NCT01439581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
6 years until next milestone

Results Posted

Study results publicly available

August 29, 2018

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 22, 2011

Results QC Date

August 10, 2017

Last Update Submit

September 10, 2019

Conditions

UlcersBedsores

Keywords

patientssusceptible tohospitalacquired pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients on mapping systems

EXPERIMENTAL
Device: Mapping System

Patients not on mapping systems

ACTIVE COMPARATOR
Device: Non-Mapping System

Interventions

Mapping SystemDEVICE

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

Patients on mapping systems
Non-Mapping SystemDEVICE

Standard ICU bed with no mapping system

Patients not on mapping systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older,
  • care giver trained on mapping system

You may not qualify if:

  • Less than 18 years,
  • pregnant women,
  • weight greater 550 lbs, and subjects requiring a specialty mattress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

UlcerPressure Ulcer

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Robert Behrendt
Organization
Henry Ford Health System
Rbehren9@hfhs.org
313-874-9537

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MICU Unit Educator

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 23, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

September 1, 2012

Last Updated

September 12, 2019

Results First Posted

August 29, 2018

Record last verified: 2019-09

Locations

US(1)