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Trial registered on ANZCTR


Registration number
ACTRN12622001456741
Ethics application status
Approved
Date submitted
11/11/2022
Date registered
15/11/2022
Date last updated
15/11/2022
Date data sharing statement initially provided
15/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of head of bed elevation on subepidermal moisture at the sacrum and heels in healthy adults: A crossover study
Scientific title
The effect of head of bed elevation on subepidermal moisture at the sacrum and heels in healthy adults: A crossover study
Secondary ID [1] 308391 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure injury 328189 0
Condition category
Condition code
Injuries and Accidents 325241 325241 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was a 2x2 crossover design to measure the subepidermal moisture at the sacrum and heels of healthy adults using the Provizio(R) SEM Scanner. Participants were required for a two hour period where they received two 30-minute interventions, one laying supine with 30° head of bed elevation and one with 60° head of bed elevation, separated by a 60-minute washout period. During each interventions participants were asked to not move or cross their legs for the 30 minute time. Participants were observed throughout the intervention by the primary researcher. Subepidermal moisture measurements are taken before and after each 30-minute intervention by a registered nurse (primary researcher) trained in the use of the SEM scanner. The SEM scanner was placed in contact with the skin in six locations around the sacrum and four around each heel. These bony prominences are the most common areas of pressure injuries in hospitalised adults. Increased head of bed elevation is recognised as increasing the risk to the sacrum and heels due to gravitational shear forces and thus it is expected that the precursor to pressure injuries of increased subepidermal moisture would also increase after a period of time.
Intervention code [1] 324843 0
Early detection / Screening
Comparator / control treatment
The study design was a randomised crossover study and therefore each participant was there own comparator. It was hypothesised that 60 degrees head of bed elevation would increase SEM readings and therefore measures after 30 minutes at 30 degrees head of bed elevation could be considered the comparator. Each participant was randomly allocated to the starting position of either 30 or 60 degrees head of bed elevation and partook in both positions during the study.
Control group
Active

Outcomes
Primary outcome [1] 333094 0
The effect of head of bed elevation 30 degrees versus 60 degrees on subepidermal moisture measurements at the sacrum in healthy adults
Timepoint [1] 333094 0
To test the effect of head of bed position, SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. Therefore the timepoints for the primary outcome in this 2 hour study will be at 30 minutes and at 120 minutes
Primary outcome [2] 333115 0
The effect of head of bed elevation 30 degrees versus 60 degrees on subepidermal moisture measurements at the left heel in healthy adults
Timepoint [2] 333115 0
To test the effect of head of bed position SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. Therefore the timepoints for the primary outcome in this 2 hour study will be at 30 minutes and at 120 minutes.
Primary outcome [3] 333116 0
The effect of head of bed elevation 30 degrees versus 60 degrees on subepidermal moisture measurements at the right heel in healthy adults
Timepoint [3] 333116 0
To test the effect of head of bed position SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. Therefore the timepoints for the primary outcome in this 2 hour study will be at 30 minutes and at 120 minutes.
Secondary outcome [1] 415770 0
The effect of age on SEM measures after 30 minutes of loading in a supine position with head of bed elevated at 30 degrees and again at 60 degrees.
Timepoint [1] 415770 0
SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. The timepoints for this secondary outcome in this 2 hour study will be at 30 minutes and at 120 minutes
Secondary outcome [2] 415866 0
The effect of sex on SEM measures after 30 minutes of loading in a supine position with head of bed elevated at 30 degrees and again at 60 degrees.
Timepoint [2] 415866 0
SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. The timepoints for this secondary outcome in this 2 hour study will be at 30 minutes and at 120 minutes
Secondary outcome [3] 415867 0
The effect of BMI on SEM measures after 30 minutes of loading in a supine position with head of bed elevated at 30 degrees and again at 60 degrees.
Timepoint [3] 415867 0
SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. The timepoints for this secondary outcome in this 2 hour study will be at 30 minutes and at 120 minutes
Secondary outcome [4] 415868 0
The effect of skin type (pigmentation) on SEM measures after 30 minutes of loading in a supine position with head of bed elevated at 30 degrees and again at 60 degrees.
Timepoint [4] 415868 0
SEM measures will be taken after 30 minutes in each of two positions which are separated by a 60-minute washout period. The timepoints for this secondary outcome in this 2 hour study will be at 30 minutes and at 120 minutes
Secondary outcome [5] 415869 0
The effect of a 60-minute washout period on SEM measures at the sacrum after 30 minutes of loading.
Timepoint [5] 415869 0
SEM measures will be taken before participants are asked to lay on the bed for 30 minutes in each of two positions which are separated by a 60-minute washout period. Therefore the timepoints for this secondary outcome in this 2 hour study will be at 0 minutes and at 90 minutes.
Secondary outcome [6] 415870 0
The effect of a 60-minute washout period on SEM measures at the left heel after 30 minutes of loading.
Timepoint [6] 415870 0
SEM measures will be taken before participants are asked to lay on the bed for 30 minutes in each of two positions which are separated by a 60-minute washout period. Therefore the timepoints for this secondary outcome in this 2 hour study will be at 0 minutes and at 90 minutes.
Secondary outcome [7] 415871 0
The effect of a 60-minute washout period on SEM measures at the right heel after 30 minutes of loading.
Timepoint [7] 415871 0
SEM measures will be taken before participants are asked to lay on the bed for 30 minutes in each of two positions which are separated by a 60-minute washout period. Therefore, the timepoints for this secondary outcome in this 2 hour study will be at 0 minutes and at 90 minutes.

