Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483623
Recruitment Status : Completed
First Posted : March 30, 2018
Results First Posted : March 11, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Laurie Migliore, David Grant U.S. Air Force Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pressure Distribution Military Litters Peak Pressure Index Total Surface Area Tissue Perfusion Other: NATO WELP combination Other: NATO FIS combination Other: RAVEN WELP combination Other: RAVEN FIS combination Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
Actual Study Start Date : March 21, 2018
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Arm Intervention/treatment
Experimental: 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
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.

Experimental: 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
Other: 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.

Experimental: 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
Other: 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.

Experimental: 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
Other: 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.




Primary Outcome Measures :
  1. Pressure Redistribution: Peak Pressure Index [ Time Frame: 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

  2. Pressure Redistribution: Peak Pressure Index [ Time Frame: 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

  3. Pressure Redistribution: Peak Pressure Index [ Time Frame: 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

  4. Pressure Redistribution: Peak Pressure Index [ Time Frame: 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

  5. Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg [ Time Frame: 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

  6. Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg [ Time Frame: 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

  7. Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg [ Time Frame: 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

  8. Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483623


Locations
Layout table for location information
United States, California
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Laurie Migliore, PhD David Grant Medical Center
Principal Investigator: Antoinette Shinn, PhD 59th Medical Wing
  Study Documents (Full-Text)

Documents provided by Laurie Migliore, David Grant U.S. Air Force Medical Center:

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Laurie Migliore, Chief, Nursing Research, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT03483623    
Other Study ID Numbers: FDG20160005H
First Posted: March 30, 2018    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurie Migliore, David Grant U.S. Air Force Medical Center:
NATO Litter
Dolphin Fluid Immersion System
Raven 90C litter
Transcutaneous oxygenation
WELP mattress