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Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers (LS-HAPU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533726
Recruitment Status : Completed
First Posted : August 27, 2015
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Leaf Healthcare, Inc.
Information provided by (Responsible Party):
David Pickham, Stanford University

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Other: Optimal Turning Other: Standard Care Practices Other: Patient Sensor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
Study Start Date : August 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: 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.).
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.
Other Names:
  • Patient Turning
  • Pressure Ulcer Prevention

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.
Other Name: Leaf Healthcare Patient Monitoring Sensor

Active Comparator: 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.
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.

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.
Other Name: Leaf Healthcare Patient Monitoring Sensor




Primary Outcome Measures :
  1. Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers [ Time Frame: Duration of ICU admission (average 1 week) ]

    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


Secondary Outcome Measures :
  1. Compliance With Patient Turning Procedures [ Time Frame: Duration of ICU admission (average 1 week) ]
    Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533726


Locations
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United States, California
Stanford Health Care
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
Leaf Healthcare, Inc.
Investigators
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Principal Investigator: David Pickham, PhD Stanford Health Care
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Pickham, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02533726    
Other Study ID Numbers: 33144
First Posted: August 27, 2015    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018
Last Verified: September 2017
Keywords provided by David Pickham, Stanford University:
Bed Sores
Bedsores
Decubitus Ulcer
Pressure Sore
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases