Clinical trial NCT02591641: Use of a Shear Reduction Surface in Pre-hospital Transport
Official title: Use of a Shear Reduction Surface in Pre-hospital Transport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shear Strength
Keywords: pre-hospital transport
shear force
tissue interface pressure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Shear Force as as measured by the PREDIA monitor
timeFrame: baseline, 2 hours
Secondary outcomes:
measure: Change in Tissue-Interface Pressure as measured by the PREDIA monitor
timeFrame: baseline, 2 hours
measure: Change in Comfort Score
timeFrame: baseline, 2 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ann Tescher, APRN, PhD
role: PRINCIPAL_INVESTIGATOR
References: