跳至主要内容
临床试验/NCT03483623
NCT03483623已完成不适用

NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion

David Grant U.S. Air Force Medical Center2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Pressure Redistribution: Peak Pressure Index

研究概览

简要总结

The purpose of this study is to measure peak skin interface pressures and the total area of the body exposed to skin interface pressure above 30 mm Hg at different areas of the body in the supine position on two different support surfaces applied to a standard North Atlantic Treaty Organization (NATO) litter (NSN: 6530-01-380-7309) and a Raven 90C Litter (NSN6530-01-432-5114). The support surfaces are the Warrior Evacuation Litter Pad (WELP) and the Dolphin Fluid Immersion Simulation Stretcher System (FIS). These pressure measurements and transcutaneous oxygenation readings will allow us to determine differences between support surfaces.

详细描述

The purpose of this study is to measure peak skin interface pressures and the total area of the body exposed to skin interface pressure above 30 mm Hg at different areas of the body in the supine position on two different support surfaces applied to a standard North Atlantic Treaty Organization (NATO) litter (NSN: 6530-01-380-7309) and a Raven 90C Litter (NSN6530-01-432-5114). The Raven 90C is the official litter for the U.S. Navy. It is approved for flight on United States Air Force (USAF) aircraft. It can be easily folded for storage and transport to remote settings. The support surfaces are the Warrior Evacuation Litter Pad (WELP) and the Dolphin Fluid Immersion Simulation Stretcher System (FIS). In theory, mattresses that reduce and/or minimize pressure on the capillary bed's perfusion can help reduce pressure related injury such as pressure or decubitus ulcer development. Skin interface pressure measurements using a pressure mapping system and transcutaneous oxygenation readings will allow us to determine these differences between support surfaces. A better understanding of skin interface pressure associated with the litter support surfaces is vital for military nurses to develop and implement preventative interventions to reduce pressure ulcer development in our patients. In addition, this study will provide information to help determine the usefulness and feasibility of incorporating the fluid immersion system (FIS) as a litter support surface.

This research protocol has one major aim:

To determine the difference in the pressure redistribution qualities between the WELP and the Dolphin FIS

There are also two secondary aims:

  1. To determine the difference in the pressure redistribution qualities of the WELP when used as the mattress on the NATO litter and Raven litter.
  2. To determine the difference in the pressure redistribution qualities of the Dolphin FIS when used as the mattress on the NATO litter and Raven litter.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over the age of 18 years with lawful access to Travis Air Force Base (AFB)

排除标准

  • Orthopedic or neurological conditions that prevent a subject from lying flat (supine) without any pillows for head, neck, or lumbar support
  • Medical conditions (such as an uncontrollable tremor or twitch) that prevent a subject from staying still for the required periods of time (20 minute increments).
  • Pregnancy
  • Inability to ambulate unassisted, unstable gate (presenting increased fall risk)
  • Extremity prosthetics (hand/arm or foot/leg)
  • Height greater than 72 inches (6 feet) - exceeds length of the litter & mattress surfaces
  • Body weight greater than 300 lbs
  • Subjects who find it difficult, uncomfortable or impossible to remain still for the necessary study time durations (20 minute increments) on the relatively narrow litter surfaces will be removed from the study.
  • Subject does not speak or understand the English language

结局指标

主要结局

Pressure Redistribution: Peak Pressure Index

时间窗: 15 minutes

Determine the difference in the pressure redistribution qualities between the WELP and the Dolphin FIS when used as mattress on the NATO litter and Raven litter. Pressure redistribution qualities will be measured in mmHg using XSensor X3 pressure mapping technology. To minimize the risk of a faulty sensor or false reading over one sensor, the average of eight cells around the region will be recorded and referred to as the Peak Pressure Index (PPI). Peak interface pressure is the highest average pressure (mm Hg) measured over vulnerable bony prominences (occiput, sacrum, and bilateral scapula, buttocks, and heels) at 15 minutes. PPI will be measured in mm Hg and the mean will be reported

Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg

时间窗: 15 minutes

Determine the difference in the pressure redistribution qualities between the WELP when used on the NATO litter and Raven litter. Pressure redistribution will be measured over vulnerable bony prominences as total area of body exposed to skin interface pressures exceeding 30 mm Hg while subjects are in the supine position at 15 minutes. This measure will be expressed as cm2 and the mean will be reported

次要结局

未报告次要终点

研究者

发起方
David Grant U.S. Air Force Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Laurie Migliore

Chief, Nursing Research

David Grant U.S. Air Force Medical Center

研究点 (2)

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