NATO Litter: Fluid Immersion System (FIS) Versus Traditional Mattress for Pressure Dispersion
Phase: NA
Conditions: Pressure Distribution, Military Litters, Peak Pressure Index, Total Surface Area, Tissue Perfusion
Sponsor: David Grant U.S. Air Force Medical Center

For Protocol Office use only: 
(investigator names redacted 23 Jan 20) 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
DGMC Human Research Protocol 
PROPOSAL FOR HUMAN RESEARCH 
CLINICAL INVESTIGATION FACILITY 
60th Medical Group (AMC) 
David Grant USAF Medical Center 
101 Bodin Circle 
Travis AFB, CA 94535-1800 
FWA00003321, DOD 50004, IRB000011217 
Expol 
APPROVED 
ocr-'2 a 2019
60MDG IRB 
TRAVIS AFB CA 
For assistance, call the Chief, Research Oversight and Compliance at (707) 423-7206 
1. Title of Investigation:
NATO Litter: Fluid Immersion System (FIS) versus Traditional Mattress for Pressure Dispersion
2. Investigator and Investigation Staff:
Date of 
Staff/ 
Dept/ 
DoD 
Name 
Rank 
Study 
Investigator 
Resident/ 
Office 
Phone 
Assurance 
E-mail
Role 
Training 
Fellow 
Symbol 
Number 
59 
Col 
PI 
13 Jul 17 
Staff 
MDW/S 
50004 
T 
Lt 
Col 
Co-PI 
29 Jan 19 
Staff 
SGSE 
CTR 
CRN 
19 Jun 17 
CTR 
SGSE 
CTR 
CRN 
l Nov 17 
CTR 
SGSE 
•
The PI must complete an Institutional Review Board (IRB) approved investigator
training course prior to submitting the study.
•
All Als, Cis and SCs must complete investigator training prior to the study receiving
final approval.
•
Only qualified, !RB-approved investigators and study coordinators may perform,
administer, and countersign/witness informed consent.
Research Monitor (RM): NIA this is not a greater than minimal risk study. All procedures are 
non-invasive and no medication/drug use is involved. All equipment used is commercially 
available and FDA approved as required. 
3. Facility and/or Contractor:
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50004 
50004 
50004 
Contact information redacted 23 Jan 20

For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS} versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
All subject enrollment, data collection and data analysis will be conducted at David Grant USAF 
Medi'cal:Center, Travis Air Force Base, California. 
4.· Purp/e. (tfi Investigation:
:Clearing'.tfie battlefield quickly and providing the best care possible for the wounded is a
priorify·.for·milliary medics. The primary mode of patient transport whether by land, sea or air is 
on a litter (NA TO litter for USAF aircraft) 3··7• Litter stands provide the support necessary to
transform a litter into an operating room (OR) table or hospital bed. Patients can spend several 
hours and/or days resting on a litter in a field hospital, or in transit to the next level of care 6-7•
Injuries or illness that prevents patients from normal movement and repositioning place them at 
increased risk of pressure ulcer development 8• Specialty beds and mattresses are available in 
most liospitals to help prevent pressure ulcer development in patients. Unfortunately, these 
products are not currently available for contingency or aeromedical evacuation (AE) operations. 
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
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 along with 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.
5. Category of Study and Risk Assessment:
5.1. Category of Study: 
D Medical Utilization IZ! Prevention D Medical Readiness D Diagnosis/freatment/Other 
5.2. Proposed Risk: 
IZ! Minimal Risk 
D Greater Than Minimal Risk 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
6. Proposed Research:
6.1. Background and Review of Literature:
Background 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
Each year, 2.5 million people in the United States (U.S.) develop pressure ulcers 1• 11,
while approximately 60,000 die of pressure ulcer (PU) related complications each year 9•
The Centers for Medicare & Medicaid estimate that each pressure ulcer adds $43,000. in 
costs to a hospital stay 26• 31, as much as $70,000 for management of a single full 
thickness pressure ulcer, and an annual financial burden estimate of $11 billion per year 
25• Medicare considers Stage III and IV pressure ulcers a health care-associated condition
and will not pay for the additional treatment of patients who acquire them in the hospital
9• The incidence of pressure ulcers has increased in combat casualties returning from
Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) from 2003 to the
present 7• Inter-theater patient movement can have injured and or/ill patients resting on
litters for >8 to 10 hours 6• Research conducted by Lt Col Susan Dukes using the Joint
Theater Trauma Registry (JTTR) from 2008-2012 found 164 patients developed pressure
ulcers (PU) within three days after enroute care (ERC) transport and 142 (87%) were
Critical Care Air Transport Team (CCA TT) patients 43• The number of CCA TT patients
with PUs was only 5% of the total number of patients transported; however, it was still
relatively close to the 7% of hospital acquired pressure ulcers reported for acute care
facilities in the U. S. 6• 24• Prevention of hospital-acquired pressure ulcers (HAPU) is a
nursing quality outcome measure used to evaluate the effectiveness of nursing care and
optimal patient outcomes 
1•7•9•10•11•18• 23• 28•30• In October 2008, the Centers for Medicare &
Medicaid Services added prevention of HAPU to the National Patient Safety Initiatives
31• Preventing HAPU is also a priority for improving the quality care in the current
Healthy People 2020 objectives 26•
Pressure Ulcers 
Pressure ulcers (PU) are defined by the United States National Pressure Ulcer 
Advisory Panel (NPUAP) and the European Pressure Ulcer Advisory Panel (EPUAP) as 
"localized injury to the skin and/or underlying tissue usually over a bony prominence, as 
a result of pressure, or pressure in combination with shear" 8•9• Pressure ulcers develop
when soft tissue is compressed between a bony prominence and a hard surface for an 
extended period of time. In an alert person with normal motor and sensory function, 
nociceptors sense increased pressure and signal the brain. As a result of the signal, the 
person naturally repositions. But if a patient is anesthetized, has a condition that impairs 
their ability to reposition (such as decreased level of consciousness or paralysis), or is 
taking opioids that decrease the pain messages, this protective mechanism is blunted or 
completely disappears raising the risk of pressure ulcer development 9• 18• 3940• While PUs 
can appear in as little as 24 hours, it can take as long as five days before they appear 10•13•
20,35• Prevention of PU development is extremely important as they lead to decreased 
quality of life, increased length of hospital stay, pain, increased morbidity and decreased 
mortality 1• Pressure ulcers are both high cost and high volume adverse events. Although
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System. 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
multiple factors contribute to ulceration such as nutritional status, level of bladder/bowel 
control (continence), physical condition, level of consciousness, immobility, exposure to 
pressure, shear and friction forces, the key factor in tissue damage is unrelieved pressure 
2, 5, 9, 18, 20, 27• Therefore, surfaces that can redistribute pressure across the body are
important 19•
Mattress Surfaces 
In the past, purchasing hospital mattresses was a simple task carried out by 
housekeeping staff or supply custodians. Now with advanced clinical understanding of 
how a mattress can effect skin/wound development and healing, mattress selection has 
increased in importance 14• 17• 19•22• 32•36• The choice of a medical mattress must be made
with a clinical focus on therapy and treatment. A variety of support surfaces are on the 
market. Many manufacturers claim that their product relieves or reduces the external 
forces that contribute to pressure ulcer development. 
