Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001174471
Ethics application status
Approved
Date submitted
11/08/2016
Date registered
26/08/2016
Date last updated
19/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of nasogastric and endotracheal tube securement devices, preventative dressings and topical skin applications for reducing device-related pressure injuries in intensive care patients; a pilot study
Scientific title
Efficacy of nasogastric and endotracheal tube securement devices, preventative dressings and topical skin applications for reducing device-related pressure injuries in intensive care patients; a pilot study
Secondary ID [1] 289912 0
Nil known
Universal Trial Number (UTN)
U1111-1186-2392
Trial acronym
REMEDy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 299880 0
Pressure injuries 299881 0
Condition category
Condition code
Skin 299784 299784 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms of the study described below; Arm 1 - Nasogastric (NGT) securement devices with two interventions and a control; and Arm 2 - Endotracheal tube (ETT) securement devices with two interventions and a control.

ARM 1 (Wide bore NGT are left in situ for 3-5 days and then replaced with a fine bore NGT which can remain in situ indefinitely).
Subgroup 1A - NGT secured with tapes; Subgroup 1B NGT secured to ETT with TubeSAFE (Registered Trademark) clip.
Subgroup 1A participants’ NGT will be secured using self-adhesive tape (Hypafix [Registered Trademark], BSN Medical) attaching one end of the cotton tape to the nose over an anchoring dressing (DuoDERM [Registered Trademark] Extra Thin Dressing, ConvaTec), and attaching the other end to the nasogastric tube according to specific instructions.
Subgroup 1B participants’ NGT will be secured using a TubeSAFE [Registered Trademark] clip which attaches the NGT to the ETT.
All participants in subgroup 1A and 1B will receive the following intervention:
1) 12-hourly (i.e. each shift) application of 3M [Trademark] Cavilon No Sting Barrier film [Trademark] wipes, pre-packaged barrier wipes, on the nare surface around the device
2) Daily application of Mepilex [Registered Trademark] Lite (Molnlycke Health Care), a thin dressing, to pad the nare surface surrounding the device
3) Application of foam padding (3M), cut to wrap around the portion of the device in contact with the nare
4) 3-hourly assessment of the skin surrounding the device
5) 3-hourly repositioning of the device
6) Shift by shift documentation of all assessment, device positions, prevention strategies.

ARM 2 (ETTs can remain in situ for 2-3 weeks depending on the patients projected clinical trajectory)
Subgroup 2A - ETT secured with AnchorFast [Trademark] (Hollister [Registered Trademark] Inc.) ETT attachment device.
All participants in this subgroup will receive the following intervention:
1) The participant’s cheek skin is clean, dry with no oily residue and no barrier wipe is applied
2) Tube attachment device applied and to remain in situ up to 5 days (as per manufacturer’s instructions)
3) Daily application of Mepilex [Registered Trademark] Lite (Molnlycke Health Care), a thin dressing, to pad the skin surface in the corners of the mouth
4) 3-hourly assessment of the skin surrounding the device
5) 3-hourly repositioning of ETT (right, centre or left)
6) Shift by shift documentation of all assessment, device position, prevention strategies.

Subgroup 2B - ETT secured with tape and foam roll
Subgroup 2B participants’ ETT will be secured using cotton tape secured around the ETT and tied around participants’ neck using foam to protect the skin at the nape of the neck and the cheeks.
All participants in this subgroup will receive the following intervention:
1) 12-hourly application of a barrier wipe on the skin surface surrounding the device
2) 12-hourly repositioning of the device by resecuring the device (i.e. application of new tape and foam roll)
3) Daily application of Mepilex [Registered Trademark] Lite (Molnlycke Health Care), a thin padded dressing, on the skin/mucosal surface (corners of the mouth) surrounding the device
4) 3-hourly assessment of the skin underneath the device
5) Shift by shift documentation of all assessment, device position, prevention strategies.

