Healthy Volunteer, Pressure Distribution
Conditions
Keywords
Pressure Injury, Pressure Mapping
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.
Interventions
DEVICEBed A - Head of Bed 0 degrees
Low air loss mattress in supine position
DEVICEBed B - Head of Bed 0 degrees
Standard hospital mattress in supine position
DEVICEBed A - Head of bed at 30 degrees
Low air loss mattress with head of bed at 30 degrees
DEVICEBed B - head of bed at 30 degrees
Standard hospital mattress with head of bed at 30 degrees
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Sacral Pressure | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
The protocol did not include any events between enrollment and assignment. All enrolled participants completed the protocol
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Healthy Adult Volunteers | — |
|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 6.6 | — |
| BMI (kg/m2) | 26.1 kg/m2 STANDARD_DEVIATION 3.7 | — |
| Height (inches) | 67.9 inches STANDARD_DEVIATION 4.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 18 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Weight (pounds) | 171.9 pounds STANDARD_DEVIATION 32.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: minutes 1-3 and minutes 6-8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed A, Head of Bed 0 degrees Minutes 1-3 | 17.8 mm hg | Standard Deviation 4.2 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed B, Head of Bed 0 degrees Minutes 1-3 | 21.0 mm hg | Standard Deviation 4.5 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed A, Head of Bed 0 degrees Minutes 6-8 | 17.1 mm hg | Standard Deviation 4.9 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed B, Head of Bed 0 degrees Minutes 6-8 | 21.6 mm hg | Standard Deviation 4.6 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed A, Head of Bed 30 degrees Minutes 1-3 | 17.3 mm hg | Standard Deviation 6 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed B, Head of Bed 30 degrees Minutes 1-3 | 24.9 mm hg | Standard Deviation 8.7 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed A, Head of Bed 30 degrees Minutes 6-8 | 16.9 mm hg | Standard Deviation 5.2 |
| Healthy Adult Volunteers | Peak Sacral Pressure | Bed B, Head of Bed 30 degrees Minutes 6-8 | 25.7 mm hg | Standard Deviation 8.6 |
Comparison: Peak sacral pressure (mmHg) was collected for every minute of the 10 minute recording. Two averages for each test condition were analyzed (Minutes 1-3 (Min1-3) and 6-8 (Min6-8)). These averages capture pressure during two different 5 minute cycles, when conceivably, sacral pressure would differ. Paired t-tests compared pressure of Bed A and Bed B at each time at each head of bed position (4 tests, two-tailed test, alpha=0.05). A Holm-Bonferroni correction controlled type 1 error.p-value: <0.05t-test, 2 sided