Trial Outcomes & Findings for NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion (NCT NCT03483623)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

0 minutes

Results posted on

2020-03-25

Participant Flow

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

Participant milestones

Participant milestones
Measure	NATO WELP/ NATO FIS / RAVEN WELP / RAVEN FIS 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.
Overall Study STARTED	44
Overall Study Started NATO WELP	44
Overall Study Completeded NATO WELP	43
Overall Study Started NATO FIS	44
Overall Study Completed NATO FIS	43
Overall Study Started RAVEN WELP	44
Overall Study Completed RAVEN WELP	43
Overall Study Started RAVEN FIS	44
Overall Study Completed RAVEN FIS	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	NATO WELP/ NATO FIS / RAVEN WELP / RAVEN FIS 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.
Overall Study 43 complete sets achieved	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants
Race/Ethnicity, Customized African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Native American/Pacific Islander	3 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial/Other	2 Participants n=5 Participants
Region of Enrollment United States	43 Participants n=5 Participants
BMI <18.5	1 Participants n=5 Participants
BMI 18.5 - 24.9	21 Participants n=5 Participants
BMI >25	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Peak Pressure Index NATO WELP	320.63 mm Hg Standard Deviation 23.46222
Pressure Redistribution: Peak Pressure Index NATO FIS	264.8107 mm Hg Standard Deviation 18.91339
Pressure Redistribution: Peak Pressure Index RAVEN WELP	328.5933 mm Hg Standard Deviation 22.8568
Pressure Redistribution: Peak Pressure Index RAVEN FIS	267.1014 mm Hg Standard Deviation 19.66037

PRIMARY outcome

Timeframe: 5 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 5 minutes. PPI will be measured in mm Hg and the mean will be reported

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Peak Pressure Index NATO WELP	312.0279 mm Hg Standard Deviation 23.41317
Pressure Redistribution: Peak Pressure Index NATO FIS	255.1633 mm Hg Standard Deviation 17.11509
Pressure Redistribution: Peak Pressure Index RAVEN WELP	318.78 mm Hg Standard Deviation 26.95208
Pressure Redistribution: Peak Pressure Index RAVEN FIS	257.0823 mm Hg Standard Deviation 18.12933

PRIMARY outcome

Timeframe: 10 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 10 minutes. PPI will be measured in mm Hg and the mean will be reported

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Peak Pressure Index NATO WELP	306.5656 mm Hg Standard Deviation 22.72959
Pressure Redistribution: Peak Pressure Index NATO FIS	251.1965 mm Hg Standard Deviation 17.01875
Pressure Redistribution: Peak Pressure Index RAVEN WELP	312.2267 mm Hg Standard Deviation 25.76947
Pressure Redistribution: Peak Pressure Index RAVEN FIS	252.4823 mm Hg Standard Deviation 17.06234

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Peak Pressure Index NATO FIS	247.7028 mm Hg Standard Deviation 15.50624
Pressure Redistribution: Peak Pressure Index RAVEN WELP	311.5874 mm Hg Standard Deviation 24.86347
Pressure Redistribution: Peak Pressure Index RAVEN FIS	248.243 mm Hg Standard Deviation 15.88815
Pressure Redistribution: Peak Pressure Index NATO WELP	304.9372 mm Hg Standard Deviation 23.06759

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO WELP	778.5449 cm2 Standard Deviation 198.1991
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO FIS	610.3898 cm2 Standard Deviation 218.4296
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN WELP	778.5819 cm2 Standard Deviation 195.4681
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN FIS	589.0567 cm2 Standard Deviation 229.7783

PRIMARY outcome

Timeframe: 5 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 5 minutes. This measure will be expressed as cm2 and the mean will be reported

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO WELP	693.3249 cm2 Standard Deviation 180.7349
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO FIS	501.3781 cm2 Standard Deviation 198.9074
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN WELP	693.353 cm2 Standard Deviation 179.1237
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN FIS	488.0037 cm2 Standard Deviation 205.4465

PRIMARY outcome

Timeframe: 10 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 10 minutes. This measure will be expressed as cm2 and the mean will be reported

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO WELP	648.0126 cm2 Standard Deviation 180.7803
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO FIS	435.3356 cm2 Standard Deviation 183.7115
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN WELP	648.0142 cm2 Standard Deviation 169.5882
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN FIS	432.2805 cm2 Standard Deviation 192.3748

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	North Atlantic Treaty Organization (NATO) and Warrior Evacuati n=43 Participants 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
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO WELP	618.6412 cm2 Standard Deviation 173.1517
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg NATO FIS	397.21 cm2 Standard Deviation 170.7791
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN WELP	619.6928 cm2 Standard Deviation 171.8377
Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg RAVEN FIS	373.2549 cm2 Standard Deviation 173.9249

Adverse Events

North Atlantic Treaty Organization (NATO) and Warrior Evacuati

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lt Col Laurie Migliore

David Grant Medical Center, Clinical Investigation Facility, Travis AFB, CA

Phone: 707-423-7280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place