Shear Strength Clinical Trial
Official title:
Use of a Shear Reduction Surface in Pre-hospital Transport
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.
This study enrolled healthy adult volunteers of any race or gender, stratified into 3 Body
Mass Index (BMI) categories (≤20, 20.1-24.9, ≥25), who served as their own controls. The
setting for this study was on a closed driving course utilized for training of emergency and
law enforcement personnel, and the vehicle used was 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) was placed on the standard
ambulance stretcher mattress. Shear force and tissue interface pressure was measured during
a full stop, acceleration, travelling at 30 mph, deceleration, and a full stop by a PREDIA
device (Molten Corporation, Hiroshima Japan) through reusable sensors attached to the
sacrum, ischial tuberosity, and heel.
Procedures: Following written informed consent, subjects were weighed and measured with a
calibrated scale to calculate a current BMI. Three PREDIA sensors were secured to three
sites (sacrum, ischial tuberosity, and heel) with double-stick tape. Subjects wore standard
hospital scrub bottoms, and were secured supine to the ambulance stretcher using standard
procedure. Subjects were blinded to the presence of the LiquiCell® ASMO overlay by a sheet
covering on the stretcher. The ASMO was placed according to a simple randomization table.
The stretcher was initially be placed with 0 degree head-of-bed (HOB) elevation, followed by
subsequent HOB elevations of 15 degrees and 30 degrees. HOB elevations were verified using a
standard goniometer. The ambulance traveled over a closed course driven by ambulance staff
members that had passed the mandatory Coaching the Emergency Vehicle Operator (CEVO) driving
course. The course included at maximum speed of 30 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 were taken with the PREDIA sensors
during a full stop, acceleration, travelling at 30 mph, deceleration, and a full stop for
each "run". At the beginning and completion of each set of 5 runs, subjects were asked to
rate their discomfort on a scale of 0 (no discomfort) to 10 (worst discomfort imaginable).
Following the first set of 15 runs, the course was repeated with or without the LiquiCell®
ASMO according to the randomization table.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05812456 -
Comparison Between Shear Bond Strength of Different Commercial Metal Bracket Brands: an in Vitro Study
|
N/A |