We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01439581
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : March 5, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2011
Primary Completion Date : October 2011
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arms and Interventions

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: Mapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning


Outcome Measures

Primary Outcome Measures :
  1. Pressure Mapping Reducing Hospital Acquired Pressure Ulcers [ Time Frame: Time admitted in the Medical Intensive Care Unit ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01439581


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

Responsible Party: Rob Behrendt, MICU Unit Educator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01439581     History of Changes
Other Study ID Numbers: Interface Pressure Mapping
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

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