Bedsores, Ulcers
Conditions
Keywords
patients, susceptible to, hospital, acquired pressure
Brief summary
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.
Interventions
DEVICEMapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
DEVICENon-Mapping System
Standard ICU bed with no mapping system
Sponsors
Wellsense USA Inc.
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older, * care giver trained on mapping system
Exclusion criteria
* Less than 18 years, * pregnant women, * weight greater 550 lbs, and subjects requiring a specialty mattress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | Time admitted in the Medical Intensive Care Unit | Comparing number of pressure ulcers when using pressure mapping compared to when not. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients on Mapping Systems Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning | 216 |
| Patients Not on Mapping Systems Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning | 212 |
| Total | 428 |
Baseline characteristics
| Characteristic | Patients Not on Mapping Systems | Patients on Mapping Systems | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 74 Participants | 73 Participants | 147 Participants |
| Age, Categorical Between 18 and 65 years | 138 Participants | 143 Participants | 281 Participants |
| Age, Continuous | 56.9 years | 58.7 years | 57.8 years |
| Region of Enrollment United States | 212 participants | 216 participants | 428 participants |
| Sex: Female, Male Female | 102 Participants | 110 Participants | 212 Participants |
| Sex: Female, Male Male | 110 Participants | 106 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 213 | 0 / 209 |
| serious Total, serious adverse events | 0 / 213 | 0 / 209 |
Outcome results
Primary
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Time frame: Time admitted in the Medical Intensive Care Unit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients on Mapping Systems | Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | 2 Participants |
| Patients Not on Mapping Systems | Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | 10 Participants |