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Trial registered on ANZCTR


Registration number
ACTRN12615001341516
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
9/12/2015
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Date results provided
30/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring Pressures, Tissue Perfusion and Body Positioning: A Pilot Evaluation among critically Ill Patients (EXTREME Pressure Study)
Scientific title
In the critically ill adult patient population, what is the impact of severity of illness and body mass index on interface pressure and tissue reperfusion time in the Supine semi-recumbent and Lateral 1/4 turn position when compared to healthy controls?
Secondary ID [1] 287868 0
Nil known
Universal Trial Number (UTN)
U1111-1176-3292
Trial acronym
EXTREME pressure study pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critically ill patients 296742 0
peak interface pressure 296744 0
tissue reperfusion 296745 0
Condition category
Condition code
Skin 297160 297160 0 0
Normal skin development and function
Cardiovascular 297161 297161 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pilot procedures will be separated into two sets of procedures; one for the healthy participants and the other for the critically ill patients in the Intensive Care Unit (ICU). An indepth procedures guide is prodived for the data collectors with information regarding each step of the data collection process. Following healthy participant recruitment and consent, the participant will be positioned in three body positions: 30 degree semi-recumbent supine, 1/4 lateral turn and prone ( as per the ICU guidelines). The tilt degree of bed angles is checked with a tilt meter and pillow placement confirmed against the study guide. For each position the participant will be placed on a pressure mapping mat (X-sensor pressure mapping system) and data will be collected. The participant will remain in the position for 5-10 minutes and Interface Pressure (IP) and Peak Pressure Index (PPI) measures will be recorded (2 minute recording) after the mattress settling time is complete. Following repositioning (i.e. rolling participant to off load the peak IP), Doppler (Perimed laser doppler perfusion monitor: Periflux 4000, probe 404) data collection will be conducted to measure tissue reperfusion for the points of peak pressure. This includes a 2 minute baseline period, 5 minute loading period and 10 minute offloaded period, as per the study procedures guide.

For the critically ill patients, consent will be given by the patient or substitute decision maker, each patient will be placed in two body positions: 30 degree supine semi-recumbent and 1/4 lateral turn. The Doppler will be attached to the point of peak pressure which was determined by data collection on the healthy adults (sacrum for the supine semi-recumbent position and greater trochanter for the 1/4 lateral turn position) to measure tissue reperfusion when the patient’s weight is offloaded. A total of 6 patients [one in each Body Mass Index (BMI) group in each SOFA category (SOFA <5; SOFA 5 and >)] will be placed on a pressure mapping mat to collect IP and PPI measures.

Data collection is conducted once per participant/patient and patient data collection is co-ordinated with the bedside nurse so data collection is conducted during the routine pressure area care turn time. Due to the nature of the critically ill patients, data collection is dependent on the patients condition and is delayed or cancelled if patients are scheduled for procedures or if their condition deteriorates. Total data collection time is approximately 45 minutes. Data collection consists of a series of patient turns which are supervised by the bedside registered nurse, the ICU patient care officer and the data collection team (a doppler technician and a data collection nurse).

The participant/patient's waist measurement will be taken during data collection and the braden score will be calculated on the day of data collection. All information will be documented on the data collection tool, there are check boxes on the data collection tool to ensure adherence to the protocol.

Patient demographic information, admission details, patient history, patient assessment, SOFA score, APACHE II and III calculations, cardiotonic drug administration and inclusion/exclusion criteria checklist will be completed on the enrollment form for data collection.

