Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wellsense USA Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on mapping systems | Experimental |
| |
| Patients not on mapping systems | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mapping System | Device | Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | Comparing number of pressure ulcers when using pressure mapping compared to when not. | Time admitted in the Medical Intensive Care Unit |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients on Mapping Systems | Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning |
| FG001 | Patients Not on Mapping Systems | Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients on Mapping Systems | Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning |
| BG001 | Patients Not on Mapping Systems |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pressure Mapping Reducing Hospital Acquired Pressure Ulcers | Comparing number of pressure ulcers when using pressure mapping compared to when not. | Posted | Count of Participants | Participants | Time admitted in the Medical Intensive Care Unit |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients on Mapping Systems | Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Behrendt | Henry Ford Health System | 313-874-9537 | Rbehren9@hfhs.org |
Not provided
| ID | Term |
|---|---|
| D014456 | Ulcer |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
Not provided
Not provided
Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Not provided
Not provided
Not provided
Not provided
| Non-Mapping System | Device | Standard ICU bed with no mapping system |
|
Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 213 |
| 0 |
| 213 |
| EG001 | Patients Not on Mapping Systems | Mapping System: Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning | 0 | 209 | 0 | 209 |
Not provided
Not provided
| D017437 | Skin and Connective Tissue Diseases |