N/A
Completed N=44
NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
Pressure Distribution · Military Litters · Peak Pressure Index · Total Surface Area
Source: ClinicalTrials.gov NCT03483623 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Pressure Redistribution: Peak Pressure Index — 320.63; 264.8107; 328.5933; 267.1014 mm Hg — p=0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pressure Redistribution: Peak Pressure Index |
304.9372; 247.7028; 311.5874; 248.243 | 0.0001 sig |
| PRIMARY Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg |
618.6412; 397.21; 619.6928; 373.2549 | 0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT03483623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.