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Trial registered on ANZCTR


Registration number
ACTRN12616000333415
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
15/03/2016
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Date results information initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring tissue reperfusion in two body positions and varied load periods in critically ill patients. (EXTREME II Pressure Study)
Scientific title
In the critically ill adult patient population, what is the impact of severity of illness and body mass index on tissue reperfusion time in the Supine semi-recumbent and Lateral 1/4 turn position at 2.5-hour and 4-hour time intervals?
Secondary ID [1] 288380 0
nil
Universal Trial Number (UTN)
Trial acronym
EXTREME II pressure study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critically ill patients
297384 0
tissue perfusion 297385 0
Condition category
Condition code
Cardiovascular 297568 297568 0 0
Normal development and function of the cardiovascular system
Skin 297569 297569 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Procedures
1. Patient suitability will need to be confirmed on the day of data collection with the registered nurse (RN) assigned to the patient, Clinical Nurse Consultant (CNC), the team leader (usually the CNC), Clinical Co-ordinator (CC) and medical staff member allocated to the patient. A suitable time for data collection will be co-ordinated with relevant staff members of the ICU department
2. When the patient is scheduled for repositioning the bedside nurse will set up the laser Doppler perfusion monitor (LDPM) equipment at the patient bedside. For data collection the patient will be positioned either on their back (supine semi-recumbent position) or side (lateral quarter turn position), as per the routine ICU repositioning schedule. If the patient has been lying on their back, the research nurse and ICU team will position the patient on their side and data collect on the greater trochanter first or vice versa. The research nurse will talk to the patient and ICU team through the data collection process.
3. The research nurse will tape the LDPM to the surface of the sacrum (when positioned on the back) or greater trochanter (when positioned on the side).
4. Once the LDPM is in place a baseline recording will be taken to record the patients normal tissue perfusion (before loading with pressure).
5. After a stable baseline is recorded, the ICU team will complete the repositioning by turning the patient on their back or side.
6. Once the patient is lying in position and the LDPM recording has started, the research nurse will monitor the LDPM recording and the bedside nurse will continue with the patient cares as normal. The patient will remain in the position for 2.5-hours.
7. After 2.5-hours, the patient will be due for repositioning. The research nurse and ICU team will reposition the patient to offload the LDPM and the tissue reperfusion measurements will be recorded. The reperfusion time will be recorded for approximately 10 minutes. The patient’s body weight will be supported with pillows for comfort for the duration of this time.
8. Once data collection has been completed for the first position the above process will be repeated for the second position. The second position will be recorded for a total of 4-hours.
9. After data collection, the patients routine repositioning will continue for the duration of their stay in ICU; the study will only record tissue reperfusion with the LDPM on one occasion.
10. The research nurse will follow up with skin assessments 3-4 times per week to check for PI development until 20 skin checks have been completed or the patient has been discharged from hospital, whichever occurs first.


As the data collection is expected to take 7-8 hours and the study only has one LDPM device the study will only be data collecting a maximum of one patient per day. The eligible patient for the data collection will be the most suitable patient in the ICU that meets study criteria. All patient routine cares will be conducted as normal during this time. If the patients’ health situation changes or they need to be moved from the position during data collection, the data collection will then be ceased as the patients care needs come first. Data collection is only conducted if deemed appropriate by the bedside nurse, Clinical Nurse Consultant and ICU medical team.

The data collection form will be used to document the data and prompt the nurse to check pillow placement and bed angles are set to the guidelines in the study procedures
Intervention code [1] 293685 0
Other interventions
Comparator / control treatment
control group: the 2.5hour time interval before turning (for both the supine and lateral position)

We have selected the 2.5 hour time interval to be the control as it is the minimum standard turn time interval for the ICU as per their turning guidelines (for both the supine and lateral positions). It is standard that patients are turned from their back (supine) to side (lateral) to back to other side unless their medical condition prevents them from turning.

Control group
Active

Outcomes
Primary outcome [1] 297120 0
The primary outcome measure will be time to tissue reperfusion.
A laser doppler perfusion monitor (LDPM) will measure the tissue perfusion from the baseline readings through to the tissue reperfusion time.

Of the 18 participants in each group:
- 9 participants will have 2.5hour side (lateral 1/4 turn position) pressure loading and 4 hour back (supine semi recumbent position) pressure loading.
- 9 participants will 4 hour side (lateral 1/4 turn position) pressure loading and 2.5 hour back (supine semi recumbent position) pressure loading.

Comparision of tissue reperfusion values given by the LDPM for all 108 participants will be completed post data analysis.
Timepoint [1] 297120 0
The participants baseline is recorded for 2 minutes, the participant is positioned to load the area of peak pressure and remains in the position for either 2.5 hours or 4 hours depending on which time period has been allocated to the body position, the participant is rolled to offload the area of peak pressure and the tissue reperfusion is recorded for 10-15 minutes.

Secondary outcome [1] 320071 0
The secondary outcome measure will be PI development.

A specifically designed skin assessment data collection tool will document:
- Date of skin assessment (on data collection and 3-4 days per week until hospital discharge)
- Skin Assessment number (1,2, 3, 4..)
- Is the patient dependant on a repositioning schedule? (yes/no)
- Is there any injury seen on skin assessment? (yes/no)
- Type of injury (PI, skin tear, MASD -IAD, MASD-other)
- Location on body
- Stage or category
- Has the injury been noted prior to this assessment? (yes/no)
- Further comments (known cause, new, healing)
Timepoint [1] 320071 0
a specifically designed skin assessment data collection tool designed for the study will be completed at the time of data collection, repeated 2-3 times per week until the patient is discharged from the hospital or until 20 skin assessments have been achieved. The data will be compared during data analysis.

