Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

Pressure Ulcer Clinical Trial

— LS-HAPU  

Official title:

Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533726
• Other study ID #: 33144
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: September 13, 2017
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1312
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Other:
• 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.
• 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
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.

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Leaf Healthcare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers	NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.; Stage 1: Non-blanchable erythema of intact skin; Stage 2: Partial-thickness skin loss with exposed dermis; Stage 3: Full-thickness skin loss; Stage 4: Full-thickness skin and tissue loss; Unstageable: Obscured full-thickness skin and tissue loss; Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration	Duration of ICU admission (average 1 week)
Secondary	Compliance With Patient Turning Procedures	Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.	Duration of ICU admission (average 1 week)