Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Other: Optimal Turning
* Other: Standard Care Practices
* Other: Patient Sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment - Optimal Turning<br>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.). | Other: Optimal Turning<br>* 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.<br>* Other names: Pressure Ulcer Prevention;Other: Patient Sensor<br>* 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.<br>* Other names: Leaf Healthcare Patient Monitoring Sensor;|
| Active Comparator: Control - Standard Care<br>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. | Other: Standard Care Practices<br>* 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.<br>Other: Patient Sensor<br>* 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.<br>* Other names: Leaf Healthcare Patient Monitoring Sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bed Sores, Bedsores, Decubitus Ulcer, Pressure Sore