Trial Outcomes & Findings for Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers (NCT NCT02533726)
NCT ID: NCT02533726
Last Updated: 2018-04-09
Results Overview
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
COMPLETED
NA
1312 participants
Duration of ICU admission (average 1 week)
2018-04-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Initial Allocation
STARTED
|
659
|
653
|
|
Initial Allocation
COMPLETED
|
659
|
653
|
|
Initial Allocation
NOT COMPLETED
|
0
|
0
|
|
Treatment
STARTED
|
709
|
603
|
|
Treatment
Per Protocol Population
|
671
|
555
|
|
Treatment
COMPLETED
|
709
|
603
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers
Baseline characteristics by cohort
| Measure |
Treatment - Optimal Turning
n=671 Participants
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.
|
Control - Standard Care
n=555 Participants
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.
|
Total
n=1226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 17 • n=5 Participants
|
60 years
STANDARD_DEVIATION 18 • n=7 Participants
|
60 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
551 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
373 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
113 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
538 Participants
n=5 Participants
|
458 Participants
n=7 Participants
|
996 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
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
Outcome measures
| Measure |
Treatment - Optimal Turning
n=671 Participants
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.
|
Control - Standard Care
n=555 Participants
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.
|
|---|---|---|
|
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
|
5 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 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)
Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.
Outcome measures
| Measure |
Treatment - Optimal Turning
n=671 Participants
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.
|
Control - Standard Care
n=555 Participants
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.
|
|---|---|---|
|
Compliance With Patient Turning Procedures
|
67 percentage of time
Standard Deviation 19.5
|
54 percentage of time
Standard Deviation 22.3
|
Adverse Events
Treatment - Optimal Turning
Control - Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr David Pickham
Stanford University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place