Fluid Immersion System (FIS) 
The U.S. Navy trained dolphins for military exercises to use their sophisticated sonar 
abilities. However, the transport of dolphins outside of water subjects them to the vertical 
shear forces of gravity causing internal organ trauma and circulatory distress. An Auto 
Vector surface was created in response to minimize the effects of the gravity's shearing 
forces. Biologics Inc. began development of a Fluid Immersion Simulation (FIS) 
software technology to mimic the fluid buoyancy of a body in salt water. This new 
technology was further developed for medical patients. Joerns Healthcare now offers the 
health care industry hospital beds, operating room tables, stretchers and wheelchairs with 
this FIS technology. Dolphin FIS software uses complex algorithms, a microprocessor 
and sophisticated dynamic pressure waveform analysis to precisely adjust the density of 
the surface for the unique anatomical features of the patient. It is reported to continuously 
monitor the patient's weight, three dimensional (30) surface area and movements to 
automatically calculate the exact settings to effectively manage the pressure of the 
patient's body in the medium. The result is that the patient is truly floating, cradled in a 
simulated fluid environment and suspended in a near neutrally buoyant state (according 
to the manufacturer/product developer). Distortion to the body is minimized and 
orientation of bone, muscle and subcutaneous tissue is normalized (using volumetric 
pressure redistribution). Dolphin FIS technology is easy to use. There's virtually no 
programming, no manual data input, and no need for caregiver/staff intervention. Simply 
plug it into the wall and place the patient on the Auto Vector (mattress) surface. Auto 
Vector "Dolphin" Stretcher Mattress with FIS is customizable to any stretcher regardless 
of make or model 41-42• Therefore, this technology could be designed to fit a NATO litter 
with or without the Special Medical Emergency Evacuation Device (SMEED) commonly 
used to support equipment with critical care aeromedical transport team (CCA TT) 
patients. It also remains inflated up to eight hours with full operation under its own 
internal battery supply. This is a FDA approved commercially available product. 
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Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
A Cochrane systematic review and meta-analysis of studibs focusing on the 
effectiveness of pressure redistribution support surfaces in the prevention of pressure 
ulcers found good evidence that higher specification foam mattresses, sheepskin and 
. some overlays are effective in preventing pressure ulcers. However, the benefits ofhigh­
tech constant low pressure and alternating pressure for pressure ulcer prevention are still 
unclear. Further research is recommended19•
21 •
Limited data exists on blood flow perfusion using the Dolphin FIS technology 32•33•
Kohanzadeh et al. (2009). 33 investigated the effect ·or the FIS stretcher system on the 
body's cutaneous microcirculation using laser doppler flow instrumentation inl O healthy 
subjects on a hospital gurney. Skin perfusion was measured at pressure points of the 
bilateral shoulders of each subject. This technique allowed investigators to monitor the 
dynamic changes in the microcirculation in real time. A significant difference was 
observed in perfusion of 90.52% vs. 22.31 % on a regular gurney mattress and Dolphin 
FIS, respectively. This significant improvement in microcirculation using the Dolphin 
FIS technology when compared to regular gurney foam support mattress may result in 
reduced pressure sores and greater patient comfort. These results are supported from 
observations by Evers et al. (2009)32• Researchers found significantly improved blood 
flow on the Dolphin FIS when compared to the standard gurney/bed despite such 
encouraging results, the studies were small scale with limited sample sizes. Therefore, 
further study with this new FIS technology is recommended 33•
NATO Litter 
Very little literature is published on the use of NATO litters and/or litter padding and 
pressure ulcer development37•38• The interface pressure areas were compared in two 
subjects on the screw and plate strip NA TO litter and tacked canvas NA TO litter (NA TO 
6530-99-138-8737). Both litter versions were evaluated without mattresses. Pressure 
varied greatly on the screw and plate litter than the tacked litter. Pressure was highest 
when the subject's sacrum rested over a ridge on the screw and plate stretcher (138 
mmHg and 104 mmHg) compared with 38 and 43 mmHg on the tacked litter. The authors 
concluded that the tacked litter might possibly be better than the screw and plate version 
38 
In a larger study, investigators explored the differences in skin interface pressures of 
subjects on the NA TO litter (the standard canvas NA TO litter with wooden poles, NSN 
6530-00-783-7905) 3• Thirty-two subjects (18 women/14 men, ages 18-55) underwent 
skin interface pressure measurements on multiple locations over the body (bilateral heels, 
calves, buttocks, scapula, elbows, occiput and sacrum) using the X Sensor pressure 
mapping system. The measurements were taken with subjects on various litter 
configurations: the litter without any padding, with a military wool blanket for padding, 
with the standard aeromedical evacuation (AE) litter pad and with the Baxter Maxifloat 
Mattress. Pressure measurements were taken with the subjects in various physical 
positions (supine, 30° degree lateral position with 0° degree backrest elevation and supine 
with 40° degree backrest elevation) for each litter iteration (with and without the 
padding). There was a significant and progressive decrease in peak pressures between the 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
litter with no padding and the litter with the AE mattress. The greatest pressure decrease 
was found with the Maxifloat mattress. The wool blanket added the least amount of 
pressure reduction (mainly in the region of the buttocks). The AE mattress reduced 
pressures in all areas measures when compared to the litter with no padding and the litter 
with the wool blanket. The Maxifloat mattress reduced pressure areas on an average of 20 
mmHg more than the AE mattress. However, peak pressures over the high risk body 
areas (e.g. occiput, heels and sacrum) were all higher than the critical closing pressure 
(30 mmHg). This finding indicated a potential risk for pressure ulcer development. 
