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

Tissue Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483623
• Other study ID #: FDG20160005H
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: March 2020
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	David Grant Medical Center	Travis Air Force Base	California

Sponsors (1)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bale S, Finlay I, Harding KG. Pressure sore prevention in a hospice. J Wound Care. 1995 Nov;4(10):465-8. — View Citation

Bridges EJ, Schmelz JO, Mazer S. Skin interface pressure on the NATO litter. Mil Med. 2003 Apr;168(4):280-6. — View 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. — View 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. — View 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. Review. — View Citation

International review. Pressure ulcer prevention: pressure, shear, friction and microclimate in context. A consensus document. London: Wounds International, 2010

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	0 minutes
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 5 minutes. PPI will be measured in mm Hg and the mean will be reported	5 minutes
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 10 minutes. PPI will be measured in mm Hg and the mean will be reported	10 minutes
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 15 minutes. PPI will be measured in mm Hg and the mean will be reported	15 minutes
Primary	Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg	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	0 minutes
Primary	Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg	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	5 minutes
Primary	Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg	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	10 minutes
Primary	Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg	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	15 minutes

External Links

•   Advanced surface technology for positive patient outcomes
•   PeriFlux System 5000 (instrument version 1.70-1.79) Extended User Manual
•   Pressure effects from a military stretcher. J R Army Med Corps
•   Pressure Ulcer Risk Assessment and Prevention: Comparative Effectiveness. Comparative
•   Strykers' Pioneer (TM) pressure redistributing stretcher surface is the ?rst of its kind for emergency departments