Use of a Shear Reduction Surface in Pre-hospital Transport
This trial is active, not recruiting.
|Treatments||anti-shear mattress overlay, no intervention standard of care|
|Start date||November 2015|
|End date||May 2016|
|Trial size||30 participants|
|Trial identifier||NCT02591641, 15-004912|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
|Primary purpose||supportive care|
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
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.
|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.|
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