Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

NCT02533726 | Completed Results

• 1 other identifier: 33144
• Study Type: interventional
• Target: 1,312
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

Bed Sores; Bedsores; Decubitus Ulcer; Pressure Sore

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compliance With Patient Turning Procedures

  Duration of ICU admission (average 1 week)

Study Arms (2)

Treatment - Optimal Turning

EXPERIMENTAL

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; Other: Patient Sensor

Control - Standard Care

ACTIVE COMPARATOR

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; Other: Patient Sensor

Interventions

Optimal Turning 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.

Also known as: Patient Turning, Pressure Ulcer Prevention

Treatment - Optimal Turning

Standard Care Practices 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.

Control - Standard Care

Patient Sensor 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.

Also known as: Leaf Healthcare Patient Monitoring Sensor

Control - Standard Care; Treatment - Optimal Turning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>18 years of age)
• Admission to Intensive Care Unit

You may not qualify if:

• Children (\<18 years of age)
• Adhesive allergy
• Physical limitation for sensor application

Sponsors & Collaborators

• Stanford University: lead
• Leaf Healthcare, Inc.: collaborator

Study Sites (1)

Stanford Health Care

Stanford, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 27053145 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr David Pickham
• Organization: Stanford University School of Medicine

dpickham@stanford.edu

650 701 6830

Study Officials

• David Pickham, PhD

  Stanford Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2017-09

Locations

US (1)