Procedures:
1. All healthy adults will be pressure mapped and Doppler data collected. Depending on the patient’s criteria, the patient may be pressure mapped. For pressure mapping, the participant/patient is positioned on top of a pressure mapping mat for 5-10 minutes to allow mattress sewttleing time and a 2 minute recording to measure the distribution of pressure for the areas of body in contact with the bed. The participant/patient will be positioned on their back in a supine semi-recumbent position (the bed head will be raised to 30 degrees, the knees will be raised to 10 degrees, a pillow will be under the participant/patients head and heel wedge will be in place) and on their side in a lateral quarter turn (pillows will be placed to support the head, back and between the knees and the bed will be tilted 10 degrees) for data collection. Healthy adult prone position is based on the ICU guidelines; the participant’s arms are to be placed along the body with the forearms pronated. NOT to be placed in the ‘swimmers’ position. The participant’s arms are NOT to be positioned greater than or equal to 90 degrees to the body.
2. After pressure mapping is complete, the study nurse will use double sided tape to secure the Doppler to the surface of the sacrum (like a band aid). The ICU team will take a 2 minute recording of the participant/patient's baseline tissue perfusion. The ICU team will position the participant/patient in supine semi-recumbent position - the bed head will be raised to 30 degrees, the knees will be raised to 10 degrees, a pillow will be under the participant/patients head and heel wedge will be in place.
3. The participant/patient will remain on their back in the supine semi-recumbent position for 5minutes.
4. After 5 minutes, the participant/patient will be rolled on to their side to offload the Doppler and tissue reperfusion measurements will be recorded for 10 minutes. Once the recordings are saved the Doppler will be gently removed from the participant/patients skin and cleaned/prepared for the next recording.
5. The Doppler will be taped to the surface of the participant/patient’s greater trochanter, the ICU team will take a 2 minute recording of the participant/patient's baseline tissue perfusion.
6. The ICU team will position the participant/patient in the lateral body position to load the Greater Trochanter with pressure- pillows will be placed to support the head, back and between the knees and the bed will be tilted 10 degrees.
7. The participant/patient will remain on their side in the lateral position for 5minutes.
8. After 5 minutes, the participant/patient will be rolled to offload the Doppler and tissue reperfusion measurements will be recorded for 10 minutes.
9. The healthy participants will also be pressure mapped and doppler data collected for the prone position (positioned as per the ICU protocol).
10. All recordings will be reviewed and saved, the patient will be positioned as per the registered nurses request for pressure area care.
Intervention code [1] 293238 0
Other interventions
Comparator / control treatment
The study will recruit 27 participants - 18 ICU patients and 9 healthy adults . The study will recruit patients and healthy adults in three categories of BMI (less than 24.99; 25<29.99; 30 or greater). The study design has been formulated in consultation with an experienced biostatician. For each BMI category we will recruit a total of nine participants, three participants of mid to low acuity (SOFA score of 4.9 or less); three participants of higher acuity (SOFA score of 5 or greater) and three healthy adults, giving a total of 27 participants.
The pilot study will initially recruit 9 healthy adults to test the protocol and data collection tools for IP, PPI, and tissue reperfusion and adjustments will be made as required.
Control group
Active

Outcomes
Primary outcome [1] 296588 0
1) To examine the feasibility of the study protocol in terms of recruitment, setting, study procedures and their impact on nursing and ward practice.

This outcome was measured by a semi-structured interview with the registered nurses. We will also report of screening and recruitment from the data collectors point of view
Timepoint [1] 296588 0
Evaluated at completion of healthy participant recruitment and at the completion of patient data collection
Primary outcome [2] 296589 0
2) To compare Interface Pressure of healthy subjects with critically ill patients in two body positons for a range of BMI groups.
This outcome was measured using the Xsensor X3 pressure mapping system. The pressure mapping system is placed over the foam mattress with the protector cover and a hospital sheet. The participant is placed on top of the pressure mapping system. We take a 2 minute dynamic recording of the participant laying on the mattress in the position, which we save under the participants study number as well as the peak pressure index value, average pressure value and total surface area value which we record on our data collection tool for analysis by the Statistian.
Timepoint [2] 296589 0
We allow a 5-10 minute windown for the mattress to settle and conform to the participants body position before conducting a 2 minute recording of the body position.

Comparision of interface pressure values for participants will be completion of data analysis.
Primary outcome [3] 296590 0
3) To compare tissue reperfusion of healthy subjects with critically ill patients in two body positons for a range of BMI groups. Tissue reperfusion recordings will be collected with the Laser Doppler perfusion monitor (LDPM).
Timepoint [3] 296590 0
The data collection for LDPM is a continual recording from baseline readings through to the tissue reperfusion time.

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 5 minutes, the participant is rolled to offload the area of peak pressure and the tissue reperfusion is recorded for 10 minutes.

Comparision of tissue reperfusion values for participants will be completion of data analysis.
Secondary outcome [1] 318810 0
Severity of illness, measured by the SOFA score
Timepoint [1] 318810 0
Hourly data points from the 24 hour time period 0:00-23:59, are measured on the day before data collection for the critically ill patients. The "worst case scenario" data points are used to create the participants SOFA score.
Secondary outcome [2] 318811 0
Data was entered into the ANZACS data tool which provides Apache II, Apache III and SAPS scoring and risk of death percentage. This is a composite secondary outcome.

