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

November 6, 2025 updated by: Rachel Cowan, University of Alabama at Birmingham

Sacral Interface Pressure Mapping of Hospital Bed Systems

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-skin breakdown or compromising skin conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Adult Volunteers
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
Low air loss mattress in supine position
Device: Bed B - Head of Bed 0 degrees
Standard hospital mattress in supine position
Device: Bed A - Head of bed at 30 degrees
Low air loss mattress with head of bed at 30 degrees
Device: Bed B - head of bed at 30 degrees
Standard hospital mattress with head of bed at 30 degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Sacral Pressure
Time Frame: minutes 1-3 and minutes 6-8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Rachel Cowan, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2024

Primary Completion (Actual)

October 23, 2024

Study Completion (Actual)

October 23, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300012406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A deidentified data set will be shared upon request contingent on execution of a data sharing/use agreement between the PI's institution and the individual/institution/organization requesting the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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