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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To determine the difference in the pressure redistribution qualities of the WELP when used as the mattress on the NATO litter and Raven litter. 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.

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

Conditions
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Pressure Distribution, Military Litters, Peak Pressure Index, Total Surface Area, Tissue Perfusion

Intervention / Treatment
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* Other: NATO WELP combination
* Other: NATO FIS combination
* Other: RAVEN WELP combination
* Other: RAVEN FIS combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over the age of 18 years with lawful access to Travis Air Force Base (AFB) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This protocol is a Quasi Experimental Cross Factor study. The subject sample is nonrandomized. Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels on four different surface combinations.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NATO WELP combination<br>Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels and interface pressures on NATO litter and WELP mattress combination | Other: NATO WELP combination<br>* Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.<br>|
| Experimental: NATO FIS combination<br>Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels and interface pressures on NATO litter and Fluid Immersion System (FIS) mattress combination | Other: NATO FIS combination<br>* Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.<br>|
| Experimental: RAVEN WELP combination<br>Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels and interface pressures on Raven 90C litter and WELP mattress combination | Other: RAVEN WELP combination<br>* Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.<br>|
| Experimental: RAVEN FIS combination<br>Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels and interface pressures on Raven 90C litter and Fluid Immersion System (FIS) mattress combination | Other: RAVEN FIS combination<br>* Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Redistribution: Peak Pressure Index | 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 0 minutes. PPI will be measured in mm Hg and the mean will be reported | 0 minutes | 
| Pressure Redistribution: Peak Pressure Index | 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 5 minutes. PPI will be measured in mm Hg and the mean will be reported | 5 minutes | 
| Pressure Redistribution: Peak Pressure Index | 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 10 minutes. PPI will be measured in mm Hg and the mean will be reported | 10 minutes | 
| Pressure Redistribution: Peak Pressure Index | 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 | 15 minutes | 
| Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg | 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 0 minutes. This measure will be expressed as cm2 and the mean will be reported | 0 minutes | 
| Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg | 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 5 minutes. This measure will be expressed as cm2 and the mean will be reported | 5 minutes | 
| Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg | 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 10 minutes. This measure will be expressed as cm2 and the mean will be reported | 10 minutes | 
| Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg | 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 | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WELP mattress, NATO Litter, Dolphin Fluid Immersion System, Raven 90C litter, Transcutaneous oxygenation