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

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optimal Turning
Standard Care Practices
Patient Sensor
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Bed Sores, Bedsores, Decubitus Ulcer, Pressure Sore

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment - Optimal Turning

Control - Standard Care

Arm Description

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.).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compliance With Patient Turning Procedures
Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.

Full Information

First Posted
August 17, 2015
Last Updated
September 13, 2017
Sponsor
Stanford University
Collaborators
Leaf Healthcare, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02533726
Brief Title
Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers
Acronym
LS-HAPU
Official Title
Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Leaf Healthcare, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Bed Sores, Bedsores, Decubitus Ulcer, Pressure Sore

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment - Optimal Turning
Arm Type
Experimental
Arm Description
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.).
Arm Title
Control - Standard Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Optimal Turning
Other Intervention Name(s)
Patient Turning, Pressure Ulcer Prevention
Intervention Description
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
Intervention Name(s)
Standard Care Practices
Intervention Description
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
Intervention Name(s)
Patient Sensor
Other Intervention Name(s)
Leaf Healthcare Patient Monitoring Sensor
Intervention Description
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 Outcome Measure Information:
Title
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
Description
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
Time Frame
Duration of ICU admission (average 1 week)
Secondary Outcome Measure Information:
Title
Compliance With Patient Turning Procedures
Description
Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.
Time Frame
Duration of ICU admission (average 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pickham, PhD
Organizational Affiliation
Stanford Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27053145
Citation
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.
Results Reference
derived

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Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

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