Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

NCT ID: NCT02533726

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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.

Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment - Optimal Turning

All patients will have a sensor applied. 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.).

Group Type: EXPERIMENTAL

Optimal Turning

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Control - Standard Care

All patients will have a sensor applied. 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.

Group Type: ACTIVE_COMPARATOR

Standard Care Practices

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

Optimal 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Patient 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.

Intervention Type: OTHER

Other Intervention Names

Patient Turning; Pressure Ulcer Prevention; Leaf Healthcare Patient Monitoring Sensor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leaf Healthcare, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

David Pickham

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Pickham, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford Health Care

Locations

Stanford Health Care

Stanford, California, United States

Countries

United States

References

Pickham D, Ballew B, Ebong K, Shinn J, Lough ME, Mayer B. Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:190. doi: 10.1186/s13063-016-1313-5.

Reference Type: DERIVED

PMID: 27053145 (View on PubMed)

Other Identifiers

33144

Identifier Type: -

Identifier Source: org_study_id