This score calculator represents ANZICS modification of the APACHE and SAPS scoring systems with the incorporation of additional diagnoses such as liver transplantation and spinal injuries. It has been created by the ANZICS Centre for Outcome and Resource Evaluation and the ANZIC - Research Centre at Monash University. It is intended for use by researchers and clinicians but is not recommended for directly determining individual patient management.
Timepoint [2] 318811 0
Hourly data points from the 24 hour time period 0:00-23:59, are measured on the day before data collection for the critically ill patients. The highest and lowest value data points are required for the score calculator.
Secondary outcome [3] 318812 0
Braden score
Timepoint [3] 318812 0
This tool is used to assess the participant at the time of data collection prior to positioning the patient. This assessment at the time of data collection gives further information about the patient's pressure injury risk status and can be helpful when reviewing the tissue reperfusion times.

Eligibility
Key inclusion criteria
Healthy adults:
Over 18 years of age.

Critically ill patients:
Over 18 years, mechanically ventilated, SOFA score, BMI category and for the patient to remain ventilated for greater than 48 hours post recruitment to collect data.

The SOFA and BMI categories are key inclusion criteria for this study as the participants are screened to fit into the split plot study design. Participants are split into 3 health status groups: 9 healthy adults, 9 low acuity critically ill patients, 9 high acuity critically ill patients. Each health status has 3 participants in each BMI group (under 25, 25-29.9 and 30 or greater). If the BMI or SOFA group was completed, we excluded potential participants that met the criteria and only looked for participants to complete to other BMI/SOFA groups.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy Adults:
Under 18 years of age

Critically ill patients:
Burns patients with greater than 40% total body surface area burns, burns patients with injury to the sacrum and hip region, unable to be turned in one or more of the body positions, on non-invasive ventilation (NIV), haemodynamically unstable (this will be based on the clinical nurse consultant and bedside registered nurse clinical judgement).

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
Type of endpoint/s
Statistical methods / analysis
This pilot study will recruit 27 participants - 18 ICU patients and 9 healthy adults. The study will recruit patients and healthy adults in three categories of BMI (less than 24.99; 25<29.99; 30 or greater). The study design has been formulated in consultation with an experienced biostatician. For each BMI category we will recruit a total of nine participants, three participants of mid to low acuity (SOFA score of 4.9 or less); three participants of higher acuity (SOFA score of 5 or greater) and three healthy adults, giving a total of 27 participants.
Data will be entered into the IBM Statistical Package for the Social Science (SPSS) version 23.0 by the study investigators/research assistant. 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. 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
31/03/2015
Date of last participant enrolment
Anticipated
Actual
14/09/2015
Date of last data collection
Anticipated
Actual
14/09/2015
Sample size
Target
27
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4606 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 12207 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 292368 0
Charities/Societies/Foundations
Name [1] 292368 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 292368 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, Royal Brisbane & Women's Hospital, Butterfield St., Herston, QLD 4029.
Country
Australia
Secondary sponsor category [1] 291054 0
None
Name [1] 291054 0
Address [1] 291054 0
Country [1] 291054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293838 0
The Human Research Ethics Committee of the Royal Brisbane and Women’s Hospital.
Ethics committee address [1] 293838 0
Ethics committee country [1] 293838 0
Australia
Date submitted for ethics approval [1] 293838 0
24/02/2014
Approval date [1] 293838 0
09/04/2014
Ethics approval number [1] 293838 0
HREC/14/QRBW/37
Ethics committee name [2] 293839 0
QUT University Human Research and Ethics Committee
Ethics committee address [2] 293839 0
Ethics committee country [2] 293839 0
Australia
Date submitted for ethics approval [2] 293839 0
17/04/2014
Approval date [2] 293839 0
06/05/2014
Ethics approval number [2] 293839 0
1400000285

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

Contacts
Principal investigator
Name 61434 0
Prof Fiona Coyer
Address 61434 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 61434 0
Australia
Phone 61434 0
+61 7 3646 2140
Fax 61434 0
Email 61434 0
[email protected]
Contact person for public queries
Name 61435 0
Jessica Ingleman
Address 61435 0
Level 2, Building 34, Centre for Clinical Nursing, Royal Brisbane & Women's Hospital, Butterfield St., Herston, QLD 4029.
Country 61435 0
Australia
Phone 61435 0
+61 7 3138 7453
Fax 61435 0
Email 61435 0
[email protected]
Contact person for scientific queries
Name 61436 0
Fiona Coyer
Address 61436 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 61436 0
Australia
Phone 61436 0
+61 7 3646 2140
Fax 61436 0
Email 61436 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 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 Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.