Overview

This trial is active, not recruiting.

Condition pressure ulcer
Treatments optimal turning, standard care practices, patient sensor
Sponsor Stanford University
Collaborator Leaf Healthcare, Inc.
Start date August 2015
End date January 2016
Trial size 1313 participants
Trial identifier NCT02533726, 33144

Summary

The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.).
optimal turning Patient Turning
Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn.
patient sensor Leaf Healthcare Patient Monitoring Sensor
A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.
(Active Comparator)
Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary.
standard care practices
Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor.
patient sensor Leaf Healthcare Patient Monitoring Sensor
A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.

Primary Outcomes

Measure
Occurrence of Pressure Ulcer as per the National Pressure Ulcer Advisory Panel (NPUAP) criteria for Pressure Ulcer's.
time frame: Subjects will be followed for duration of their ICU admission. Expected average up to 1 week.

Secondary Outcomes

Measure
Compliance to Patient Turning Procedures
time frame: Subjects will be followed for duration of their ICU admission. Expected average up to 1 week.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults (>18 years of age) - Admission to Intensive Care Unit Exclusion Criteria: - Children (<18 years of age) - Adhesive allergy - Physical limitation for sensor application

Additional Information

Official title Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
Principal investigator David Pickham, PhD
Description This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Stanford University.