Clinical trial NCT03483623: NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
Official title: NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Distribution
Military Litters
Peak Pressure Index
Total Surface Area
Tissue Perfusion
Keywords: NATO Litter
Dolphin Fluid Immersion System
Raven 90C litter
Transcutaneous oxygenation
WELP mattress
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2018-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pressure Redistribution: Peak Pressure Index
timeFrame: 0 minutes
measure: Pressure Redistribution: Peak Pressure Index
timeFrame: 5 minutes
measure: Pressure Redistribution: Peak Pressure Index
timeFrame: 10 minutes
measure: Pressure Redistribution: Peak Pressure Index
timeFrame: 15 minutes
measure: Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg
timeFrame: 0 minutes
measure: Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg
timeFrame: 5 minutes
measure: Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg
timeFrame: 10 minutes
measure: Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
Study officials:
affiliation: David Grant Medical Center
name: Laurie Migliore, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 59th Medical Wing
name: Antoinette Shinn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bale S, Finlay I, Harding KG. Pressure sore prevention in a hospice. J Wound Care. 1995 Nov;4(10):465-8. doi: 10.12968/jowc.1995.4.10.465.
citation: Bridges EJ, Schmelz JO, Mazer S. Skin interface pressure on the NATO litter. Mil Med. 2003 Apr;168(4):280-6.
citation: Hanson DS, Langemo D, Anderson J, Thompson P, Hunter S. Can pressure mapping prevent ulcers? Nursing. 2009 Jun;39(6):50-1. doi: 10.1097/01.NURSE.0000352337.67771.e0. No abstract available.
citation: International review. Pressure ulcer prevention: pressure, shear, friction and microclimate in context. A consensus document. London: Wounds International, 2010
citation: Hatzfeld JJ, Dukes S, Bridges E. Chapter 3 innovations in the en route care of combat casualties. Annu Rev Nurs Res. 2014;32:41-62. doi: 10.1891/0739-6686.32.41.
citation: Harada C, Shigematsu T, Hagisawa S. The effect of 10-degree leg elevation and 30-degree head elevation on body displacement and sacral interface pressures over a 2-hour period. J Wound Ostomy Continence Nurs. 2002 May;29(3):143-8. doi: 10.1067/mjw.2002.123645.
citation: Junkin J, Gray M. Are pressure redistribution surfaces or heel protection devices effective for preventing heel pressure ulcers? J Wound Ostomy Continence Nurs. 2009 Nov-Dec;36(6):602-8. doi: 10.1097/WON.0b013e3181be282f.