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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pressure injury

Condition category

Condition code

Injuries and Accidents

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]

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]

The effect of head of bed elevation 30 degrees versus 60 degrees on subepidermal moisture measurements at the sacrum in healthy adults

Timepoint [1]

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]

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]

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]

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]

Secondary outcome [1]

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]

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]

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]

Secondary outcome [3]

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]

Secondary outcome [4]

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]

Secondary outcome [5]

The effect of a 60-minute washout period on SEM measures at the sacrum after 30 minutes of loading.

Timepoint [5]

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]

The effect of a 60-minute washout period on SEM measures at the left heel after 30 minutes of loading.

Timepoint [6]

Secondary outcome [7]

The effect of a 60-minute washout period on SEM measures at the right heel after 30 minutes of loading.

Timepoint [7]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4215 - Southport

Recruitment postcode(s) [2]

4131 - Meadowbrook

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith university

Address [1]

1 Parklands Drive, Southport, QLD 4215

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

1 Parklands Drive, Southport, QLD, 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics committee

Ethics committee address [1]

170 Kessels Road, Nathan Qld 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/02/2022

Ethics approval number [1]

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

Mrs Annette McLaren-Kennedy

Address

Griffith University Gold Coast
1 Parkland Road, Southport QLD 4215

Country

Australia

Phone

+61 7 5552 8518

Fax

annette.mclaren-kennedy@griffithuni.edu.au

Contact person for public queries

Name

Annette McLaren-Kennedy

Address

Griffith University Gold Coast
1 Parkland Road, Southport QLD 4215

Country

Australia

Phone

+61 7 5552 8518

Fax

annette.mclaren-kennedy@griffithuni.edu.au

Contact person for scientific queries

Name

Annette McLaren-Kennedy

Address

Griffith University Gold Coast
1 Parkland Road, Southport QLD 4215

Country

Australia

Phone

+61 7 5552 8518

Fax

annette.mclaren-kennedy@griffithuni.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The effect of head of bed elevation on sacral and heel subepidermal moisture in healthy adults: A randomised crossover study.	2023	https://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.

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Documents added automatically