Pressure Ulcer
Conditions
Keywords
Bed Sores, Bedsores, Decubitus Ulcer, Pressure Sore
Brief summary
The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.
Detailed description
This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices. Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.
Interventions
OTHEROptimal Turning
Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn.
OTHERStandard Care Practices
Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor.
OTHERPatient Sensor
A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.
Sponsors
Leaf Healthcare, Inc.
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\>18 years of age) * Admission to Intensive Care Unit
Exclusion criteria
* Children (\<18 years of age) * Adhesive allergy * Physical limitation for sensor application
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers | Duration of ICU admission (average 1 week) | NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported. * Stage 1: Non-blanchable erythema of intact skin * Stage 2: Partial-thickness skin loss with exposed dermis * Stage 3: Full-thickness skin loss * Stage 4: Full-thickness skin and tissue loss * Unstageable: Obscured full-thickness skin and tissue loss * Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Patient Turning Procedures | Duration of ICU admission (average 1 week) | Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment - Optimal Turning All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor. | 671 |
| Control - Standard Care All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary. | 555 |
| Total | 1,226 |
Baseline characteristics
| Characteristic | Treatment - Optimal Turning | Control - Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 17 | 60 years STANDARD_DEVIATION 18 | 60 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 113 Participants | 82 Participants | 195 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 538 Participants | 458 Participants | 996 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Female | 298 Participants | 253 Participants | 551 Participants |
| Sex: Female, Male Male | 373 Participants | 302 Participants | 675 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 709 | 0 / 603 |
| serious Total, serious adverse events | 0 / 709 | 0 / 603 |
Outcome results
Primary
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported. * Stage 1: Non-blanchable erythema of intact skin * Stage 2: Partial-thickness skin loss with exposed dermis * Stage 3: Full-thickness skin loss * Stage 4: Full-thickness skin and tissue loss * Unstageable: Obscured full-thickness skin and tissue loss * Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration
Time frame: Duration of ICU admission (average 1 week)
Population: Per protocol population according to treatment received (met minimum monitoring period (\>2h) and did not receive both interventions)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment - Optimal Turning | Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers | 5 Participants |
| Control - Standard Care | Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers | 15 Participants |
Comparison: Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).p-value: 0.01295% CI: [0.1, 0.75]Fisher Exact
Comparison: Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.p-value: 0.01595% CI: [0.06, 0.74]Fisher Exact
Secondary
Compliance With Patient Turning Procedures
Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.
Time frame: Duration of ICU admission (average 1 week)
Population: Per protocol population according to treatment received (met minimum monitoring period (\>2h) and did not receive both interventions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Optimal Turning | Compliance With Patient Turning Procedures | 67 percentage of time | Standard Deviation 19.5 |
| Control - Standard Care | Compliance With Patient Turning Procedures | 54 percentage of time | Standard Deviation 22.3 |