Use of a Shear Reduction Surface in Pre-hospital Transport

NCT02591641 | Completed

• 1 other identifier: 15-004912
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to examine the effectiveness of a shear reduction surface on shear, pressure, and comfort used in pre-hospital ground transport.

Conditions

Shear Strength

Keywords

pre-hospital transport; shear force; tissue interface pressure

Outcome Measures

Primary Outcomes (1)

• Change in Shear Force as as measured by the PREDIA monitor

  The PREDIA monitor is a hand-held monitor that measures both shear forced (measured in Newtons) and tissue-interface pressure (measured in mmHg) simultaneously at discrete points in time.

  baseline, 2 hours

Secondary Outcomes (2)

• Change in Tissue-Interface Pressure as measured by the PREDIA monitor

  baseline, 2 hours

• Change in Comfort Score

  baseline, 2 hours

Study Arms (2)

Standard of Care First, then Liquicell

EXPERIMENTAL

Subjects were secured on a standard ambulance stretcher, with a shear and pressure sensors attached to the body. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance traveled on a closed driver training course accelerating up to 30 mph and decelerating to a stop 5 times. Shear and pressure measurements were taken during the runs. The HOB was then elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects were asked to rate their comfort at each of the HOB elevations using a 0-10 scale. Following the first set of 15 runs, the course was repeated with the LiquiCell® ASMO.

Device: Anti-shear mattress overlay; Other: Standard of Care

Liquicell First, then Standard of Care

EXPERIMENTAL

Subjects were secured on a standard ambulance stretcher with an anti-shear mattress overlay placed on top of the stretcher, with a shear and pressure sensor attached to the body. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance traveled on a closed driver training course accelerating up to 30 mph and decelerating to a stop 5 times. Shear and pressure measurements were taken throughout the runs. The HOB was then elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects were asked to rate their comfort at each of the HOB elevations using a 0-10 scale. Following the first set of 15 runs, the course was repeated without the LiquiCell ASMO.

Device: Anti-shear mattress overlay; Other: Standard of Care

Interventions

Anti-shear mattress overlay DEVICE

A commercial full-length LiquiCell® anti-shear mattress overlay (ASMO) was placed on the standard ambulance stretcher mattress.

Also known as: LiquiCell

Liquicell First, then Standard of Care; Standard of Care First, then Liquicell

Standard of Care OTHER

Standard ambulance stretcher mattress

Liquicell First, then Standard of Care; Standard of Care First, then Liquicell

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers
• years old
• Able to read and write English
• Height of 6' feet tall or less
• Weight under 300 lbs.

You may not qualify if:

• Non-English speaking
• Pregnancy
• Prisoners
• Previous history of pelvic fracture, pressure ulcers on sacrum, ischial tuberosity, or heel
• Adhesive allergy or sensitivity
• Height over 6 feet tall
• Weight over 300 lbs.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ann Tescher, APRN, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)