravasation).
This will be observed 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] 367216 0
Daily from device insertion until the time of device removal.
Secondary outcome [11] 367217 0
Dislodgement (either partial or total):
Partial - change in device length at insertion site.
Total - device 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 [11] 367217 0
Daily from device insertion until the time of device removal.
Secondary outcome [12] 367218 0
Phlebitis: Defined as 2 or more signs/symptoms of: pain/tenderness; redness; swelling; or palpable cord/vein streak from the entry site.
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 [12] 367218 0
Daily from device insertion until the time of device removal.
Secondary outcome [13] 367219 0
Thombosis (either suspected on confirmed):
Suspected - as assessed/suspected by the treating clinician
Confirmed - ultrasound/venographic confirmed thrombosed vessel at the device site. This will be assessed by a review of the patient's medical records (including ultrasound findings).
Timepoint [13] 367219 0
Daily from device insertion until the time of device removal.
Secondary outcome [14] 367220 0
Pain (patient reported), resulting from device dwell (assessed on a 0-10 verbal rating scale).
Timepoint [14] 367220 0
Daily from device insertion until the time of device removal
Secondary outcome [15] 372979 0
Subsequent PVC required after allocated device removed. This will be observed 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 [15] 372979 0
Daily until patient discharge, insertion of CVAD or no PVC/MC insitu for 48 hours.

Eligibility
Key inclusion criteria
• equal to or more than 18 years of age;
• The treating team have indicated that the patient is expected to require equal to or more than 5 days peripherally compatible intravenous therapy; or
• difficult access patient (equal to or less than 2 visible and palpable veins);
• Informed consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current positive bloodstream infection (within 24 hours), with the exclusion of a single common skin contaminant (as defined by NHSN)
• Presence of a co-existent central venous access device
• Non-English speakers without interpreter
• Patient receiving end-of-life care
• Cognitive barrier to consent (without a substitute decision maker)
• Previous enrolment in this study

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 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 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
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
1/04/2019
Actual
20/05/2019
Date of last participant enrolment
Anticipated
9/08/2019
Actual
12/03/2020
Date of last data collection
Anticipated
30/08/2019
Actual
31/03/2020
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13163 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25718 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 301301 0
Other Collaborative groups
Name [1] 301301 0
Australian College of Nursing
Country [1] 301301 0
Australia
Funding source category [2] 301996 0
Charities/Societies/Foundations
Name [2] 301996 0
Royal Brisbane and Women's Hospital and Royal Brisbane and Women's Hospital Foundation
Country [2] 301996 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 301776 0
None
Name [1] 301776 0
Address [1] 301776 0
Country [1] 301776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302044 0
Royal Brisbane and Women's Hospital, Human Research Ethics Committee
Ethics committee address [1] 302044 0
Royal Brisbane and Women's Hospital
Level 7, Block 7,
Butterfield Street, Herston
QLD, 4029
Ethics committee country [1] 302044 0
Australia
Date submitted for ethics approval [1] 302044 0
29/10/2018
Approval date [1] 302044 0
05/12/2018
Ethics approval number [1] 302044 0
HREC/2018/QRBW/46295
Ethics committee name [2] 302671 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 302671 0
Office for Research
Bray Centre
Nathan Campus
Griffith University
Kessels Rd, Nathan,
QLD, 4111
Ethics committee country [2] 302671 0
Australia
Date submitted for ethics approval [2] 302671 0
26/11/2018
Approval date [2] 302671 0
10/12/2018
Ethics approval number [2] 302671 0
2018/962

Summary
Brief summary
Peripheral Venous Catheters (PVC) are inserted for the administration of medications and fluid;. two billion are sold worldwide annually. While patient need for PVCs is high, up to 69% fail due to complications such as occlusion or phlebitis necessitating additional PVC insertions to complete treatment. PVC replacements increase healthcare costs (staff time/equipment) and some patients require higher risk central venous device, because they have run out of PVC insertion sites. Midline catheters (MCs) are an alternative to PVCs, increasingly used, but rarely in Queensland, Australia. On average 10cms long, they terminate at the axillary vein, not in the central venous circulation. As with any invasive device, leaking, infection and thrombosis can occur. Their rising popularity is due to concerns that patients’ veins are depleted by multiple consecutive PVCs. There have been no randomised controlled trials (RCTs) comparing these devices to guide practice. This pilot randomised control trial will test the feasibility of a large study comparing PVCs and MCs for patients with difficult vascular access and/or prolonged therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88938 0
Ms Nicole Marsh
Address 88938 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia
Country 88938 0
Australia
Phone 88938 0
+61736468740
Fax 88938 0
Email 88938 0
[email protected]
Contact person for public queries
Name 88939 0
Ms Nicole Marsh
Address 88939 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia
Country 88939 0
Australia
Phone 88939 0
+61736468740
Fax 88939 0
Email 88939 0
[email protected]
Contact person for scientific queries
Name 88940 0
Ms Nicole Marsh
Address 88940 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia
Country 88940 0
Australia
Phone 88940 0
+61736468740
Fax 88940 0
Email 88940 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
1426Ethical approval    Ethical approval valid from 05 December 2018 to 05... [More Details] 376470-(Uploaded-20-02-2019-16-26-21)-Study-related document.pdf



Results publications and other study-related documents

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