These peak pressures were also higher than those on the Maxifloat mattress. Elevating 
heels, turning or repositioning are recommended for patients at risk for pressure ulcer 
development. Unfortunately on an AE mission with critically injured and/or ventilated 
patient, turning and repositioning may not be possible. The investigators recommended 
further study using litter stanchions, the Raven litter and a mesh decontamination litter. 
They also recommended that transcutaneous oxygenation and blood flow be measured3•
Pressure Mapping 
Pressure mapping systems determine the actual pressure between the body surface and 
the resting platform (mattress, bed, seat cushion, etc.). The mapping system consists of a 
thin, sensor-filled mat with monitoring capabilities placed between the patient and the 
surface he's lying, sitting, or standing on. The sensors convey interface pressures to a 
computer, which produces a color-coded image of the pressure distribution on a computer 
screen. Different colors represent different pressure ranges. Typically, the colors blue and 
green represent lower pressure ranges while yellow, orange, and red indicate 
progressively higher pressure levels 15• Although the amount of pressure and/or duration
of pressure causing skin damage·remain equivocal, evidence suggests that 30 mm Hg be 
considered the threshold for pressure measurement. Pressures U30 mmHg is believed to 
exceed capillary filling pressure, causing ischemia and skin damage 35•
6.2. Relevance/Significance: 
The war wounded are not immune to pressure ulcer development and unfortunately, as a 
result of the severity of their injuries and the process of medical evacuation, the risk for pressure 
ulcer development in wounded personnel returning from Iraq and Afghanistan has increased. 
Furthermore, the risk for pressure ulcers was identified, with one of the major military treatment 
centers noting an increase in the incidence of pressure ulcers among the returning wounded 7• 43• 
Pressure ulcers are characteristically more prevalent in adults V65 years of age due to changes 
associated with advanced age and failing health. They are also associated in individuals with 
limited or no mobility such as spinal cord injuries. The Global War on Terror has created a new 
population of young polytrauma patients with new challenges for the military health care system, 
one of which is preventing pressure ulcer development. Their injuries were most likely sustained 
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Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H w Amd5 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
in a hostile and austere environment where care was focused primarily on immediate life­
threatening interventions and medical evacuation to a higher level of care. Medical evacuation 
most likely occurred on a NA TO field litter, which can produce peak interface pressures greater 
than 30 mm Hg over bony prominences3 and limit tissue perfusion 35• The combination of poly­
trauma, traumatic brain injury, hypoperfusion, sedation, cervical collars, and medical evacuation 
places injured individuals at high risk for pressure ulcer development early in the care 
continuum. Finding ways to reduce or eliminate pressure ulcer development is a patient 
safety/quality of care issue. Interventions to help reduce/eliminate this problem as early in the 
continuum of care as possible would improve patient safety outcomes and raise quality of care. 
In the operational setting, that starts with the transport litter. 
Purpose: 
The purpose of this study is to measure peak skin interface pressures and the total area of the 
body exposed to skin interface pressures above 30 mm Hg while subjects are in the supine 
position. Two different support surfaces will be 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 System (FIS). These pressure measurements along with transcutaneous
oxygenation readings will allow us to determine differences between support surfaces.
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 aim.s: 
1. To determine the difference in the pressure redistribution qualities of the WELP when used as
the mattress on the NA TO 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 NA TO litter and Raven litter.
6.3. Hypotheses or Research Questions or Objectives:
Research Questions: 
1. Is there a significant difference in pressure redistribution qualities between the WELP and
Dolphin FIS mattresses on the NA TO Litter?
2. Is there a significant difference in the pressure redistribution qualities between the WELP and
Dolphin FIS mattresses on the Raven Litter?
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Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
3. Is there a significant difference in the pressure redistribution qualities of the WELP between
the NA TO and Raven 90C litters?
4. Is there a significant difference in the pressure redistribution qualities of the Dolphin FIS
mattress between the NATO and Raven litters?
Hypotheses: 
1. Pressure redistribution qualities will be greater for subjects on the Dolphin FIS than the WELP
in the supine position.
2. There is a difference in pressure distribution between men and women, given BMI level (high,
ideal) for subjects on the WELP padded NA TO with Raven litters.
3. There is a difference in pressure distribution between men and women, given BMI level (high,
ideal) for subjects on the Dolphin FIS padded NA TO with Raven litters.
4. There is a difference in pressure redistribution qualities of the WELP for subjects on the
NA TO and Raven litters.
5. There is a difference in pressure redistribution qualities of the Dolphin FIS for subjects on the
NA TO and Raven litters.
Outcome measures: 
Pressure Redistribution: Peak Pressure Index & Total Surface Area (TSA) 
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 (l>PI). 
Peak interface pressure is the highest average pressure (mm Hg) measured over vulnerable bony 
prominences ( occiput, sacrum, and bilateral scapula, buttocks, and heels). 
TSA will be measured in centimeters squared (cm2). Vulnerable bony prominences with skin 
interface pressures exceeding 30 mm Hg will be documented. 
Tissue Perfusion: Transcutaneous Oxygenation: 
Transcutaneous partial pressures of oxygen (tcp02) in millimeters of mercury (mmHg) is non­
invasive measurement/monitoring of the skin's surface partial pressure of oxygen. For purposes 
of this study, tcp02 measurements will be captured in the scapula region and expressed in mm 
Hg. Transcutaneous tissue perfusion has been used as the index of tissue viability by several 
groups 44•
45•
49• From the early work of Seiler et al. (19u7, 1983) 
47•
48, a baseline tcp02 value for 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
uncompressed soft tissue was established as 80 mmHg (10.7kPa). When tissue is subjected to 
pressure load, the tcp02 decreases dramatically due to occlusion of the blood flow underneath the 
pressure point. Bogie et al. ( 1992) 46 suggested a threshold value of tcp02 as 30 mmHg to 
indicate a significantly higher risk to tissue viability below this value. Bogie et al. ( 1995) so later 
suggested the threshold value for tcp02 as 44 mmHg. 
