Utility of Interface Pressure Mapping

NCT ID: NCT01439581

Last Updated: 2019-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcers Bedsores

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients on mapping systems

Group Type EXPERIMENTAL

Mapping System

Intervention Type DEVICE

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

Patients not on mapping systems

Group Type ACTIVE_COMPARATOR

Non-Mapping System

Intervention Type DEVICE

Standard ICU bed with no mapping system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mapping System

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

Intervention Type DEVICE

Non-Mapping System

Standard ICU bed with no mapping system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wellsense USA Inc.

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rob Behrendt

MICU Unit Educator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Interface Pressure Mapping

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.