Use of a Shear Reduction Surface in Pre-hospital Transport
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Shear Force as as measured by the PREDIA monitor
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers
- •18-70 years old
- •Able to read and write English
- •Height of 6' feet tall or less
- •Weight under 300 lbs.
排除标准
- •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.
研究组 & 干预措施
Standard of Care First, then Liquicell
Subjects were secured on a standard ambulance stretcher, with a shear and pressure sensors attached to the body. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance traveled on a closed driver training course accelerating up to 30 mph and decelerating to a stop 5 times. Shear and pressure measurements were taken during the runs. The HOB was then elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects were asked to rate their comfort at each of the HOB elevations using a 0-10 scale. Following the first set of 15 runs, the course was repeated with the LiquiCell® ASMO.
干预措施: Anti-shear mattress overlay (Device)
Standard of Care First, then Liquicell
Subjects were secured on a standard ambulance stretcher, with a shear and pressure sensors attached to the body. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance traveled on a closed driver training course accelerating up to 30 mph and decelerating to a stop 5 times. Shear and pressure measurements were taken during the runs. The HOB was then elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects were asked to rate their comfort at each of the HOB elevations using a 0-10 scale. Following the first set of 15 runs, the course was repeated with the LiquiCell® ASMO.
干预措施: Standard of Care (Other)
Liquicell First, then Standard of Care
Subjects were 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 body. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance traveled on a closed driver training course accelerating up to 30 mph and decelerating to a stop 5 times. Shear and pressure measurements were taken throughout the runs. The HOB was then elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects were asked to rate their comfort at each of the HOB elevations using a 0-10 scale. Following the first set of 15 runs, the course was repeated without the LiquiCell ASMO.
干预措施: Anti-shear mattress overlay (Device)
Liquicell First, then Standard of Care
Subjects were 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 body. Starting at 0 degrees head-of-bed (HOB) elevation, the ambulance traveled on a closed driver training course accelerating up to 30 mph and decelerating to a stop 5 times. Shear and pressure measurements were taken throughout the runs. The HOB was then elevated to 15 and 30 degrees respectively, and the procedure repeated. Subjects were asked to rate their comfort at each of the HOB elevations using a 0-10 scale. Following the first set of 15 runs, the course was repeated without the LiquiCell ASMO.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change in Shear Force as as measured by the PREDIA monitor
时间窗: 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.
次要结局
- Change in Tissue-Interface Pressure as measured by the PREDIA monitor(baseline, 2 hours)
- Change in Comfort Score(baseline, 2 hours)
研究者
Ann N. Tescher,Ph.D.
Clinical Nurse Specialist
Mayo Clinic