Body Mass Index (BMI) will be obtained for men and women obtained using tools (BMI 
calculator and/or tables) from the U.S. Department of Health and Human Services, National 
Institutes of Health, Heart, Lung and Blood Institute. For the purposes of this study, BMis will 
be categorized as high or ideal. 
Ideal = Normal BMI of 18.5-24.9 
High= Overweight BMI of25 -29.9 and Obese BMI of30 and above 
BMI Calculator can be found at 
http://www.nhlbi.nih.gov/health/educational/lose wt/BMl/bmicalc.htm 
BMI tables can be found at 
http://www.nhlbi.nih.gov/health/educational/lose wt/BMl/bmi tbl.htm 
Demographic characteristics will be obtained to describe the study sample. 
6.4. Research Design and Methods: 
Research Design 
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. Interface pressure will be measured using the XSensor X3 Pressure 
Mapping System 32x 80 medical mattress, W' resolution, 10,240 sensing points, 5-50 
& 10-200mmHg pressure range. The XSensor system uses force transducer arrays, which 
consist of a grid of transducers with half inch square resolution aligned in a matrix which 
is embedded in a 32 x 80 thin mat which is placed under the subject to map the entire 
body. Calibration of the pressure mapping system will be performed before and after each 
participant and the amount of drift evaluated. Mattress will be sanitized with disinfectant 
wipes between each participant. The sequence of the four surface combinations will be 
randomly assigned using Research Randomizer at https://www.randomizer.org for each 
participant. A stratified sampling scheme will be used to ensure adequate representation 
of the following attributes: gender, normal weight and overweight or obese as determined 
by BMI. 
Healthy adults with authorized access to Travis AFB will be offered the opportunity to 
participate in this study. After the consenting process is completed, subjects will be 
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DGMC Human Research Protocol 
scheduled for study participation. If time allows, the subject may be able to participate 
directly after completing the consent process. The subject will be assigned an 
identification (ID) number which will be annotated on the consent form and all of the 
data collection documents. The subject's name will only appear on the study consent 
form. All other study documents and data collection forms will only have the subject's ID 
number and no other personally identifiable information (PII). Subjects will be asked to 
wear a nonrestrictive single layer of garments for the study. They will be given a hospital 
gown to wear over the upper body. This will allow the study staff easy access to the 
subject's back for application of the transcutaneous oxygenation transducers. Females 
will not be required to remove their bra. Subjects will be asked their age and have their 
height and weight measured by a study team member. They will also be asked their litter 
and mattress preferences at the end of the study. The study portion should take 
approximately two hours to complete and can be broken into segments for multiple visits 
if necessary to accommodate a subjects schedule. 
Prior to skin oximetry readings, subjects will be asked to refrain from exercising, 
smoking and drinking caffeinated beverages for at least two hours before data collection. 
These readings will be performed using specialized equipment from the DGMC 
hyperbaric clinic. Bilateral transcuta.neous oxygenation will be obtained using a 
radiometer or Perimed™ instrument and by placing electrochemical transducers 
bilaterally in the region of the subject's scapula. The transducers and probes will be 
affixed to the skin after the site has been cleaned. To increase permeability of the skin to 
oxygen at the measuring sites, transducers will be heated to 44° C (11 l.2°F). After a 
calibration period of approximately 10-15 minutes, a constant transcutaneous partial 
pressure of oxygen will be obtained and recorded onto the patient data sheet. Baseline 
measurements will then be obtained ( about five additional minutes) with the subject 
sitting upright and no pressure applied to the back. 
Next, the subject will be asked to lay supine on the first of four randomly assigned litter 
mattress combinations. Because the litters will be resting on top of stands, special care 
will be taken by study team members to enSure subjects safely mount and dismount litters 
without injury. Subjects will be secured to the litters in accordance with Aeromedical 
Evacuation Equipment Standards (AFil0-2909, 23 July 2013 pages 73-74). 
"5.4.4.1. The patient is placed on the litter, covered with the sheet and blanket as 
necessary, and secured to the litter with 2 litter straps. The straps are placed mid-thigh 
and on the upper chest of the patient. Secure the litter straps so the buckles are on the 
aisle side of the litter, and lay the excess strap flat over the patient. DO NOT tie the 
excess strap in a knot. Litter straps will be visible for inspection. 
5.4.4.2. A mattress pad is recommended to prevent skin breakdown. " 
After the subject is positioned comfortably on the litter, the pressure mapping will begin. 
The peak interface pressure (the highest average pressure (mm Hg) measured over each 
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(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
body region) will be measured for the occiput, sacrum, bilateral scapula, buttocks and 
heel areas. The total body surface area exposed to skin interface pressure greater than 
30mm Hg will also be measured in centimeters squared ( cm2) for each body region. 
Measures of tissue perfusion using the tcp02 in mmHg will be measured for comparison 
to baseline data. This process will take approximately twenty minutes for each of the four 
iterations. An additional 30 minutes is required to change the ·litter and mattress 
configurations. After baseline data are captured and tcp02 measurements are taken with 
the subject supine on all four litter/mattress combinations, the session is complete. 
Data from subjects who do not complete all four litter/mattress combinations will be 
excluded from the analysis. An estimated 25% attrition rate is factored into this study to 
ensure that 43 completed data sets are obtained. 
6.S. Risks/Benefits:
•
There is a potential risk of injury from falling off the litter while attempting to mount or
dismount. This risk will be minimized by having a member of the research staff present
whenever a subject is on the litter. Staff will be available to assist participants on and off
the litter. A step stool will also be available to assist participants in safely mounting and
dismounting the litter.
•
There is also a potential risk of skin reaction to the adhesive which will hold the
transcutaneous oxygenation transducers in place. If a participant shows signs and/or
symptoms of skin irritation from the adhesive (redness, itching, rash or hives), the
adhesive will be removed and the participant will be encouraged to see their primary care
provider if the signs and/or symptoms do not quickly resolve or becomes worse after the
adhesive is removed. If the participant's initial reaction to the adhesive pads is severe
( difficulty breathing, face/lips, throat swelling, loss of consciousness) the subject will be
taken to the DGM C Emergency Department for treatment.
•
There is a potential risk of superficial bum from the tcp02 transducers. They are heated to
44 degrees Celsius which is 111.2 degrees Fahrenheit. If a participant shows signs and/or
symptoms of skin irritation (redness) or complains of burning, stinging or discomfort in
the area of the transducers, the transducers will be removed and the participant will be
encouraged to see their primary care provider if the signs and or symptoms do not
quickly resolve or become worse. If the participant needs immediate medical assistance,
they will be taken to the DGM C emergency department for treatment.
•
There is no anticipated individual benefit to subjects attributed to participation in
this study. Given the economic and overall health impact of pressure ulcer development,
a litter mattress system that can help reduce and/or eliminate pressure sore development
will be beneficial to military patients in theater and during transport.
6.6. Subject Population 
Form Revised as of 14 Apr 14 
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Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
Age Range: 
Sex: 
n o 18 y/o 
nMale 
D Children (S 18) 
n Female 
Vulnerable Population: p No 
D Yes (explain) 
Number of Subjects: 
•
Total Number of Subjects (nation-wide/study-wide): 43
•
Number of Subjects Planned for DGMC: 43
•
Number of Subjects Planned for (Specify Institution): NI A
Statistical tests will be 2-tailed with a significance level of 0.05. A 25% attrition rate is expected. 
A total of 53 subjects will be recruited in order to obtain 43 evaluable subjects with complete 
data sets. 
Inclusion/Exclusion Criteria: 
Inclusion: 
•
Adults over the age of 18 years with lawful access to Travis AFB.
Exclusion: 
•
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 72inches ( 6 feet ) - exceeds length of the litter & mattress surfaces
•
Body weight greater than 300 lbs
Form Revised as of 14 Apr 14 
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(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
•
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
Recruitment: 
1. Fliers - Will be posted throughout DGMC in approved/authorized locations such as
Heart, Lung & Vascular, Family Medicine, Family Health, Internal Medicine and Flight
Medicine clinics, cafeteria, elevators and other public areas. Advertisement posters/fliers
will also be posted and briefed in other public buildings on Travis AFB in order to ensure
recruitment of a sample representative of the active duty population. Research
coordinators may also sit near advertisement posters in the clinic waiting room, common
areas and cafeteria to answer any potential participant's questions.
2. Pamphlets - Will be placed in the waiting rooms of primary care clinics, base gym, Base
Exchange (BX}, hospital cafeteria and Grant Central Station.
3. E-mail/Newspaper- The research team may elect to advertise the study via e-mail sent
out by Wing public affairs office. The research team may also elect to advertise via Air
Force newspaper publications or other military newspapers at surrounding bases.
4. Marquee - Base and MDG
Consent: 
Subjects that have expressed interest in the study will be scheduled for an informed consent 
review/initial visit at the Clinical Investigation Facility (CIF). The subject will be brought to a 
private exam room or office where they will be individually consented by the research 
coordinator, PI or other qualified research team member. The study team member will explain 
the nature and scope of this study, discuss potential risks and benefits of participation, answer 
questions and ensure the subject fully understands the informed consent document. The study 
will be explained to the subject in lay terms. At least one hour of study staff time will be set 
aside for each participant to receive information, ask questions and consider participation in the 
study. The subject may elect to discuss the study with others if they so choose, prior to agreeing 
to participate. If the subject agrees to participate, the IRB approved informed consent document 
will be signed and dated by the subject and primary investigator or another delegated research 
team member. A copy of the signed consent form will be made and provided to the subject. The 
original signed consent form will be turned into the protocol office and a copy will be placed in 
the subject's study folder. The study folder will be stored in a locked filing cabinet in an office 
that is locked when the office owner is not in the room. Subjects will be assured that they may 
withdraw from_ the study at any time for any reason and their medical treatment will not be 
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FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
compromised. Research procedures will not start until the IRB approved informed consent 
document has been signed and dated by the subject and research team member. 
6.7. Safeguards for Protecting Subjects: 
•
All subjects will be treated in compliance with AFI 40-402 and applicable FDA and
DHHS guidelines.
•
Subjects will be monitored by study staff members at all times while on a litter to reduce
the risk of falling off the litter.
•
Study staff members will observe and assist subjects as needed when getting on and off
of the litter to reduce the subject's fall risk.
•
A step stool will be available to assist subjects in safely getting onto and off of the litter.
•
Subjects will be assigned an ID number after they are consented. This ID number will be
used to protect subject privacy and ensure confidentiality of recorded data. Subject's
protected health information will not be accessed or recorded during this research
protocol.
•
Data Entry: Data will be entered by authorized study personnel only. Upon completion
of data entry all hard copy documents will be stored as per the hard copy records policy
outlined below. All electronic data will be housed on the DGMC computer drive and will
only be accessible via a Common Access Card enabled computer accessible only to study
personnel within a secured office. All electronic transmissions of data will be encrypted
over a secured network.
•
Data security and transfer: Study documents will reside in the Clinical Investigation
Facility within the 60MDG SGSE Directory in a limited access password protected
directory designated exclusively to the study. Access will be granted only to study
personnel.
•
AES Encryption: To be in compliance with Government regulations study personnel
will utilize 128 bit AES encryption. AES is widely used across the government healthcare
sector to secure data-at-rest, data-in-motion and data-in-transit. All data transfers will be
made via (password protected CD, encrypted Electronic Mail, Secured FTP server, etc.).
All data files will utilize· the Advanced Encryption Standard approved cryptographic
algorithm used to protect electronic data.
•
Hard Copy Records: A copy of the IRB approved informed consent signed and dated by
the study subject and designee will be provided to the subject. The original signed and
dated IRB approved informed consent form will be placed with other study records, in a
locked cabinet and secured area within the IRB Protocol Office at the Clinical
Investigation Facility. A copy of the records will be in the coordinators offices located in
the Internal Medicine Clinic. These records will be accessible only to study personnel,
the IRB, and employees of authorized Federal departments and regulatory agencies.
Duplicates will be provided to the volunteer upon written request.