If the participant is eligible for both the NGT and ETT arms of the study they will be randomised to a subgroup in both arms. If a participant has both a NGT and ETT they will be first randomised to one of the three Arm 1 NGT subgroups (intervention [Subgroup 1A or Subgroup 1B] or the control group [Subgroup 1C]). Then the participant will be randomised to one of the three subgroups in Arm 2 ETT (intervention [Subgroup 2A or Subgroup 2B] or the control [Subgroup 2C]).

The devices (NGTs and and ETTs) will be inserted respectively by appropriately trained nursing or medical personnel. Following intensive onsite training by the study investigators, bedside registered nurses in the intensive care units will administer the interventions. Adherence to the intervention delivery will be monitored by research nurses through completion of a checklist as part of the daily data collection. Feedback will be provided to the bedside registered nurses delivering the intervention.
Intervention code [1] 295594 0
Treatment: Other
Intervention code [2] 295716 0
Treatment: Devices
Intervention code [3] 295717 0
Prevention
Comparator / control treatment
Arm 1
Subgroup 1C - Control - Participants' NGT will be secured using Naso-fix (ConvaTec Inc.), a 'mushroom' shaped adhesive tape configuration. All participants in the control group will receive standard care, i.e. the current standard of care in the ICU:
1) shift by shift assessment of the device
2) ad hoc repositioning of the device
3) ad hoc documentation of the device position (left or right).

Arm 2
Subgroup 2C - Control - Participants' ETT will be secured with either an AnchorFast (Trademark) (Hollister [Registered Trademark] Inc.) ETT attachment device or cotton tape and foam. Choice of ETT securement in the control group will be according to standard care guidelines at each site. Participants in the control group will also receive:
1) shift by shift assessment of the device
2) ad hoc repositioning of the device
3) ad hoc documentation of the device position (left, middle or right).
Control group
Active

Outcomes
Primary outcome [1] 299254 0
Primary outcome: development of any stage medical device-related pressure injuries (MDR PI). The primary outcome will be assessed by direct clinical examination of the skin surrounding the device. Diagnosis of a mucosal or stage 2 MDR PI will be made using current international staging guidelines for classification of pressure injuries i.e.. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Australia; 2014
Timepoint [1] 299254 0
The primary outcome measure will be assessed daily for the duration of device use and follow-up will occur for up to 72 hours in the following circumstances:
1) If the participant is in the ICU and the device is removed
2) If the participant is discharged to the ward with the device insitu (i.e. NGTs only)
Secondary outcome [1] 326655 0
Length of time to any stage MDR PI occurrence.

The secondary outcome will be assessed by direct clinical examination of the skin surrounding the device and documentation of time to PI occurrence. Diagnosis of a mucosal or stage 2 MDR PI will be made using current international staging guidelines for classification of pressure injuries i.e.i.e.. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Australia; 2014 .
Timepoint [1] 326655 0
The measure will be assessed daily for the duration of device use until 72 hours post discharge from ICU.
Secondary outcome [2] 327074 0
Severity of staging of MDR PI.

The secondary outcome will be assessed by direct clinical examination of the skin surrounding the device. Diagnosis of a mucosal or stage 2 MDR PI will be made using current international staging guidelines for classification of pressure injuries i.e.. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Australia; 2014 .
Timepoint [2] 327074 0
The measure will be assessed daily for the duration of device use until 72 hours post discharge from ICU.

Eligibility
Key inclusion criteria
All ICU patients = or >18 years who have a NGT and/or ETT in situ
Patients who are expected to remain in ICU > 24 hours
NGT or ETT inserted a maximum of 12 hours prior to ICU admission
Patients readmitted to ICU with no oral or nasal skin injury present
NGT arm only - must have wide bore NGT and an ETT in situ.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Burn patients with an ETT wired in place (ETT arm only)
Patients with NGT sutured in place or nasal bridle (NGT arm only)
Patients with facial trauma
Traumatic brain injured patients requiring intracranial pressure monitoring and/or ventricular drainage of cerebrospinal fluid
Cervical spine injured patients who have a hard collar in situ
Hirsute patients with beards where patient permission to shave is not possible
Patients who are receiving non-invasive ventilation
Patients with a device (NGT or ETT) predicted to be in situ < 48 hours.
Patients with a community or hospital-acquired NGT or ETT PI diagnosed within 24 hours of admission to the ICU.
Patients on whom treatment is withdrawn or who are being palliated.
Patients currently enrolled on three studies in the ICU.

