Utility of Interface Pressure Mapping

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01439581
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Wellsense USA Inc.
Information provided by (Responsible Party):
Rob Behrendt, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Ulcers Bedsores Device: Mapping System Device: Non-Mapping System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: Patients on mapping systems Device: Mapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning

Active Comparator: Patients not on mapping systems Device: Non-Mapping System
Standard ICU bed with no mapping system

Primary Outcome Measures :
  1. Pressure Mapping Reducing Hospital Acquired Pressure Ulcers [ Time Frame: Time admitted in the Medical Intensive Care Unit ]
    Comparing number of pressure ulcers when using pressure mapping compared to when not.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01439581

United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Wellsense USA Inc.

Responsible Party: Rob Behrendt, MICU Unit Educator, Henry Ford Health System Identifier: NCT01439581     History of Changes
Other Study ID Numbers: Interface Pressure Mapping
First Posted: September 23, 2011    Key Record Dates
Results First Posted: August 29, 2018
Last Update Posted: August 29, 2018
Last Verified: July 2018

Keywords provided by Rob Behrendt, Henry Ford Health System:
susceptible to
acquired pressure