Form Revised as of 14 Apr 14 
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For Protocol Office use only: 
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Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
DGMC Human Research Protocol 
6.8. Data Collection/ Analysis: 
A sarriple size of 43 subjects is required for this study. This is similar to the sample size used by 
Col Elizabeth Bridges and colleagues in a study of skin interface pressure on a NATO litter3. In 
their study, a stratified sample (n= 32) with four support surfaces using a single canvas style 
NA TO litter was used. The surface effect was statistically significant for all peak pressure and 
surface area analyses (repeated-measures analysis of variance, p < 0.01, a 0.05, p 0.20). 
Interface pressure will be measured using XSensor X3 Pressure Mapping 32x 80 medical 
mattress, 5-50 & 10-200mmHg pressure range. The XSensor system uses force transducer arrays, 
which consist of a grid of transducers with half inch square resolution aligned in a matrix which 
is embedded in a 32 x 80 inch thin mat. This mat is placed under the subject to map their entire 
body. Calibration will be performed before and after each participant and the amount of drift 
evaluated. Mattress will be sanitized with disinfectant wipes between each participant. 
A stratified sampling scheme will be used to ensure adequate representation of the following 
attributes: gender, normal weight and overweight or obese as determined by BMI. 
The dependent variables (pressure mapping index = mmHg, Total body surface area {TSA) 
greater than 30 mmHg = cm2 ; transcutaneous oxygenation (tcp02) = mm Hg) will be measured 
on four different support surface combinations using the independent variables -
litters/mattresses: (l) NATO litter with the WELP; (2) NATO litter with the Dolphin FIS; (3) 
Raven litter with the WELP and (4) Raven litter with the Dolphin FIS. 
The subjects will service as their own controls. Baseline measures of tcp02 over bilateral 
scapular regions will be taken with the subjects sitting upright prior to having them lay supine on 
the support surfaces for pressure mapping with repeated tcp02 measurements. 
Data collected will include the subject's age, race, gender, height and weight the weight will be 
measured on a calibrated scale. 
Subject height arid weight will used to determine their BMI. 
BMI is an individual's weight (in kilograms) divided by their height squared (in centimeters). 
The BMI calculator or tables from the U.S. Department of Health and Human Services National 
Institutes of Health (NIH) web will be used to calculate BMI for this study. 
http://www.nhlbi.nih.gov/health/educational/lose wt/BMI/bmi tbl.htm 
NIH BMI Categories: 
For the Purposes of this study: BMI 
Underweight = <18.5 
Normal weight = 18.5-24.9 
Ideal = 18.5-24.9 
Overweight = 25-29.9 
High= 25 or greater 
Obesity = BMI of 30 or greater 
Form Revised as of 14 Apr 14 
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For Protocol Office use only: 
Protocol title: NATO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
This is a cross-factor design that will use a Repeated Measures Analysis of Variance (ANOVA) 
model to examine the effects ofwithin·and between factors. Mean change in tcp02 (mmHg), 
LOP pressure units, surface area (cm2> will be computed. All'analyses will be done using 
ST AT A v 13.0 (College Station, TX). 
Source of Research Material per Participant: 
Source of Research Material per Participant 
Standard Care 
Research Driven 
Demographic Data 
0 
1 
Age in years (89+ for anyone over 89 years of age) 
0 
1 
Gender - Male or Female 
0 
1 
Body Mass Index <BMI) 
0 
1 
Height (centimeters/inches) 
0 
1 
Weight (pounds/ldlograms) 
0 
1 
Pressure Maooing (mmHg) - NATO Litter (WELP) 
0 
1 
Transcutaneous Oxygenation (Tcp02) mmHg 
0 
4 
Pressure Mapping (mmHsi) - NATO Litter (FIS) 
0 
1 
Transcutaneous Oxygenation (Tcp02) mmHg 0 
4 
Pressure Mapping (mmHg) - Raven Litter (WELP) 
0 
1 
Transcutaneous Oxygenation (Tcp02) mmHg 0 
4 
Pressure Maooing (mmHg) - Raven Litter (FIS) 
0 
1 
Transcutaneous Oxygenation (Tcp02) mmHg 0 
4 
7. Conflict of Interest
None 
8. Investigation Schedule
Estimated Timeline: IRB approval estimated for May 2016. PI PCS'd and alternate deployed, 
therefore, anticipated protocol start date Jan 2018 protocol start (need additional equipment, 
supplies, also requesting additional funding). 
Recruitment 
Enrollment 
Form Revised as of 14 Apr 14 
Jan 
Y2Q3 Y2Q3 Y2Q4 Y3Ql 
Y3Q2 Y3Q3 Y3 
2018 
Q4 
Y2Q2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
Data Collection 
X 
Statistical Analysis 
Publications/Reports 
9. Use oflnvestigational Drug(s)
10. Use of Investigational Device(s)
11. Support Required
CIF Support: 
X 
No 
No 
X 
X 
0Yes 
0Yes 
X 
X 
X 
X 
X 
X 
Administrative, bio-statistician consultation and Clinical Research Coordinator to help with 
subject recruitment, informed consent process and data collection support is required. (See 
attachments for Letter of Support). 
Other Support: 
DGMC Hyperbaric Clinic: Staff and equipment for Transcutaneous Oximetry (tcp02) 
(see attachments for Letter of Support). 
See attached Letters of Support 
12. Budget, Equipment, and Supplies:
Requesting Funds:  Yes 
DNo 
R&D 
DO&M 
DHMJ
DOTHER (explain source): 
X 
Study Year 
Item Description 
Unit of Issue 
Cost/UOI 
Quantity 
Total Cost 
2015 
Dolphin FIS 
2015 
X3 Sensor 
Sleeves 
2015 
NATO Litter 
NSN: 6530-
01-380-7309
2015 
Litter Raven 
90C NSN: 
6530-01-
432-5114
2015 
Litter Stands 
NSN: 6530-
01-618-7 419
2015 
Mattress 
Litter 
Form Revised as of 14 Apr 14 
(UOI) 
1 
19,470.00 
1 
19,470.00 
100 
150.00 
1 
150.00 
1 
397.78 
1 
397.78 
1 
391.25 
1 
391.25 
1 pair 
778.00 
2 
1556.00 
1 
320.00 
1 
320.00 
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Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
2016 
Dell Laptop 
1 
3,368.39 
1 
3,368.39 
Computer 
2016 
XSENSOR 
1 
12,650.75 
1 
12,650.75 
X3 Pressure 
Mapping 
System 
2016 
Biopac® 
1 - MP-160 
31,000 
1 
31,000 
Laser 
Doppler 
2 -LDF 
package 
100c 
(includes: 
MP-160, 
2-LDF
LDF 100c, 
Probe TSO 
LDF Probe 
TSD 140) 
2016 
TCOM 
1 
1,500 
2 
3,000 
probes 
TCOM 
2016 
Fixation 
1 Box of 100 
150.00 
2 
300.00 
rings 
TCOM 
2016 
membrane 
1 Box of 12 
132.31 
10 
1,323.10 
181 I understand that the funding is the responsibility of the Pl, which includes; management, 
tracking, recording and must be reported to the IRB annually with your continuation report. 
13. Manpower
Rank 
AFSC 
Col 
46N3 
Lt Col 
46N3 
CRC 
Civ/CTR 
CRC 
Civ/CTR 
CRN 
CTR 
CRN 
CTR 
RA 
CTR 
RA 
CTR 
14. Institutional Official (IO)
(name redacted 23 Jan 20), Col, USAF, MC 
Commander, 60th Medical Group 
# hours duty time 
# hours off-duty 
time 
80 
40 
240 
40 
80 
0 
0 
40 
0 
40 
0 
80 
0 
80 
0 
Form Revised as of 14 Apr 14 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
David Grant USAF Medical Center, Travis AFB, CA 
(contact information redacted 23 Jan 20)
15. Bibliography
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
1. Chou R, Dana T, Bougatsos C, Blazina I, Starmer A, Reitel K, Buckley D.
Pressure Ulcer Risk Assessment and Prevention: Comparative Effectiveness. Comparative
Effectiveness Review No. 87. (Prepared by Oregon Evidence-based Practice Center under
Contract No. 290-2007-10057-I.) AHRQ Publication No. 12(13)-EHC148-EF. Rockville, MD:
Agency for Healthcare Research and Quality. May 2013.
www.effectivehealthcare.ahrg.gov/reports/final.cfm.
2. Bale S, Finlay I, Harding KG. Pressure sore prevention in a hospice. J Wound Care.
1995;4(10):465-8. PMID: 8548573.
3. Bridges EJ, Schmelz JO, Mazer S: Skin interface pressure on the NATO litter. Military
Medicine, 2003;168(4): 280-286.
4. Hanson DS, Langemo D, Anderson J, Thompson P, Hunter S. Wound & skin care: Can
pressure mapping prevent ulcers? Nursing. 2009; 6: 50-51.
5. International review. Pressure ulcer prevention: pressure, shear, friction and microclimate in
context. A consensus document. London: Wounds International, 2010
6. Hatzfeld, J., Dukes, S., & Bridges, E. Innovations in the enroute care of
combat casualties. Annual Review of Nursing Research (Annu Rev Nurs Res)
2014; 32(1):41-62.
7. Crumbley, D. R., & Kane, M. A .. Development of an Evidence-Based Pressure Ulcer
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Prevention, and Intervention Among Young Service Members Returning from OIF/OEF.
Nursing Clinics of North America (Nurs Clin N Am) 2010; 45(2):153-168.
doi: 10.1016/j.cnur.2010.02.009
8. European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel.
Prevention and treatment of pressure ulcers: quick reference guide. Washington, DC: National
Pressure Ulcer Advisory Panel; 2009.
9. National PU Advisory Panel (NPUAP) and European Pressure Ulcer Advisory Panel
(EPUAP): Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline.
Washington, DC: NPUAP, 2009.
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H w Amd5 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
10. Performance Improvement: Use of refined protocols reduces pressure ulcer rates. OR
Manager. 2013; 29(12):1-4.
11. US Department of Health & Human Services, Agency for Healthcare Research and Quality
Are we ready for this change: Preventing pressure ulcers in hospitals a toolkit for improving
quality of care. http://www.ahrg.gov/professionals/systems/long-term-care/resources/pressure­
ulcers/pressureulcertoolkit/putool l .html
12. Reddy M, Gill S, Rochon P., et al. Preventing pressure ulcers: a systematic review. JAMA.
2006; 296(8):974-984.
13. Hyun, S., Vermillion, B.,RN, Newton, C., Fall, M., Li, X., Kaewprag, P., Susan Moffatt­
Bruce, S., & Lenz, E. R. Predictive validity of the braden scale for patients in intensive care
units. American Journal of Critical Care (AJCC) 2013; 22(6): 514-520.
14. Edlich, R. F., Mason, S. S., Vissers, R. J., Gubler, K. D., Thacker, J. G., Pharr, P . ... , & Long,
W. B., II. Revolutionary advances in enhancing patient comfort on patients transported on a
backboard. American Journal of Emergency Medicine. 201 O; 29(2): 181-186.
15. 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.
Journal of Wound, Ostomy and Continence in Nursing. 2002; 29, 143-148.
16. Hill-Rom. (2007). Advanced surface technology for positive patient outcomes. Retrieved
from http://www.hill-rom.com/usa/Products/Browse-by-Need/Pressure-Ulcer-Management/
17. Junkin, J., & Gray, M. Are pressure redistribution surfaces or heel protection devices effec­
tive for preventing heel pressure ulcers? Journal of Wound, Ostomy and Continence in Nursing.
2009; 36(6):602-608.
18. Kaitani, T., Tokunaga, K., Matsui, N., & Sanada, H. Risk factors related to the development
of pressure ulcers in the critical care setting. Journal of Clinical Nursing.201 O; 19(3/4):414-421.
19. Legood, R., & Cullum, N. A. (2008). Support surfaces for pressure ulcer prevention
(Review). [ evidence-based practice]. Cochrane Database of Systematic Reviews. 2008; 97.
20. Mimura, M., Ohura, T., Takahashi, M., Kajiwara, R., & Ohura, T. J. Mechanism leading to
the development of pressure ulcers based on shear force and pressures during a bed operation:
Influence of body types, body positions and knee positions. Wound Repair and Regeneration.
2009; 17(6):789-796.
21. Mcinnes E, Jammali-Blasi A, Bell-Syer SEM, Dumville JC, Cullum N. Support surfaces for
pressure ulcer prevention. Cochrane Database of Systematic Reviews 2011, Issue 4. Art. No.:
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmd5 
CD001735. DOI: 10.1002/14651858.CD001735.pub4. 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
22. Stryker. Strykers' Pioneer (TM) pressure redistributing stretcher surface is the first of its kind
for emergency departments. 2006; Retrieved from
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23. Naccarato, M. K., & Kelechi, T. Pressure ulcer prevention in the emergency department.
Advanced Emergency Nursing Journal. 2011; 33(2):155-162.
24. Soban, L., Hempel, S., Munjas, B.A.: Miles, J., Rubenstein, L.V. Preventing pressure ulcers
in hospitals: A systematic review of nurse focused quality improvement interventions. The Joint
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pressure ulcer prevalence in a surgical intensive care unit. J Wound Ostomy Continence Nurs.
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
33. Kohanzadeh, S., Breithaupt, A., Bondarchuk, A., Bhavsar, D., Evers, L., Broder, K., Dobke,
M., Bodor, R. Poster "Effectiveness of the Dolphin bed as a tool to improve tissue perfusion in
point of compression". Division of Plastic Surgery, University of California, San Diego, CA.
2009.
34. PERIMED. PeriFlux System 5000 (instrument version 1.70-1.79) Extended User Manual.
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35. Gefen, A. How much time does it take to get a pressure ulcer? Integrated evidence from
human, animal, and in vitro studies. Ostomy Wound Manage. 2008;54(10): 26-28, 30 -35.
36. The Military Health Systems's Partnership for Patients Campaign. Implementation guide for
pressure ulcers. February, 2013.
37. Reams, W. H., & Danley, D.L. Performance of selected fabrics on the decontaminable litter
and litter mattress to correct a problem of unexpected sliding during patient loading on a C-9
(Nightingale) aircraft. Technical Report 9202. U.S. Army Biomedical Research and
Development Laboratory, Fort Detrick, MD .1992
38. Lovell, M.E., & Bradshaw, P. Pressure effects from a military stretcher.J R  Army Med
Corps. 1993; 139: 98-99. Downloaded from www. jramc.bmj.com on August 8, 2014 - Published
by group.bmj.com.
39. Reuler J. B., Cooney, T.G. The pressure sore: pathophysiology and principles of
management.Ann Intern Med.1981 ;94:661-666.
40. Kosiak, M. Etiology of decubitus ulcers. Arch Phys Med Rehabil. 1961; 41: 19-28.
41. Joerns Healthcare. Dolphin Fluid Immersion Simulation®. 2013. www.dolphinfis.com
Last accessed 8 March 2014.
42. Joerns Healthcare Inc. Auto Vector® Bed Systems with Fluid Immersion Simulation®
transforming wound management. (Dolphin Brochure 6220219 Rev A. pdt). 2010.
www .joerns.com Last accessed 8 March 2014.
43. Mortimer, D.L., Dukes, S., Thomas, M., Maupin, G., & Bridges, E. "Risk Factors for
Pressure Ulcer Development in CCA TT Patients" (Power point presentation and poster)
Presented at the TriService Nursing Research Program (TSNRP) Dissemination Course, 14-18
Sep 2014.
Form Revised as of 14 Apr 14 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
44. Dowd, G.S.E., Linge, K. & Bentley, G. 1983. "Measurement oftranscutaneous oxygen
pressure in normal and ischaemic skin. The Journal of Bone and Joint Surgery.1983;65(1): 79-
83.
45. Makhous, M., et al. Measuring tissue perfusion during pressure relief maneuvers: Insights
into preventing pressure ulcers. The Journal of Spinal Cord Medicine. 2007;30(5): 497-507.
46. Bogie KM, Nuseibeh I & Bader DL. Transcutaneous gas tensions in the sacrum during the
acute phase of spinal cord injury. Proc Inst Mech Eng [H]. 1992;206:1-6.
47. Seiler, WO & Stahelin HB. Skin oxygen tension as a function of imposed skin pressure:
implication for decubitus ulcer formation. J Am Geriatr Soc. 1979;27:298-301.
48. Seiler WO, Allen S & Stahelin HB. Decubitus ulcer prevention:a new investigative method
using transcutaneous oxygen tension measurement. Am Geriatr Soc. 1983;31 :786-789.
49. Sheffield, PJ. Dietz, D., Posey, Kl., & Ziemba, A. Use oftranscutaneous oximetry and laser
doppler with local heat provocation to assess patients with problem wounds. Wound Care
Practice. Best Publishing Company. 2004. 117-156.
50. Bogie KM, Nuseibeh I. & Bader DL. Early progressive changesin tissue viability in
theseated spinal cord injured subject. Paraplegia. 1995;33:141-147.
51. Kirkland-Walsh, H., Teleten 0., Wilson, M. & Raingruber, B. Pressure mapping comparision
of four OR surfaces. AORN. 2015; 102(1): 61el-61e9.
16. Attachments:
1. CIF Letter of Support
2. DGMC Hyperbarics Clinic Letter of Support
Form Revised as of 14 Apr 14 
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For Protocol Office use only: 
Protocol title: NA TO Litter: Fluid Immersion System 
(FIS) versus Traditional Mattress for Pressure Dispersion 
FDG20160005H wAmdS 
(investigator names redacted 23 Jan 20) 
DGMC Human Research Protocol 
17. Commander's Acknowledgment of Review and Approval
Principal Investigator: I am aware that I am not authorized to accept any funds or other form 
of compensation for conducting research. All subjects will be treated in compliance with 
applicable Air Force, DOD and federal regulations, as well as applicable FDA and DHHS 
guidelines. I have read, understand, and signed the attached Certificate of Compliance. I 
understand I must complete a review of this protocol at least every 12 months to prevent 
expiration of the study's approval. I will notify the protocol office prior to relocations, 
separation actions, or closure. 
D Initial Submission 
(ALL signatures required) 
information redacted 23 Jan 20
!ZI Amendment Submission 
(PI signature ONLY) 
23 Oct 2019 -----
Date 
Form Revised as of 14 Apr 14 
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