Eligibility
Key inclusion criteria
age of 18 or over,
with no physical limitations,
who self reported being healthy
having the capacity to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Over 2 meters tall
Having poor skin integrity
Having a prior pressure injury at the sacrum and heels
On long-term steroids
Pregnancy

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software - PASS, prepared by a statistician
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A planned sample size of 56 (including a 20% attrition rate) was determined, based on an effect size of 0.49, calculated from an unpublished pilot study in which 20 healthy adults held a 60° HOBE posture for 120 minutes and sacral SEM deltas were compared, a 0.05 significance level and 90% power.
Paired t-tests were conducted to test within individual differences of the mean of the absolute SEM values and SEM deltas and univariate linear regressions were used to test the influence of participants’ characteristics (age, sex, BMI, skin type) on SEM measures. Post hoc power analyses were completed to confirm the sample size was large enough to rule out the chance as the reason for the findings. A Pearson correlation was used to analyse the consistency of technique of using the SEM scanner between two researchers. Differences were considered statistically significant with a p-value of <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/02/2022
Date of last participant enrolment
Anticipated
Actual
31/03/2022
Date of last data collection
Anticipated
Actual
12/04/2022
Sample size
Target
56
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 38966 0
4215 - Southport
Recruitment postcode(s) [2] 38968 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 312636 0
University
Name [1] 312636 0
Griffith university
Country [1] 312636 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
1 Parklands Drive, Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 314249 0
None
Name [1] 314249 0
Address [1] 314249 0
Country [1] 314249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311952 0
Griffith University Human Research Ethics committee
Ethics committee address [1] 311952 0
170 Kessels Road, Nathan Qld 4111
Ethics committee country [1] 311952 0
Australia
Date submitted for ethics approval [1] 311952 0
Approval date [1] 311952 0
11/02/2022
Ethics approval number [1] 311952 0
GU Ref No: 2022/060

Summary
Brief summary
This crossover study will examine the effect of body position (30 versus 60 degrees head of bed elevation) on moisture under the skin (subepidermal moisture), at the sacrum (the lower back) and at the heels, in healthy adults. When pressure is applied to the skin, there is a possibility of blood and lymphatic vessel being compressed resulting in inflammation and oedema (increased moisture). This increased moisture is not visible on the skin’s surface; however, technology is available to measure it. It is understood if the pressure is relieved then the increased moisture resolves quickly and is of little consequence to overall health; however, if pressure is maintained PI has the potential to ensue. PI commonly occur over skin that covers bony areas, like the sacrum or heels. By examining if body position influences oedema development in healthy adults we aim to contribute baseline information to inform future studies of populations at greater risk of PI and operational procedures in using the technology.
To assess the amount of subepidermal moisture in the tissue at the sacrum and heel, the Bruin Biometrics Provizio Sub-Epidermal Moisture (SEM) scanner will be used. The Provisio SEM scanner is a non-invasive, hand-held device that is used in healthcare clinical practice in the United States of America. The Provizio scanner detects the capacity of tissue to hold electrical charge, known as capacitance by light contact between the disposable sensor (one per participant) and the skin.
Tissue will have a larger capacitance with increased moisture levels, as in the case of oedema. The Provizio SEM scanner calculates the capacitance at specific points of contact and computes the delta reading, being the difference between the highest and lowest measurement at an anatomical location. Research to date is suggesting the Provizio delta reading of greater than 0.6 units at the sacrum or heels indicates an increased risk of PI. There is however a gap in knowledge on whether the position prior to utilising this medical device influences the readings.
Because each participant is measured in both body positions, the crossover design allows the research team to compare measurements in different positions while limiting individual confounding factors. To attempt to remove any influence of the first position on the second the order of position will be randomly allocated and there will be a 60-minute ‘washout’ period between each position where the participant will be off the bed and be able to walk around. The study will take place over a two-hour period at Griffith University’s School of Nursing and Midwifery clinical laboratories on the Gold Coast.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122950 0
Mrs Annette McLaren-Kennedy
Address 122950 0
Griffith University Gold Coast
1 Parkland Road, Southport QLD 4215
Country 122950 0
Australia
Phone 122950 0
+61 7 5552 8518
Fax 122950 0
Email 122950 0
[email protected]
Contact person for public queries
Name 122951 0
Annette McLaren-Kennedy
Address 122951 0
Griffith University Gold Coast
1 Parkland Road, Southport QLD 4215
Country 122951 0
Australia
Phone 122951 0
+61 7 5552 8518
Fax 122951 0
Email 122951 0
[email protected]
Contact person for scientific queries
Name 122952 0
Annette McLaren-Kennedy
Address 122952 0
Griffith University Gold Coast
1 Parkland Road, Southport QLD 4215
Country 122952 0
Australia
Phone 122952 0
+61 7 5552 8518
Fax 122952 0
Email 122952 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
It is not planned to share the individual participant data at present.


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
EmbaseThe effect of head of bed elevation on sacral and heel subepidermal moisture in healthy adults: A randomised crossover study.2023https://dx.doi.org/10.1016/j.jtv.2023.01.009
N.B. These documents automatically identified may not have been verified by the study sponsor.