Overview

This trial is active, not recruiting.

Condition shear strength
Treatments anti-shear mattress overlay, no intervention standard of care
Sponsor Mayo Clinic
Start date November 2015
End date May 2016
Trial size 30 participants
Trial identifier NCT02591641, 15-004912

Summary

Does the use of an anti-shear mattress overlay placed on a pre-hospital transport stretcher reduce shear forces and pressure on the skin, and increase patient comfort as compared to standard care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Other)
Subjects will be secured on a standard ambulance stretcher, with a shear and pressure sensor attached to the sacrum, ischial tuberosity, and heel. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance will travel on a closed driver training course accelerating up to 40 mph and decelerating to a stop 5 times. Shear and pressure measurements will be taken during the runs. The HOB will then be elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects will be asked to rate their comfort at each of the HOB elevations using a 0-10 scale.
no intervention standard of care
(Experimental)
Subjects will be 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 sacrum, ischial tuberosity, and heel. Subjects will be blinded to the presence of the overlay. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance will travel on a closed driver training course accelerating up to 40 mph and decelerating to a stop 5 times. Shear and pressure measurements will be taken throughout the runs. The HOB will then be elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects will be asked to rate their comfort at each of the HOB elevations using a 0-10 scale.
anti-shear mattress overlay LiquiCell

Primary Outcomes

Measure
Change in Shear Force as as measured by the PREDIA monitor
time frame: baseline, 2 hours
Change in Tissue-Interface Pressure as measured by the PREDIA monitor
time frame: baseline, 2 hours

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion criteria: - Healthy adult volunteers - 18-70 years old - Able to read and write English - Height of 6' feet tall or less - Weight under 300 lbs. Exclusion criteria: - 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.

Additional Information

Official title Use of a Shear Reduction Surface in Pre-hospital Transport
Principal investigator Ann Tescher, APRN, PhD
Description This study will enroll 30 healthy adult volunteers of any race or gender, stratified into 3 Body Mass Index (BMI) categories (≤20, 20.1-24.9, ≥25), who will serve as their own controls. The setting for this study will be on a closed driving course utilized for training of emergency and law enforcement personnel, and the vehicle used will be a standard ground ambulance affiliated with the Medical Transport of a tertiary medical center. Apparatus and/or instruments: A commercial full-length LiquiCell® anti-shear mattress overlay (ASMO) (Birchwood Laboratories, Eden Prairie MN) (http://liquicell.com) will be placed on the standard ambulance stretcher mattress. Shear force and tissue interface pressure will be measured during deceleration by a PREDIA device (Molten Corporation, Hiroshima Japan) through reusable sensors attached to the sacrum, ischial tuberosity, and heel. Limitations: Since this study will be conducted using adult healthy volunteers in a ground ambulance, the findings may not be generalizable to children, those with skin at risk for pressure related injury, air medical transport, or to other types of ambulance stretchers. Procedures: Following written informed consent, subjects will be weighed and measured with a calibrated scale to calculate a current BMI. Three PREDIA sensors will be secured to three sites (sacrum, ischial tuberosity, and heel) with double-stick tape. Subjects will wear standard hospital scrub bottoms, and be secured supine to the ambulance stretcher using standard procedure. Subjects will be blinded to the presence of the LiquiCell® ASMO overlay by a sheet covering on the stretcher. The ASMO will be placed according to a simple randomization table. The stretcher will initially be placed with 0 degree head-of-bed (HOB) elevation, followed by subsequent HOB elevations of 15 degrees and 30 degrees. HOB elevations will be verified using a standard goniometer. The ambulance will travel over a closed course driven by ambulance staff members that have passed the mandatory Coaching the Emergency Vehicle Operator (CEVO) driving course. The course will include at maximum speed of 40 mph and 5 complete stops at each of 3 HOB elevations (0, 15, and 30 degrees). Shear measurements (measured in Newtons) and pressure measurements (measured in mmHg) for each anatomical site will be taken with the PREDIA sensors during deceleration for each stop. At the completion of each set of 5 stops, subjects will be asked to rate their discomfort on a scale of 0 (no discomfort) to 10 (worst discomfort imaginable). At the completion of the course, the subject will be allowed to rest outside the ambulance for 15 minutes. Following the rest period, the course will be repeated with or without the LiquiCell® ASMO according to the randomization table.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.