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 not concealed. Although patients will be masked to group allocation, it is not practicable to mask bedside ICU RNs (who will provide the interventions) and research nurses (who will monitor processes of care).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants in each arm (NGT or ETT) will be randomised into one of three subgroups. Study groups will be assigned using a computer generated random number generation for both arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size
75-100 participants meeting the inclusion criteria will be enrolled with 12-17 participants per group.
Statistical Analysis Plan
Data for both clinical and feasibility outcomes will be analysed descriptively using frequencies, and means as percentages, as appropriate for continuous and categorical variables. Kaplan-Meier survival analysis will be used to compare time to new MDR PI events between subgroups in each arm. Study data will be used to undertake a sample size calculation for the larger follow on study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2017
Actual
2/03/2017
Date of last participant enrolment
Anticipated
31/12/2017
Actual
14/12/2017
Date of last data collection
Anticipated
12/01/2018
Actual
18/12/2017
Sample size
Target
100
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6470 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 14025 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 294281 0
Other Collaborative groups
Name [1] 294281 0
Wound Management Innovation CRC
Country [1] 294281 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434;
Brisbane,
QLD 4001.
Country
Australia
Secondary sponsor category [1] 293115 0
None
Name [1] 293115 0
Address [1] 293115 0
Country [1] 293115 0
Other collaborator category [1] 279318 0
Hospital
Name [1] 279318 0
Royal Brisbane and Women's Hospital
Address [1] 279318 0
Intensive Care Services
Royal Brisbane and Women's Hospital
Level 3 Ned Hanlon Building
Butterfield Street
Herston, QLD, 4029
Country [1] 279318 0
Australia
Other collaborator category [2] 279319 0
Hospital
Name [2] 279319 0
Nicola Barker-Gregory
Address [2] 279319 0
Intensive Care Unit
Level 2
Redcliffe Hospital Metro North Hospital and Health Service Locked Bag 1, Redcliffe QLD 4020
Country [2] 279319 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295713 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 295713 0
Ethics committee country [1] 295713 0
Australia
Date submitted for ethics approval [1] 295713 0
29/08/2016
Approval date [1] 295713 0
14/10/2016
Ethics approval number [1] 295713 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1265 1265 0 0
/AnzctrAttachments/371283-REMEDy Study RBWH HREC 16-428 signed approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 68190 0
Prof Fiona Coyer
Address 68190 0
School of Nursing, Queensland University of Technology and the Intensive Care Services Department, Royal Brisbane & Women's Hospital.
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Butterfield St., Herston, QLD 4029.
Country 68190 0
Australia
Phone 68190 0
+61 4380 49714
Fax 68190 0
Email 68190 0
[email protected]
Contact person for public queries
Name 68191 0
Fiona Coyer
Address 68191 0
School of Nursing, Queensland University of Technology and the Intensive Care Services Department, Royal Brisbane & Women's Hospital.
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Butterfield St., Herston, QLD 4029.
Country 68191 0
Australia
Phone 68191 0
+61 7 3646 2140
Fax 68191 0
Email 68191 0
[email protected]
Contact person for scientific queries
Name 68192 0
Fiona Coyer
Address 68192 0
School of Nursing, Queensland University of Technology and the Intensive Care Services Department, Royal Brisbane & Women's Hospital.
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Butterfield St., Herston, QLD 4029.
Country 68192 0
Australia
Phone 68192 0
+61 4380 49714
Fax 68192 0
Email 68192 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSecurement to prevent device-related pressure injuries in the intensive care unit: A randomised controlled feasibility study.2020https://dx.doi.org/10.1111/iwj.13432
N.B. These documents automatically identified may not have been verified by the study sponsor.