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The effect of head of bed elevation on subepidermal moisture at the sacrum and heels in healthy adults: A crossover study

The effect of head of bed elevation on subepidermal moisture at the sacrum and heels in healthy adults: A crossover study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001456741
Enrollment
48
Registered
2022-11-15
Start date
2022-02-28
Completion date
2022-03-31
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 we

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.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

age of 18 or over, with no physical limitations, who self reported being healthy having the capacity to consent

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026