NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
NCT ID: NCT03483623
Last Updated: 2020-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2018-03-21
2018-10-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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NATO WELP combination
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
NATO 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.
NATO FIS combination
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
NATO FIS 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.
RAVEN WELP combination
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
RAVEN 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.
RAVEN FIS combination
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
RAVEN FIS 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.
Interventions
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NATO 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.
NATO FIS 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.
RAVEN 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.
RAVEN FIS 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
ALL
Yes
Sponsors
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David Grant U.S. Air Force Medical Center
FED
Responsible Party
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Laurie Migliore
Chief, Nursing Research
Principal Investigators
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Laurie Migliore, PhD
Role: PRINCIPAL_INVESTIGATOR
David Grant Medical Center
Antoinette Shinn, PhD
Role: PRINCIPAL_INVESTIGATOR
59th Medical Wing
Locations
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David Grant Medical Center
Travis Air Force Base, California, United States
Countries
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References
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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.
Bridges EJ, Schmelz JO, Mazer S. Skin interface pressure on the NATO litter. Mil Med. 2003 Apr;168(4):280-6.
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.
International review. Pressure ulcer prevention: pressure, shear, friction and microclimate in context. A consensus document. London: Wounds International, 2010
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Strykers' Pioneer (TM) pressure redistributing stretcher surface is the first of its kind for emergency departments
PeriFlux System 5000 (instrument version 1.70-1.79) Extended User Manual
Pressure effects from a military stretcher. J R Army Med Corps
Other Identifiers
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FDG20160005H
Identifier Type: -
Identifier Source: org_study_id
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