Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces

NCT06661954 | Completed Results FDA Device

• 1 other identifier: IRB-300012406
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.

Conditions

Healthy Volunteer; Pressure Distribution

Keywords

Pressure Injury; Pressure Mapping

Outcome Measures

Primary Outcomes (1)

• Peak Sacral Pressure

  Peak sacral pressure is defined as the highest pressure within a 9-10 cm squared area under the coccyx. The area under coccyx was identified prior to each condition tested using the pressure mapping system. Presure was recorded continuously for 15 minutes. Because the mattresses tested were advertised as 'cycling' pressure, with the cycles set to 5 minutes, the average of minutes 1-3 and 6-8 were used for analysis. These periods represent different phases of the 'cycling' where sacral pressure would conceivably differ.

  minutes 1-3 and minutes 6-8

Study Arms (1)

Healthy Adult Volunteers

EXPERIMENTAL

One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant.

Device: Bed A - Head of Bed 0 degrees; Device: Bed B - Head of Bed 0 degrees; Device: Bed A - Head of bed at 30 degrees; Device: Bed B - head of bed at 30 degrees

Interventions

Bed A - Head of Bed 0 degrees DEVICE

Low air loss mattress in supine position

Healthy Adult Volunteers

Bed B - Head of Bed 0 degrees DEVICE

Standard hospital mattress in supine position

Healthy Adult Volunteers

Bed A - Head of bed at 30 degrees DEVICE

Low air loss mattress with head of bed at 30 degrees

Healthy Adult Volunteers

Bed B - head of bed at 30 degrees DEVICE

Standard hospital mattress with head of bed at 30 degrees

Healthy Adult Volunteers

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-disabled
• can walk \& stand independently
• can visit UAB SIM Lab once for 45 to 60 minutes

You may not qualify if:

• skin breakdown or compromising skin conditions

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The pressure mapping system used to record peak pressures was a clinical system. This system does not allow for export of the continuous recording. One minute averages had to be computed on the clinical system and then manually transcribed into excel. Participants self-palpated the location of the ischial tuberosities and coccyx. These regions were then labelled on the clinical pressure mapping system. These methodological limitations are assumed to decrease precision.

Results Point of Contact

• Title: Rachel Cowan, PhD
• Organization: University of Alabama at Birmingham

recowan@uabmc.edu

205-934-5034

Study Officials

• Rachel Cowan, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: October 11, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: November 20, 2025
• Results First Posted: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)