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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03483623

Enrollment

Registered

2018-03-30

Start date

2018-03-21

Completion date

2018-10-19

Last updated

2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

NATO Litter, Dolphin Fluid Immersion System, Raven 90C litter, Transcutaneous oxygenation, WELP mattress

Brief summary

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.

Interventions

OTHERNATO WELP combination

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.

OTHERNATO FIS combination

OTHERRAVEN WELP combination

OTHERRAVEN FIS combination

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Participant flow

Pre-assignment details

North Atlantic Treaty Organization (NATO) and Warrior Evacuation Litter Pad (WELP); NATO and Fluid Immersion System (FIS) mattress; Raven 90C litter and WELP; Raven 90C and FIS

Participants by arm

Arm	Count
North Atlantic Treaty Organization (NATO) and Warrior Evacuati Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels, laser Doppler pressure units, and interface pressures on NATO / Raven litters and WELP / FIS mattress combinations. Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers and probes 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 and Doppler 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	43
Total	43

Arm

Count

North Atlantic Treaty Organization (NATO) and Warrior Evacuati

Subjects will be their own control and have repeated measurements to compare baseline and supine transcutaneous oxygenation levels, laser Doppler pressure units, and interface pressures on NATO / Raven litters and WELP / FIS mattress combinations. Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers and probes 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 and Doppler 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

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	43 complete sets achieved	1

Baseline characteristics

Characteristic	North Atlantic Treaty Organization (NATO) and Warrior Evacuati
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	43 Participants
BMI <18.5	1 Participants
BMI 18.5 - 24.9	21 Participants
BMI >25	21 Participants
Race/Ethnicity, Customized African American	8 Participants
Race/Ethnicity, Customized Asian	3 Participants
Race/Ethnicity, Customized Hispanic/Latino	8 Participants
Race/Ethnicity, Customized Multiracial/Other	2 Participants
Race/Ethnicity, Customized Native American/Pacific Islander	3 Participants
Race/Ethnicity, Customized White	19 Participants
Region of Enrollment United States	43 Participants
Sex: Female, Male Female	27 Participants
Sex: Female, Male Male	16 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 43
other Total, other adverse events	0 / 43
serious Total, serious adverse events	0 / 43

Outcome results

Primary

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

Time frame: 0 minutes

Arm	Measure	Group	Value (MEAN)	Dispersion
North Atlantic Treaty Organization (NATO) and Warrior Evacuati	Pressure Redistribution: Peak Pressure Index	NATO WELP	320.63 mm Hg	Standard Deviation 23.46222
North Atlantic Treaty Organization (NATO) and Warrior Evacuati	Pressure Redistribution: Peak Pressure Index	NATO FIS	264.8107 mm Hg	Standard Deviation 18.91339
North Atlantic Treaty Organization (NATO) and Warrior Evacuati	Pressure Redistribution: Peak Pressure Index	RAVEN WELP	328.5933 mm Hg	Standard Deviation 22.8568
North Atlantic Treaty Organization (NATO) and Warrior Evacuati	Pressure Redistribution: Peak Pressure Index	RAVEN FIS	267.1014 mm Hg	Standard Deviation 19.66037