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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bed A - Head of Bed 0 degrees | Device | Low air loss mattress in supine position |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-skin breakdown or compromising skin conditions
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Cowan, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States |
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.
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The protocol did not include any events between enrollment and assignment. All enrolled participants completed the protocol
Convivence sample of healthy non-disabled adults were recruited from personal and professional contacts of the study team and word of mouth. Recruitment occurred from 6/11/2024 through 10/23/2024
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Bed A - Low air loss mattress with head of bed at 0 degrees Bed B - Standard hospital mattress with head of bed at 0 degrees Bed A - Low air loss mattress with head of bed at 30 degrees Bed B - Standard hospital mattress with head of bed at 30 degrees |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2024 |
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| Bed B - Head of Bed 0 degrees | Device | Standard hospital mattress in supine position |
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| Bed A - Head of bed at 30 degrees | Device | Low air loss mattress with head of bed at 30 degrees |
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| Bed B - head of bed at 30 degrees | Device | Standard hospital mattress with head of bed at 30 degrees |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Bed A - Low air loss mattress with head of bed at 0 degrees Bed B - Standard hospital mattress with head of bed at 0 degrees Bed A - Low air loss mattress with head of bed at 30 degrees Bed B - Standard hospital mattress with head of bed at 30 degrees |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height (inches) | Mean | Standard Deviation | inches |
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| Weight (pounds) | Mean | Standard Deviation | pounds |
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| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 18 participants completed the data collection protocol. 16 participants were included in the analysis. 2 participants were excluded from all analyses after inspection of their data suggested the position of the coccyx had been misidentified. | Posted | Mean | Standard Deviation | mm hg | minutes 1-3 and minutes 6-8 |
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From signing of the informed consent form until getting off the final Bed-Position that was tested. All testing occurred during one visit to the laboratory lasting up to 90 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Bed A - Low air loss mattress with head of bed at 0 degrees Bed B - Standard hospital mattress with head of bed at 0 degrees Bed A - Low air loss mattress with head of bed at 30 degrees Bed B - Standard hospital mattress with head of bed at 30 degrees | 0 | 18 | 0 | 18 | 0 | 18 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Cowan, PhD | University of Alabama at Birmingham | 205-934-5034 | recowan@uabmc.edu |
| Oct 23, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Bed B, Head of Bed 0 degrees Minutes 6-8 |
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| Bed A, Head of Bed 30 degrees Minutes 1-3 |
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| Bed B, Head of Bed 30 degrees Minutes 1-3 |
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| Bed A, Head of Bed 30 degrees Minutes 6-8 |
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| Bed B, Head of Bed 30 degrees Minutes 6-8 |
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| Other |
paired t-tests were used to identify statistically significant differences |