Trial Outcomes & Findings for Utility of Interface Pressure Mapping (NCT NCT01439581)
NCT ID: NCT01439581
Last Updated: 2019-09-12
Results Overview
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
428 participants
Primary outcome timeframe
Time admitted in the Medical Intensive Care Unit
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Patients on Mapping Systems
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
|
Patients Not on Mapping Systems
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
212
|
|
Overall Study
COMPLETED
|
216
|
212
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Utility of Interface Pressure Mapping
Baseline characteristics by cohort
| Measure |
Patients on Mapping Systems
n=216 Participants
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
|
Patients Not on Mapping Systems
n=212 Participants
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
143 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Age, Continuous
|
58.7 years
n=5 Participants
|
56.9 years
n=7 Participants
|
57.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
216 participants
n=5 Participants
|
212 participants
n=7 Participants
|
428 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time admitted in the Medical Intensive Care UnitComparing number of pressure ulcers when using pressure mapping compared to when not.
Outcome measures
| Measure |
Patients on Mapping Systems
n=216 Participants
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
|
Patients Not on Mapping Systems
n=212 Participants
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
|
|---|---|---|
|
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
|
2 Participants
|
10 Participants
|
Adverse Events
Patients on Mapping Systems
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Not on Mapping Systems
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place