Eligibility
Key inclusion criteria
Critically ill patients will be included if they:
1. are over 18 years.
2. are mechanically ventilated.
3. have been admitted to the Intensive care unit within the past 72 hours.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Critically ill patients will be excluded if they:
1. are receiving non-invasive ventilation (NIV).
2. are unable to turn on one or more of the body positions.
3. are managed in isolation under contact or droplet or airborne precautions.
4. have a diagnosis of burn injury with greater than 40% TBSA.
5. have a burn injury located over the sacrum or over both hip regions.
6. are scheduled for a surgical procedure in theatre on the day of data collection.
7. are managed on spinal precautions.
8. have a diagnosis of a pelvic fracture and are unable to turn.
9. are receiving palliative care.
10. are agitated and do not obey commands as determined by medical or nursing clinicians.
11. are deemed to be in too much pain to turn, as determined by medical or nursing clinicians.
12. are haemodynamically unstable, as determined by medical or nursing clinicians.13. are on three other research protocols in intensive care.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Data will be entered into the IBM Statistical Package for the Social Science (SPSS) version 23.0. All participants’ scores and data will be de-identified. A random 20% of all data entered will be manually cross checked for accuracy. Descriptive data will be analysed using frequencies, means and percentages as appropriate for the continuous and categorical variables. Fourier analysis will be used to ‘best fit’ a curve to a recorded time series of perfusion data (peak to baseline reperfusion); time to reperfuse. Relationships between variables (both within and between subjects) will be examined using a mixed effects model (split plot ANOVA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5102 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 12569 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 292737 0
Commercial sector/Industry
Name [1] 292737 0
The Wound Management Innovation Cooperative Research Centre (WMI CRC)
Address [1] 292737 0
2, 25 Donkin St, West End QLD 4101
Country [1] 292737 0
Australia
Primary sponsor type
Individual
Name
Professor Fiona Coyer
Address
School of Nursing, Queensland University of Technology and Intensive Care Services, Royal Brisbane & Women's Hospital.
Level 2, Centre for Clinical Nursing,, Building 34. Centre for Clinical Nursing, Building 34. RBWH, Bowen Bridge Road. HERSTON QLD 4029.

Country
Australia
Secondary sponsor category [1] 291465 0
None
Name [1] 291465 0
Address [1] 291465 0
Country [1] 291465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294221 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 294221 0
Human Research Ethics Office
Level 7, Block 7
Royal Brisbane & Women's Hospital,
Metro North Health Service District
Butterfield St., Herston, QLD 4029.

Ethics committee country [1] 294221 0
Australia
Date submitted for ethics approval [1] 294221 0
25/01/2016
Approval date [1] 294221 0
11/03/2016
Ethics approval number [1] 294221 0
HREC/16/QRBW/8

Summary
Brief summary
The research project aims to better understand how pressure injuries occur and to explore blood flow in seriously ill patients in two lying positions used in the intensive care unit (ICU): on the back and on the side, at 2.5-hour and 4-hour time intervals. The body’s ability to carry oxygenated blood to the tissue is tested using non-invasive, pain-free Doppler technology which measures the time taken for the blood flow to return to the small blood vessels in the tissue, near the surface of the skin. The research project will look into the effect patient body mass index (BMI), level of sickness, patient lying position and the effect that length of time in one lying position has on blood flow to the skin for the ICU patients. The patients will be assessed in the first 72-hours of admission, when they are the most ill and skin checks for pressure injuries will be completed 3-4 times per week until the patients leave hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62934 0
Prof Fiona Coyer
Address 62934 0
School of Nursing, Queensland University of Technology and Intensive Care Services, Royal Brisbane & Women's Hospital.
Level 2, Centre for Clinical Nursing, Royal Brisbane & Women's Hospital, Butterfield St., Herston, QLD 4029.
Country 62934 0
Australia
Phone 62934 0
+617 3646 2140
Fax 62934 0
Email 62934 0
f.coyer@qut.edu.au
Contact person for public queries
Name 62935 0
Mrs Jessica Ingleman
Address 62935 0
Level 5, Building 34, Centre for Clinical Nursing, Royal Brisbane & Women's Hospital, Butterfield St., Herston, QLD 4029.
Country 62935 0
Australia
Phone 62935 0
+617 3138 7453
Fax 62935 0
Email 62935 0
j.ingleman@hdr.qut.edu.au
Contact person for scientific queries
Name 62936 0
Prof Fiona Coyer
Address 62936 0
School of Nursing, Queensland University of Technology and Intensive Care Services, Royal Brisbane & Women's Hospital.
Level 2, Building 34, Centre for Clinical Nursing, Royal Brisbane & Women's Hospital, Butterfield St., Herston, QLD 4029.
Country 62936 0
Australia
Phone 62936 0
+61 7 3646 2140
Fax 62936 0
Email 62936 0
f.coyer@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study results will be disseminated in de-identified and aggregate form only (i.e. no individual patients will be referred to, or be able to be identified).
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary