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Completed

NCT Number: NCT02591641

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-shear mattress overlay

Device

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

Other names: LiquiCell

Standard of care

Other

Standard ambulance stretcher mattress

Primary outcomes

  1. Change in Shear Force as as measured by the PREDIA monitor

    Time frame: baseline, 2 hours

    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.

Secondary outcomes

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

    Time frame: baseline, 2 hours

    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.

  2. Change in Comfort Score

    Time frame: baseline, 2 hours

    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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2015
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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