Last reviewed · How we verify

NCT06661954

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

Completed NA Results posted Last updated 20 November 2025
What this trial tests

NA trial testing Bed A - Head of Bed 0 degrees in Healthy Volunteer in 18 participants. Completed in 23 October 2024.

Timeline
11 October 2024
Primary endpoint
23 October 2024
23 October 2024

Quick facts

Lead sponsorUniversity of Alabama at Birmingham
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment18
Start date11 October 2024
Primary completion23 October 2024
Estimated completion23 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 89, any sex, with Healthy Volunteer or Pressure Distribution. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peak Sacral Pressure Primary · 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.

Bed A, Head of Bed 0 degrees Minutes 1-3
GroupValue95% CI
Healthy Adult Volunteers17.8± 4.2
Bed B, Head of Bed 0 degrees Minutes 1-3
GroupValue95% CI
Healthy Adult Volunteers21.0± 4.5
Bed A, Head of Bed 0 degrees Minutes 6-8
GroupValue95% CI
Healthy Adult Volunteers17.1± 4.9
Bed B, Head of Bed 0 degrees Minutes 6-8
GroupValue95% CI
Healthy Adult Volunteers21.6± 4.6
Bed A, Head of Bed 30 degrees Minutes 1-3
GroupValue95% CI
Healthy Adult Volunteers17.3± 6.0
Bed B, Head of Bed 30 degrees Minutes 1-3
GroupValue95% CI
Healthy Adult Volunteers24.9± 8.7
Bed A, Head of Bed 30 degrees Minutes 6-8
GroupValue95% CI
Healthy Adult Volunteers16.9± 5.2
Bed B, Head of Bed 30 degrees Minutes 6-8
GroupValue95% CI
Healthy Adult Volunteers25.7± 8.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy Volunteer

Currently open trials in the same condition.

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06661954.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing