Evaluation of a Prototype System for Generating Conditions of Orthostatic Hypotension and Blood Pooling in the Lower Body
Phase: NA
Conditions: Orthostatic Hypotension, Ischemia, Hypoxia
Sponsor: Military Institute of Aviation Medicine

 
Military Institute of Aviation Medicine 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research Protocol 
 
 
 
 
 
Evaluation of a prototype system for generating conditions of 
orthostatic hypotension and blood pooling in the lower body 
 
 
 
 
Project DOBR/0052/R/ID1/2012/03 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
November 10, 2017 

Dziuda et al. 
Research Protocol:  Table of Contents 
ORTHO-LBNP 
2 
Table of Contents 
Project summary ........................................................................................................................ 3 
General information ................................................................................................................... 4 
Protocol Title ......................................................................................................................... 4 
Short title ................................................................................................................................ 4 
Acronym ................................................................................................................................. 4 
Sponsor .................................................................................................................................. 4 
Primary Investigator .............................................................................................................. 4 
Other medical and/or technical institutions involved in the research ................................... 4 
Rationale & background information ........................................................................................ 5 
Study goals and objectives ......................................................................................................... 6 
Study Design .............................................................................................................................. 6 
Methodology .............................................................................................................................. 7 
Prototype system .................................................................................................................... 7 
Research scenarios .............................................................................................................. 11 
Safety Considerations .............................................................................................................. 12 
Follow-Up ................................................................................................................................ 13 
Data Management .................................................................................................................... 13 
Statistical Analysis Plan ........................................................................................................... 13 
Quality Assurance .................................................................................................................... 14 
Expected Outcomes of the Study ............................................................................................. 14 
Dissemination of Results and Publication Policy .................................................................... 15 
Duration of the Project ............................................................................................................. 15 
Problems Anticipated ............................................................................................................... 15 
Project Management ................................................................................................................ 16 
Ethics........................................................................................................................................ 16 
Informed Consent Forms ......................................................................................................... 16 
Literature .................................................................................................................................. 16 
Budget ...................................................................................................................................... 18 
Other support for the Project .................................................................................................... 18 
Collaboration with other scientists or research institutions ..................................................... 18 
Links to other projects ............................................................................................................. 18 
Curriculum Vitae of investigators ............................................................................................ 18 
PI's Curriculum Vitae .......................................................................................................... 18 
Other investigators ............................................................................................................... 19 
Research activities of the PI ..................................................................................................... 20 
Financing and Insurance .......................................................................................................... 20 
Appendix A .............................................................................................................................. 21 
Appendix B .............................................................................................................................. 23 
Appendix C .............................................................................................................................. 25 
 

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Project summary 
The project aims to construct and evaluate a prototype system that enables military pilots to 
train under conditions of orthostatic hypotension and ischemic hypoxia. Both of these 
phenomena are experienced by aircraft crews of mainly highly manoeuvrable aircraft, and their 
syndromes include loss of colour vision, loss of peripheral vision, blackout and finally 
G-induced loss of consciousness (G-LOC). A motorised tilt table to generate orthostatic 
(ORTHO) stress combined with an automatically controlled lower body negative pressure 
(LBNP) chamber to extort pooling of blood in the lower extremities will be developed in order 
to obtain new knowledge on counteracting the above-mentioned effects and minimising the 
risk of their occurrence. This will help optimise the selection procedures of candidates with the 
best physiological predispositions to work as military pilots. The system will be equipped with 
modules for monitoring biomedical parameters of a subject, including cerebral oxygenation, 
which will ensure their safety and provide a source of data for performing advanced analyses. 
The ORTHO-LBNP system will be subjected to comprehensive laboratory tests. After 
a successful testing, a research protocol will be developed and a pilot study will be carried out 
involving pilots and/or cadets of the Polish Air Force Academy. It is anticipated that new 
indicators will be proposed as a result of the pilot study to enable an objective assessment of 
the predispositions to pursue a military pilot career. The prototype system developed within 
the project will also be easily adaptable to the needs of clinical and sports medicine as well as 
rehabilitation. As an output of the project realisation, the ORTO-LBNP system will be 
developed at technology readiness level 9 and presented to the scientific community in the 
form of a series of papers that will report on the results of the system designing phase and the 
pilot study. 
 
 

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Research Protocol:  Part I 
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General information 
Protocol Title 
Evaluation of a prototype system for generating conditions of orthostatic hypotension and 
blood pooling in the lower body 
 
Short title 
Evaluation of the ORTHO-LBNP system 
 
Acronym 
ORTHO-LBNP 
 
Sponsor 
Military Institute of Aviation Medicine 
ul. Krasińskiego 54/56 
01-755 Warszawa 
Poland 
 
Primary Investigator 
Łukasz Dziuda, D.Sc., Ph. D. 
ul. Krasińskiego 54/56 
01-755 Warszawa 
Poland 
tel.:  +48 261-852-621 
email:  ldziuda@wiml.waw.pl 
 
Other medical and/or technical institutions involved in the research 
Institute of Medical Technology and Equipment 
ul. Roosevelta 118 
41-800 Zabrze 
Poland 
 
Nałęcz Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of 
Sciences 
ul. Ks. Trojdena 4 
02-109 Warszawa 
Poland 
 
Polish Air Force Academy 
ul. Dywizjonu 303 no. 35  
08-521 Dęblin 
Poland 
 
ETC-PZL Aerospace Industries Sp. z o.o. 
Al. Krakowska 110/114 
02-256 Warszawa 
Poland 
 

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Rationale & background information 
A number of cardiovascular disorders are observed when human body is subjected to 
accelerations other than the gravity of Earth. Although the first consideration on the medical 
aspects of the influence of the variable gravitational field date back to 1818 [1], only the rapid 
development of human centrifuges, tilt tables and under- or overpressure chambers in the 1960s 
allowed for controlling the gravitational stimuli quantitatively [2]-[5]. Accelerations directed 
from head to feet (+Gz) and accelerations acting oppositely (-Gz) have been of particular 
interest to space and aviation medicine. In the first case, blood moves toward the lower 
extremities and its drain from the brain may cause oxygen deficiency leading in sequence to 
greyout, tunnel vision, blackout, and G-induced loss of consciousness (G-LOC) [6]. The 
adverse symptoms of +Gz acceleration are additionally intensified if the positive stimulus is 
preceded by -Gz acceleration, i.e., a push-pull effect occurs [7]. The literature explains this 
increased regulatory response through the significant contribution of sympathetic activity [8]. 
A list of states deviating from the Earthly gravity is complemented by weightlessness and 
microgravity, i.e., zero- and near zero-gravity states, respectively. These aspects are mainly 
researched in the context of space missions during which, promptly upon entering 
weightlessness, blood shifts toward the head [9]. The cardiovascular system adapts to the new 
conditions after a time [10], however blood content in the lower part of the body remains 
unnaturally low and long-term stay in space impairs vestibulo-cardiovascular reflex [11] and 
leads to, e.g., a change in heart shape and loss of heart muscle mass [12]. Returns from space 
missions are also aggressive for the body due to symptoms accompanying them, such as 
orthostatic intolerance, hypotension, dizziness, and syncope [13]. For the above-mentioned 
reasons, methods for increasing the body tolerance to +Gz and -Gz accelerations and for 
counteracting the disadvantageous effects of weightlessness are of fundamental meaning in 
space and aviation medicine. 
 
In general, three methods for real or simulated changing direction and value of the gravity field 
vector are used: 
­ centrifugation, 
­ head up tilt (HUT) and head down tilt (HDT) tests, 
­ lower body negative pressure (LBNP) and lower body positive pressure (LBPP) tests. 
 
Modern human centrifuges enable for mapping acceleration profiles that reflect flight 
conditions with great accuracy, and the pilot is subjected to real accelerations. Although the 
centrifuge is recognised as the best flight simulator, high costs of its construction, operation 
and maintenance have resulted in searching for alternatives. One of them is a tilt table. This 
device of modest complexity offers a generation of stimuli in the range of -1 g (tilt of -90°, 
HDT) to 1 g (tilt of +90°, HUT) in the Gz axis. Despite this limitation, even weak stimuli below 
1 g in the Gz axis (+1 Gz, in short) trigger a series of reflex reactions whose monitoring allows 
for assessing the efficiency of the cardiovascular regulatory mechanisms. On the other hand, 
placing the lower body of the pilot (usually from the waist area down) in an underpressure 
chamber simulates cardiovascular effects corresponding to stimuli greater than +1 Gz. Some 
authors report on supine LBNP at -50 mmHg (millimetre of mercury), which induced the 
hemodynamic response similar to that observed at an acceleration value of +2 Gz [14]. To 
simulate +2 Gz heart rate (HR) effects in weightlessness, an increase in LBNP to -90 mmHg is 
required [15]. Other authors attempt to prove that the LBNP test can be a more effective and 
practical stimulus than centrifugation [16]. 
 

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The underpressure chamber is often placed on the tilt table in order to strengthen the +Gz 
stimulus by using LBNP and moving the pilot from supine to vertical position simultaneously. 
Moreover, this configuration allows for achieving the push-pull effect when the LBNP and/or 
HUT exposures are preceded by a HDT try. Similarly to the HDT test, the LBPP technique 
aims to reverse or prevent the effects of orthostatic hypotension. It is however much less 
commonly used, mainly due to problems met when designing one device purposed for 
generating positive and negative pressures. 
 
The Military Institute of Aviation Medicine is the only institution in Poland, where candidates 
for military aviation are verified for their physiological predispositions. They have to meet two 
main criteria to get the highest health category that predisposes them for training on highly 
manoeuvrable aircraft. One of them is to obtain the right result of medical and psychological 
tests, whereas the other criterion is to withstand a linearly increasing acceleration (0.1 Gz/s) up 
to a value of +5.7 Gz, generated by the human centrifuge available at the institute. In order to 
verify the possibility of performing selection procedures with a limited outlay, we have 
developed the ORTHO-LBNP system, i.e., a prototype device consisting of the tilt table to 
generate orthostatic stress and the underpressure chamber to extort pooling of blood in the 
lower extremities, as during +Gz accelerations. Although typical values of LBNP do not 
descent below -100 mmHg, i.e., it would be difficult to achieve of effects corresponding to an 
acceleration greater than +4 Gz, a properly matched tilt and LBNP profiles can generate 
physiological disorders at a level sufficient to evaluate the subject’s resistance to accelerations 
or to develop the ability to adapt variable gravitational stimuli. 
 
 
Study goals and objectives 
The objectives of the pilot study can be summarised as follows: 
1. Testing the prototype device with participation of humans, where the result measures relate 
both to feasibility and health outcomes. 
2. Checking the system dynamics and verifying how faithfully the system maps the 
pre-programmed tilt and LBNP profiles. 
3. Verifying the signal quality and analysing changes in basic physiological parameters when 
applying a sequence of the pre-programmed tilt and LBNP profiles. 
4. Verifying if new indicators can be proposed for an objectivised assessment of the 
physiological predispositions of candidates for military aviation. 
 
 
Study Design 
The pilot study consists of two research scenarios, in which two different sequences of the 
interventions taking the form of the pre-programmed tilt and LBNP profiles are to be 
investigated. The two study scenarios are designed based on the knowledge and experience of 
the investigators in the fields of examinations of military pilots in real and simulated conditions 
[17],[18]. 
 
Scenario I is designed to initially verify the potential impact of the prototype system on the 
human body. For this purpose, only basic tilt and LBNP stimuli of relatively slowly increasing 
intensities will be used, and the group of subjects will include only subjects with flight 
experience. Up to 20 PAFA cadets shortly before graduation, including women and men, will 

Dziuda et al. 
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be involved in the pilot study (experimental arm 1). The subjects will be healthy, aged between 
20 and 30 years old. Scenario I will take almost 24 min. 
 
Scenario II is to compare subjects with and without flight experience using rapid tilt and LBNP 
stimuli as well as a push-pull stimulus. Up to 30 subjects including up to 15 pilots, i.e., flight 
school adepts shortly after graduation and/or PAFA cadets shortly before graduation, and up 
to 15 students of the Aviation High School in Dęblin, Poland, including women and men will 
be involved in the study (experimental arm 2). The subjects will be healthy, aged between 18 
and 30 years old. The students of the Aviation High School will participate in the study as 
a reference group, without flight experience. Scenario II will take 16 min. 
 
 
Methodology 
Prototype system 
The prototype of the ORTHO-LBNP system comprises a tilt table, LBNP chamber and medical 
monitoring subsystem. 
 
Tilt table 
The tilt table is placed on two axes terminated on both sides with guide blocks. One of the axes 
cooperates with a horizontal rail, whereas the other is associated with a vertical rail. The 
vertically moved guide blocks are driven by a rotary engine, and the horizontally moved guide 
blocks support the tilt table. The tilt table and thus the subject move around a variable axis of 
rotation. As shown in Fig. 1, the subject’s body slidingly moves in the head-to-feet axis while 
changing mainly the level of the upper part of the body, both in HUT and HDT tests. 
Trajectories of three human body characteristic points, i.e., head, waist and feet, during HUT 
and HDT tests are illustrated by the red and blue solid lines, respectively. Additionally, 
displacements of the guide blocks on the horizontal and vertical rails are marked with the white 
and black dotted lines, respectively. Such a movement of the subject lying on the tilt table can, 
to some extent, simulate flight conditions at a relatively low technical complexity and average 
costs. This drive subsystem has been registered in the Patent Office of the Republic of Poland 
[19]. The tilt table meets the following requirements: 
­ range of tilt angles:  -45° to +80°, 
­ rate of tilt changes:  up to 45°/s. 
 
 
Fig. 1.  Trajectories of the body on the tilt table during (a) HUT and (b) HDT tests. 
 
LBNP chamber 
Initially, we considered the use of a buffer tank between the underpressure chamber and 
a compressor or vacuum pump to generate negative pressure, as shown in Fig. 2 (dotted line). 
This required applying controllable valves between the buffer tank and the underpressure 
+80°
0°
0°
–45°
(a)
(b)

Dziuda et al. 
Research Protocol:  Part I 
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chamber, and a safety valve to reduce pressure in the tank. The compressor was to achieve 
a much greater negative pressure in the buffer tank than required in the underpressure chamber. 
In this way a low–flow compressor could be used to reduce pressure in the chamber at the 
required change rate. Nevertheless, the constructors decided to use only elements that meet the 
definition of low–pressure equipment according to Directive 2014/68/EU relating to the 
making available on the market of pressure equipment. Although this required the use of 
a high–flow compressor to achieve an appropriate pressure dynamics in the chamber, the 
subsystem for generating underpressure was simplified by eliminating the buffer tank (Fig. 2, 
solid line). Additionally, the maximum negative pressure achieved by the compressor can be 
lower than that in the case of a compressor operating in the configuration with the buffer tank. 
The LBNP chamber is based on an aluminium frame with thermoformed polycarbonate sheet. 
As a result of numerical simulations, the maps of equivalent stresses and total displacements 
for particular segments of the chamber, shown in Fig. 3, were obtained. The LBNP chamber 
meets the requirements as follows: 
­ range of generated underpressure:  0 to -100 mmHg, 
­ rate of underpressure changes:  up to 20 mmHg/s. 
 
 
Fig. 2.  Pneumatic subsystem for generating underpressure in the LBNP chamber. 
 
 
Fig. 3.  Strength analysis of the LBNP chamber. 
 
The tilt table and LBNP chamber underwent tests for compatibility with the harmonised 
standards in regards to machinery Directive 2006/42/EC, and hence these two mechanical 
subsystems have been CE marked. Moreover, the safety of the prototype system has been 
confirmed by the positive results of laboratory tests carried out with respect to Directive 
93/42/EEC concerning medical devices. 
 
Physiological monitoring 
A subsystem for monitoring physiological parameters in subjects undergoing tilt and 
underpressure tests is necessary to carry out examinations safely and to classify subjects 
Underpressure chamber
Safety valve
Valve block
Pressure 
measurement
Buffer tank
Valve block
Compressor/
vacuum pump
Pressure 
measurement
Safety valve
Control module
Pressure:  –0.013 MPa
Max. stress:  10.43 MPa
Max. displacement:  3.69 mm
Pressure:  –0.050 MPa
Max. stress:  40.12 MPa
Max. displacement:  14.18 mm

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Research Protocol:  Part I 
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reliably. The constructors decided to build their own measurement subsystem where all the 
medical recorders in the form of modules were integrated in electromagnetically (EM) shielded 
enclosures to which the wires from the electrodes and sensors located on the subject’s body 
were connected as in modern operating tables. Fig. 4 (a) shows the general configuration of the 
subsystem that consists of modules for the following types of diagnostics: ECG, pulse oximetry 
(POx), electromyography (EMG), skin conductance level (SCL), NIBP, body temperature 
(TEMP), impedance reography (REO), electroencefalography (EEG), capnography (CAPNO), 
near infrared spectroscopy (NIRS), and continuous non-invasive arterial pressure (CNAP). The 
modules for measuring ECG, EMG, SCL, TEMP, REO, and EEG were developed entirely by 
the engineering team, whereas the POx (WW3711 by Smith Medical), NIBP (Advantage Mini 
by SunTech Medical), CAPNO (miniMediCO2 by Oridion Medical), CNAP (CNAP by 
CNSystems Medizintechnik AG), and NIRS (7610 OEM by Nonin) modules were built on the 
basis of commercially available certified OEM solutions. In addition to the commercial off-
the-shelf 2-channel NIRS device, we used an in-house-designed 6-channel module to record 
oxygenation changes in the left and right frontal lobe, motor cortex, and visual cortex. All the 
modules were connected to the operator’s station and the control module via the data hub. The 
module set and data hub were closed in a propacPRO series EM shielded enclosure by Schroff 
(Fig. 4 (b)), but the in-house-designed NIRS module was enclosed separately in another 
propacPRO housing due to its size (Fig. 4 (c)). The medical monitoring subsystem has been 
certified with a CE marking indicating conformity with the standards harmonised with 
Directive 93/42/EEC. 
 
 
Fig. 4.  Medical monitoring subsystem: the (a) block diagram, (b) main module box by 
the Institute of Medical Technology and Equipment, Poland, (c) in-house-designed 
NIRS module box by the Nałęcz Institute of Biocybernetics and Biomedical Engineering 
of the Polish Academy of Sciences. 
 
 
Software 
A computer application for controlling the tilt table and LBNP chamber, as well as receiving, 
analysing and presenting data from the medical modules during examination was developed 
during construction of the prototype system. The software runs on the Microsoft .Net 
Framework 4.0 platform. It was prepared in the C # language using the Visual Studio 
environment. The source code was developed according to the applicable design principles and 
software engineering principles. A set of tests for the individual software units and integration 
tests were also prepared. Similar to the medical monitoring subsystem, the computer 
Medical power 
supply
Data hub
To 
operator s 
station
To control module
Main module box (EM shielded enclosure)
 NIRS module box (EM shielded enclosure 2)
N
L
ECG: standard limb leads,
6 channels, band–pass filtering
POx: finger sensor, SpO2, PLET
Module 1
EMG: 2 channels, band–pass 
filtering
SCL: 1 channels, band–pass filtering
Module 2
NIBP: arm cuff, SBP, DBP, MAP, 
HR, reference for CNAP
TEMP: 2 places on body
Module 3
REO: neck, chest, and limb leads, 
SV, Z0, ACI
Module 4
EEG: differential leadas, 3 channels, 
band–pass filtering
Module 5
CAPNO: nasal cannula, cCO2, CO2, 
EtCo2, RR
Module 6
NIRS 1: 2 channels
Module 7
CNAP: finger cuff, SBP, DBP, 
MAP, HR
Module 8
NIRS 2: 6 channels, frontal lobe, motor cortex, 
visual cortex (left and right hemispheres)
In-house designed NIRS module
(b)
(c)
(a)

Dziuda et al. 
Research Protocol:  Part I 
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application complies with the requirements of the standards harmonised with Directive 
93/42/EEC and has been certified with a CE marking. 
 
The prototype system developed at technology readiness level 9 was deployed in a room with 
medical approvals, and prepared for pilot-based studies. A photograph of a subject being 
examined with the prototype of the ORTHO-LBNP system is shown in Fig. 5 (a). A neoprene 
skirt similar to those used in kayak sports was applied to seal the space between the subject and 
the edge of the LBNP chamber. The sealing skirt was customised by the manufacturer so that 
two ropes can be attached to it to prevent the skirt from sliding off the hips when negative 
pressure is applied. The ropes were fastened on the other side to the stands mounted at the head 
of the table. For a continuous recording of arterial pressure acquired from the subject’s finger 
at the heart level, an adjustable handrest was designed and installed on top of the LBNP 
chamber. 
 
A unique feature of the prototype system is the ability to carry out experiments with a saddle 
on which the patient is placed for minimising the impact of the footboard (Fig. 5 (b)) on the 
subject’s legs. In this way some researchers tried to reduce the leg muscle tension and weaken 
the blood pushing out toward the upper part of the body [20]-[22]. Thus the seat may intensify 
the effect of blood pooling in the lower extremities and we decided that the prototype system 
would be equipped with a removable saddle as an option for research applications, as shown 
in Fig. 5 (c). 
 
 
Fig. 5.  Photographs of the prototype system: a (a) subject during an examination, the 
(b) open LBNP chamber with the footboard, (c) optionally mounted saddle. 
 
(a)
Neoprene 
waist seal
Mattress
Tilt table
Waist seal 
supportive ropes
Adjustable handrest
NIRS optodes
Rope fixing stands
ECG electrodes
REO electrodes
SCL 
electrodes
POx finger 
clip sensor
NIBP 
arm cuff
CNAP module
Fiber guide
Chamber 
lock
Opening 
handle
Nasal cannula
LBNP 
chamber
(b)
(c)

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Research Protocol:  Part I 
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Research scenarios 
Scenario I 
Scenario I will be composed of seven phases, shown in Fig. 6, which can be characterised as: 
(1) 300-s check before the stimuli, (2) LBNP is applied stepwise with 11.1 mmHg/15 s 
decrement to -100 mmHg, and then this value is sustained for 120 s, (3) 180-second phase of 
rest between stimuli, (4) 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector 
(-30°), (5) 180-second phase of rest between stimuli, (6) 75°-HUT (5°/s) accompanied by an 
exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is 
sustained for 120 s during HUT, and (7) 120-s check after the stimuli. 
 
 
Fig. 6.  Tilt and LBNP profiles in 24-min Scenario I. 
 
Scenario II 
Scenario II will be composed of seven phases, shown in Fig. 7, which can be characterised as: 
(1) 120-s check before the stimuli, (2) 75°-HUT (45°/s) for 60 s after a 3-s reversing of the 
gravity vector (-30°), (3) 180-second phase of rest between stimuli, (4) LBNP decreases 
linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s, (5) 180-second 
phase of rest between stimuli, (6) push-pull, i.e., 3  75°-HUT (45°/s) preceded by -30°-HDT 
(45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 
mmHg/s, and then this value is sustained for 30 s during HUT, and (7) 120-s check after the 
stimuli. 
 
 
Fig. 7.  Tilt and LBNP profiles in 16-min Scenario II. 
-40
-20
0
20
40
60
80
100
0
240
480
720
960
1200
1440
Tilt (°)
Time (s)
-120
-100
-80
-60
-40
-20
0
0
240
480
720
960
1200
1440
LBNP (mmHg)
Time (s)
1
2
3
4
5
6
7
-40
-20
0
20
40
60
80
0
120
240
360
480
600
720
840
960
Tilt (°)
Time (s)
-120
-100
-80
-60
-40
-20
0
0
120
240
360
480
600
720
840
960
LBNP (mmHg)
Time (s)
1
2
3
4
5
6
7

Dziuda et al. 
Research Protocol:  Part I 
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The pilot study will be carried out in an isolated room in the presence of a physician 
(physiologist), a paramedic and an ORTHO-LBNP system operator. The paramedic will 
prepare the subject for the study by placing on his/her body electrodes and measuring sensors 
that will be removed after completion of the study. The subject will be asked to close his/her 
eyes during the tests and to place his/her hands on the rest. In order to cause the least 
disturbance, no conversation will be held with the subject. Only if disturbing symptoms will 
occur, will the subject immediately report this to the personnel. The physician will 
systematically be observing the subject’s cardiogram, his/her HR, CNAP wave, and systolic 
and diastolic blood pressure (SBP and DBP, respectively) in comparison with the changing tilt 
of the table and negative pressure in the chamber. Any time, at the request of the subject or on 
the instruction of the doctor, the operator will interrupt the tests. The tilt table then will return 
to the Trendelenburg position if interruption occur during HUT and/or LBNP stimuli, or 
horizontal position if interruption occur during HDT stimulus. At the same time atmospheric 
pressure will be resumed in the chamber. 
 
 
Safety Considerations 
The subjects will be informed of possible presyncope symptoms that may occur during the tilt 
and/or LBNP exposure, with an emphasis on the prompt notification of any symptoms. Prior 
to the exposure, a shortened medical survey will be performed, including a subjective 
examination for possible contraindications to the exposure, and a physical examination, i.e., 
RR and HR measurements in sitting and standing positions. Once the subject is placed in the 
LBNP chamber, their resting ECG as well as SBP and DBP will be assessed. 
 
Both tilt and LBNP tests are relatively safe, but complications in the form of ventricular 
arrhythmias or asystole are known. Therefore, at the time of the study, the presence of trained 
medical personnel, consisting of a physician and paramedic, shall be provided. The following 
rescue equipment will be available: 
1. Ambu self-inflating bag with connector to supply oxygen. 
2. Oxygen cylinder with reducer. Check the filling status before exposure! 
3. Automatic defibrillator. Check the battery charge before exposure! 
4. Anti-shock kit in accordance with the Executive Regulation of the Minister of Health of 
24 September 2013 on the guaranteed benefits in the area of primary healthcare (Journal 
of Laws, 2013, item 1248) and Law of 6 September 2001 - Pharmaceutical Law (Journal 
of Laws, 45, 2008, item 271) with amendments. The detailed composition of the anti-shock 
kit is presented in Appendix A to this research protocol. 
 
If presyncope syndromes are present, immediately stop the HUT and/or LBNP exposition and 
move the tilt table to the Trendelenburg position (tilt angle of -16°). There is a difference in the 
way of handling push-pull simulations. The procedure depends on the study phase. For +Gz 
exposures, i.e., HUT and/or LBNP, immediately stop the LBNP exposure (if used) and move 
the tilt table to the Trendelenburg position. In the event of any feeling of discomfort by the 
subject during -Gz exposures, i.e., HTD, the orthostatic exposition should be discontinued and 
returned to the horizontal position of the tilt table (tilt angle of 0°). 
 
In case of asystole or ventricular arrhythmias in the form of ventricular tachycardia or 
ventricular fibrillation, the resuscitation procedure should be implemented in accordance with 
the adult advanced life support (ALC) algorithm: 
1. Check whether the victim reacts, whether breathing or not, or does not have single sighs. 

Dziuda et al. 
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2. Inform the MIAM resuscitation team at the Intensive Care Unit - tel. 621-852-654. 
3. Start a cardiopulmonary resuscitation according to scheme 30:2, i.e., provide 30 chest 
compressions, followed by two breaths. 
4. Supply oxygen to the self-inflating bag used for resuscitation. 
5. Connect the defibrillator/monitor, minimise resuscitation intervals. 
6. Rate the heart rhythm. 
7. Perform defibrillation if there is a ventricular fibrillation (VF) or ventricular tachycardia 
(VT) without pulse. Follow the procedure given by the automatic defibrillator. 
8. Immediately take cardiopulmonary resuscitation (CPR) for 2 minutes, minimise 
resuscitation intervals. 
9. Rate the heart rhythm, continue ALC. 
 
 
Follow-Up 
After the study, on the same day, it is advisable not to drive or fly an aircraft. 
 
 
Data Management 
MIAM is both a research institute and medical centre, where data management and information 
security are provided in accordance with the ISO IEC 27001 standard. A copy of the certificate 
is included as Appendix B. 
 
 
Statistical Analysis Plan 
The statistical analysis of the results will be performed in two aspects: 
 
1. Differentiation of the study phases (scenario I). 
The statistical analysis will be directed toward estimating how separate tilt and LBNP 
stimuli and the complex stimulus affect basic physiological parameters, i.e., HR, inter-beat 
interval (IBI), SBP, DBP, mean arterial pressure (MAP), stroke volume (SV), cardiac 
output (CO), left ventricular ejection time (LVET), rate pressure product (RPP), and total 
peripheral resistance (TPR), calculated using the ECG and CNAP signals. The mean 
values of the individual parameters for the test group (experimental arm 1), along with 
standard deviations and standard errors, will be determined for each experiment phase, and 
their changes will be described in relation to the check before the stimuli (phase 1). Finally, 
significances of these changes will be shown. 
 
2. Differentiation of the study phases and differentiation of subjects with various level of 
flight experience (scenario II). 
The statistical analysis will be directed toward estimating how separate tilt and LBNP 
stimuli and the combined stimulus as well as the level of flight experience affect HR, IBI, 
SBP, DBP, MAP, SV, CO, LVET, RPP, and TPR, calculated using the ECG and CNAP 
signals, base transthoracic impedance (Z0_T), first derivative of transthoracic impedance 
(dZ/dt_T), base transcephalic impedance (Z0_H), and first derivative of transcephalic 
impedance (dZ/dt_H), calculated using the REO signals, changes in oxygenated 
haemoglobin (ΔC_HbO2), changes in deoxygenated haemoglobin (ΔC_Hb), and changes 
in total haemoglobin (ΔC_tot), calculated using NIRS signals. The mean values of the 

Dziuda et al. 
Research Protocol:  Part I 
ORTHO-LBNP 
14 
individual parameters for the test group (experimental arm 2), along with standard 
deviations and standard errors, will be determined for each experiment phase, and their 
changes will be described in relation to the initial level in phase 1. Additionally, descriptive 
statistics of the above-mentioned physiological parameters obtained by the subjects with 
flight experience in relation to the parameters obtained by the subjects without flight 
experience, will be performed Finally, significances of changes in physiological 
parameters along with the subsequent phase of the research work and the level of flight 
experience will be presented. 
 
We do not have a preferred statistical method at the time of preparing the research protocol 
and planning the pilot study. However, we expect negative results of the normal 
distribution test and hence the use of nonparametric statistical tests, e.g., the 
Friedman-Kendall analysis of variance for multiple dependent samples. A more detailed 
description of the used statistical analysis and level of significance will be included in 
publications, and the PRS record will be complemented with the results. 
 
 
Quality Assurance 
MIAM has a quality management certificate based on the ISO 9001:2008 and AQAP 
2120:2009 requirements. Moreover, high quality of the research carried out at the institute has 
been confirmed by the certificates issued by the US Air Force in the following areas: 
­ aerospace physiology and centrifuge training program, 
­ acceleration physiology and centrifuge training program. 
 
Copies of the certificates are included as Appendix B. 
 
 
Expected Outcomes of the Study 
During the implementation of both research scenarios, all signals/parameters that can be 
acquired by the medical monitoring subsystem will be recorded. However, in scenario I the 
main emphasis will be placed on the analysis of basic physiological parameters, i.e., HR, 
inter-beat interval (IBI), SBP, DBP, mean arterial pressure (MAP), stroke volume (SV), cardiac 
output (CO), left ventricular ejection time (LVET), rate pressure product (RPP), and total 
peripheral resistance (TPR), calculated using the ECG and CNAP signals. The latest literature 
shows that the analysis of basic physiological parameters, e.g., heart rhythm and blood 
pressure, enables for predicting orthostatic hypotension [23] and reveals precursory signs of 
syncope [24]. Our intention is to verify the behaviour of a group of cadets experiencing 
accelerations on a regular basis who are subject to tests in a device of a novel design. We expect 
that a stronger stimulus will cause greater changes in the values of the analysed physiological 
parameters. Among the stimuli used, the strongest one should be HUT accompanied by LBNP. 
The analysis should indicate these physiological parameters that should be taken into account 
in the development of an orthostatic tolerance index (OTI). 
 
The results of scenario II will be focused not only on the impact of the stimuli, but will also be 
analysed in terms of the distinguishing of subjects with different level of flight experience and 
quantifying an examined person’s propensity to endure gravitational stimuli. Both analysis of 
basic physiological parameters as well as analysis of indices determining the level of 
oxygenation of brain areas acquired with the in-house-designed NIRS module will be 

Dziuda et al. 
Research Protocol:  Part I 
ORTHO-LBNP 
15 
performed. It is expected that greater changes in brain oxygenation indices will be seen in the 
subjects without flight experience than in active pilots that have undergone a training 
improving their G-tolerance. 
 
We anticipate that new indicators will be proposed to enable an objective assessment of the 
predispositions to pursue a military pilot career. Finally, this should make the selection 
procedures in military aviation easier. 
 
At least two manuscripts, one containing the results of scenario I, the other containing the 
results of scenario II, will be submitted for publication. 
 
 
Dissemination of Results and Publication Policy 
The results will be first reported via the National Centre of Research and Development, Poland, 
to the Ministry of National Defence, Poland. The Ministry will decide whether to implement 
the ORTHO-LBNP system into the selection process of candidates for military pilots. 
 
The publications will be prepared under the leadership of the PI. The PI decides on the author 
lists. Only persons who gave the conception of the prototype system, modelled the tilt table 
and LBNP chamber, designed and constructed the prototype system, coordinated certification 
procedures, programmed the tilt and LBNP profiles, designed the experimental protocol, 
coordinated the pilot study, processed data for analysis, analysed and verified data, and 
interpreted the results, can be included on the author lists. The person who contributes the most 
to the preparation of the manuscript will be its first author. If the PI is not the author of the 
largest contribution, he will be acknowledged as the last author of the article. 
 
All authors will review the manuscripts and accept their final version. 
 
 
Duration of the Project 
Duration of the project is December 2012 - February 2018. 
 
Realisation of the research scenarios is scheduled for February 2017 - February 2018. 
Problems Anticipated 
A comprehensive risk analysis has been developed for the project, identifying the following 
hazard areas: 
1. Energy threats (39 risks). 
2. Biological and chemical hazards (7 risks). 
3. Environmental hazards (8 risks). 
4. Risks arising from the release of energy, substances and the selection of subassemblies 
(8 risks). 
5. Risks associated with the use of the product (27 risks). 
6. Risks related to usability (16 risks). 
7. Hazards of damage and malfunction (11 risks). 
8. Risks associated with embedded software (8 risks). 
9. Risks associated with SOUP software (2 risks). 
10. Risks associated with PC software (7 risks). 

Dziuda et al. 
Research Protocol:  Part I 
ORTHO-LBNP 
16 
Each of the identified risks can be minimized to an acceptable level. None of them is a risk 
determined as certain. 
 
The risk analysis is not part of this document due to its extensiveness. 
 
 
Project Management 
The project is managed in accordance with the PRINCE2 methodology. The PI manages the 
Team Leaders who come from the member institutions implementing the project listed in the 
General Information section. The PI shall consult and report the results of the project to the 
Steering Committee, in which each of the member institutions has one representative. 
 
 
Ethics 
Tilt and LBNP test are recognised as relatively safe interventions, however ventricular 
arrhythmias or asystole can appear. For decades, research works involving military pilots have 
been conducted at MIAM. Most of these studies have been interfered with the cardiovascular 
system to a greater or lesser extent. Therefore, the institute has qualified personnel to conduct 
such a research, an advanced rescue team and the ethics committee that deals with studies in 
real or simulated conditions. 
 
Potential subjects will be informed on the study at least 30 days before the planned study. Those 
who are initially interested in the study participation will receive a copy of the research protocol 
for acquainting. They should decide at least 15 days before the beginning of the planned study 
and inform the PI or a study coordinator appointed by the PI. Just before the study, the subjects 
will receive two copies of the informed consent form to acquaint and sign. One of the signed 
copies is for the subject and the other is for the sponsor. 
 
 
Informed Consent Forms 
A copy of the informed consent form in English is included as Appendix C. 
Literature 
[1] Voge, V. M. Acceleration forces on the human subject. Aviat. Space Environ. Med. 9, 
970-980 (1980). 
[2] Creer, B. Y., Smedal, H. A. & Wingrove, R. C. Centrifuge study of pilot tolerance to 
acceleration and the effects of acceleration on pilot performance. NASA Technical Note 
D-337 https://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/19980223621.pdf (1960). 
[3] Stevens, P. M. & Lamb, L. E. Effects of lower body negative pressure on the 
cardiovascular system. Am. J. Cardiol. 16, 506-515, doi: 10.1016/0002-9149(65)90027-5 
(1965). 
[4] Gilbert, C. A. & Stevens, P. M. Forearm vascular responses to lower body negative 
pressure and orthostasis. J. Appl. Physiol. 21, 1265-1272 (1966). 
[5] Wolthuis, R. A., Bergman, S. A. & Nicogossian, A. E. Physiological effects of locally 
applied reduced pressure in man. Physiol. Rev. 54, 566-595 (1974). 
[6] Alvim, K. M. Greyout, blackout, and G-loss of consciousness in the Brazilian Air Force: 
a 1991-92 survey. Aviat. Space Environ. Med. 66, 675-677 (1995). 

Dziuda et al. 
Research Protocol:  Part I 
ORTHO-LBNP 
17 
[7] Dosel, P., Hanousek, J., Petricek, J. & Cettl, L. LBNP and push-pull effect. J. Gravit. 
Physiol. 14, 135-136 (2007). 
[8] Sheriff, D. D., Nådland, I. H. & Toska, K. Retrograde arterial leg blood flow during 
tilt-back from a head-up posture: importance of capacitive flows when arterial pressure 
changes. J. Appl. Physiol. 108, 533-537, doi: 10.1152/japplphysiol.01184.2009 (2010). 
[9] Montgomery, L. D., Parmet, A. J. & Booher, C. R. Body volume changes during simulated 
microgravity: 
auditory changes, segmental fluid redistribution, and regional 
hemodynamics. Ann. Biomed. Eng. 21, 417-433, doi: 10.1007/BF02368634 (1993). 
[10] Zhang, L.-F. Vascular adaptation to microgravity: what have we learned? J. Appl. Physiol. 
91, 2415-2430 (2001). 
[11] Morita, H., Abe, C. & Tanaka, K. Long-term exposure to microgravity impairs 
vestibule-cardiovascular reflex. Sci. Rep. 6, 33405, doi: 10.1038/srep33405 (2016). 
[12] C. May et al. Affect of microgravity on cardiac shape: comparison of pre- and in-flight 
data to mathematical modelling. J. Am. Coll. Cardiol. 63, A1096 (2014). 
[13] Coats, B. W. & Sharp, M. K. Simulated stand tests and centrifuge training to prevent 
orthostatic intolerance on Earth, moon, and Mars. Ann. Biomed. Eng. 38, 1119-1131, doi: 
10.1007/s10439-010-9943-3 (2010). 
[14] Lategola, M. T., Lyne, P. J. & Burr, M. J. Cardiorespiratory assessment of 24-hour 
crash-diet effects on altitude, +Gz, and fatigue tolerances. Aviat. Space Environ. Med. 53, 
201-209 (1982). 
[15] Polese, A., Sandler, H. & Montgomery, L. D. Hemodynamic responses to seated and 
supine lower body negative pressure: comparison with +Gz acceleration. Aviat. Space 
Environ. Med. 63, 467-475 (1992). 
[16] Watenpaugh, D. E. et al. Human cutaneous vascular responses to whole-body tilting, Gz 
centrifugation, 
and 
LBNP. 
J. 
Appl. 
Physiol. 
96, 
2153-2169, 
doi: 
10.1152/japplphysiol.00198.2003 (2004). 
[17] Skibniewski, F. W. et al. Preliminary results of the LF/HF ratio as an indicator for 
estimating difficulty level of flight tasks. Aerosp. Med. Hum. Perform. 86, 518-523, doi: 
10.3357/AMHP.4087.2015 (2015). 
[18] Śmietanowski, M., Cudnoch-Jędrzejewska, A. & Dziuda, Ł. Application of orthostatic test 
and lower body negative pressure in investigation of circulatory reflexes in humans. Folia 
Cardiol. 10, 283-287, doi: 10.5603/FC.2015.0050 (2015). 
[19] Sobotnicki, A. et al. Bearing position changing system, preferably of the verticalisation 
table. Polish Patent 224837 (2014). 
[20] Shoemaker, J. K., Hogeman, C. S. & Sinoway, L. I. Contributions of MSNA and stroke 
volume to orthostatic intolerance following bed rest. Am. J. Physiol. 277, R1084-R1090 
(1999). 
[21] Ogoh, S. et al. Carotid baroreflex responsiveness to head-up tilt-induced central 
hypovolaemia: 
effect 
of 
aerobic 
fitness. 
J. 
Physiol. 
551, 
601-608, 
doi: 
10.1113/jphysiol.2003.046029 (2003). 
[22] Akimoto, T. et al. Enhanced open-loop but not closed-loop cardiac baroreflex sensitivity 
during orthostatic stress in humans. Am. J. Physiol. Regul. Integr. Comp. Physiol. 301, 
R1591-R1598, doi: 10.1152/ajpregu.00347.2011 (2011). 
[23] Sun, Z. et al. Prediction of orthostatic hypotension in multiple system atrophy and 
Parkinson disease. Sci. Rep. 6, 21649, doi: 10.1038/srep21649 (2016). 
[24] Makowiec, D., Graff, B. & Struzik, Z. R. Multistructure index characterization of heart 
rate and systolic blood pressure reveals precursory signs of syncope. Sci. Rep. 7, 419, doi: 
10.1038/s41598-017-00354-x (2017). 

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Research Protocol:  Part II 
ORTHO-LBNP 
18 
Budget 
The project is supported by the resources of the National Centre of Research and Development 
(NCRD), Poland, within the framework of the Program for National Defence and Security. 
 
Information on the budget level is not available due to a military character of the project. 
 
 
Other support for the Project 
No other funds. 
 
 
Collaboration with other scientists or research institutions 
Medical University of Warsaw 
1. Maciej Śmietanowski, M.D., Ph.D. (physiologist) 
2. Liana Puchalska, M.D., Ph.D. (physiologist) 
 
 
Links to other projects 
ID 
Project No. 
Title 
Source of 
funding 
Duration 
Publications 
1. 
03/WNiI/2007/IWSZ 
Improvement of examinations 
in real flight conditions of 
physiological and 
psychological parameters in 
cadets and pilots retrained on 
new types of aircraft for the 
assessment of environment 
and training progress 
Ministry of 
National 
Defence, 
Poland 
2007–2013 
1. DOI: 
10.3357/AMHP.4
087.2015 
 
 
Curriculum Vitae of investigators 
PI's Curriculum Vitae 
Personal information 
Forename and family name: Łukasz Dziuda 
Date of birth: 
November 21, 1976 
Nationality: 
Polish 
ORCID: 
0000-0003-1816-4604 
URL for web site:  
http://www.wiml.waw.pl/?q=pl/Lukasz_Dziuda 
 
https://www.researchgate.net/profile/Lukasz_Dziuda 
 
Education 
2014 
D.Sc.: Nałęcz Institute of Biocybernetics and Biomedical Engineering (IBBE) of 
the Polish Academy of Sciences (PAS), Poland 
2007  
Ph.D.: Department of Electronic and Electrical Engineering, University of 
Strathclyde, UK 
 
 
Supervisor: Professor Sir Jim McDonald, BSc, MSc, PhD, DSc, CEng 

Dziuda et al. 
Research Protocol:  Part II 
ORTHO-LBNP 
19 
2000 
M.Ss.: Department of Electrical Engineering, Lublin University of Technology, 
Poland 
 
Current position 
2017– 
Associate Professor, Head of the Department of Flight Simulator Innovations, 
Military Institute of Aviation Medicine (MIAM), Poland 
 
Previous positions 
2015–2016 Associate Professor, Head of the Creative Neuro Science Laboratory (CNS Lab), 
IBBE PAS, Poland 
2013–2014 Research Fellow, Head of the LBNP Laboratory, Technical Department of 
Aeromedical Research and Flight Simulators, MIAM, Poland 
2008–2013 Research Fellow, Leader of the Medical Electronics Group, Department of 
Aviation Bioengineering, MIAM, Poland 
2005–2007 Research Assistant, Leader of the Medical Electronics Group, Department of 
Aviation Bioengineering, MIAM, Poland 
2004 – 2005 Temporary Assistant, Department of Electronic and Electrical Engineering, 
University of Strathclyde, UK 
 
Fellowships 
2000–2004 Academic Visitor, Department of Electronic and Electrical Engineering, 
University of Strathclyde, UK 
 
Institutional responsibilities 
2000– 
Representative of MIAM, Polish Technological Platform on Photonics, Poland 
 
Commissions of trust 
2014– 
Scientific Council, MIAM, Poland (Deputy Chairman since 2016) 
2014– 
Ethic Committee, MIAM, Poland 
2012– 
Reviewer of Project Applications, National Centre for Research and 
Development, Poland 
 
Web of Science 
h-index 
10 
Publications: 27 
Citations: 
168 (without self-citations) 
 
Other 
Patents: 
3 
Scholarship of the Foundation for Polish Science 
PRINCE2® Foundation certificate 
 
Other investigators 
Military Institute of Aviation Medicine 
1. Franciszek W. Skibniewski, Ph.D. (expert in the field of aviation bioengineering) 
2. Krzysztof Kowalczuk, M.D., Ph.D. (expert in the field of aviation medicine) 
3. Paulina Baran, Ph.D. (psychologist) 
4. Mariusz Krej, M.Sc. (programmer) 
5. Sylwester Guzowski, M.Sc. (programmer) 
6. Marcin Strojek, M.Sc. (paramedic) 

Dziuda et al. 
Research Protocol:  Part II 
ORTHO-LBNP 
20 
 
Institute of Medical Technology and Equipment 
1. Adam Gacek, D.Sc., Ph.D. (biomedical engineer) 
2. Aleksander Sobotnicki, M.Sc. (electronic engineer) 
3. Mariusz Sobiech, M.Sc. (constructor) 
 
Nałęcz Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of 
Sciences 
1. Adam Liebert, Full Professor, D.Sc., Ph.D. (expert in the field of biomedical engineering) 
2. Roman Maniewski, Full Professor, D.Sc., Ph.D. (expert in the field of biomedical 
engineering) 
3. Anna Gerega, Ph.D. (constructor) 
4. Stanisław Wojtkiewicz, Ph.D. (constructor) 
5. Piotr Sawosz, Ph.D. (constructor) 
 
Polish Air Force Academy 
1. Jan Rajchel, D.Sc., Ph.D. (pilot) 
2. Marek Bylinka, Ph.D. (pilot) 
3. Michał Burek, Ph.D. (pilot) 
 
ETC-PZL Aerospace Industries Sp. z o.o. 
1. Anna Brzozowska, M. Sc. (constructor) 
2. Piotr Kwaśny, M. Sc. (constructor) 
3. Janusz Gajda, M. Sc. (constructor) 
 
 
Research activities of the PI 
ID 
Project No. 
Title 
Source of 
funding 
Duration 
Involvement 
1. 
DOBR/0052/R/ID1/2012/03 
Development of the ORTHO-
LBNP system for research and 
training of Polish Air Force 
pilots under conditions of 
ischemic hypoxia and 
orthostatic stress 
NCRD 
2012–2018 
60% 
2. 
PBS3/B9/41/2015 
Optoelectronic patient 
monitoring in magnetic 
resonance 
NCRD 
2015–2018 
20% 
3. 
PBS3/B9/29/2015 
Detector of early fatigue 
symptoms as an element of 
improved driving safety 
NCRD 
2015–2018 
10% 
4. 
PBS3/B9/37/2015 
System of evacuation and 
rescue of victims in natural 
disasters 
NCRD 
2015–2017 
10% 
 
 
Financing and Insurance 
All diagnostic surveys and pilot studies performed at MIAM are insured. 

Dziuda et al. 
Research Protocol:  Appendix A 
ORTHO-LBNP 
21 
Appendix A 
List of medicinal products being part of the anti-shock kit, which 
may be given by a physician 
 
1. Aminophyllinum 0,25 g - 10 amp. a 10 ml. 
2. Antazolini hydrochloridum 50 mg/ml - 5 amp. a 2 ml. 
3. Aqua pro inj. - 5 amp. a 5 ml. 
4. Atropini sulfas 1 mg - 10 amp. a 1 ml. 
5. Calcii chloridum or Calcii gluconas - solutions 10% - 10 amp. a 10 ml. 
6. Clonazepamum a 1 mg - 10 amp. a 1 ml. 
7. Dopamini hydrochloridum 4% - 10 amp. a 5 ml. 
8. Epinephrinum a 1 mg - 10 amp. a 1 ml. 
9. Furosemidum 20 mg - 5 amp. a 2 ml. 
10. Glucosum 40% 2 - 10 amp. a 10 ml. 
11. Glyceroli trinitras aerosol - 1 pack. 
12. Hydrocortisonum 250 mg - 5 phial a 250 mg + 5 amp. diss. a 2 ml or Methylprednizolonum 
40 mg -1 phial a 40 mg + 1 amp. diss., Methylprednizolonum 125 mg - 1 phial a 125 mg 
+ 1 amp. diss., Methylprednizolonum 250 mg - 1 phial a 250 mg + 1 amp. diss., 
Methylprednizolonum 500 mg - 1 phial a 500 mg + 1 amp. diss., Methylprednizolonum 
1000 mg - 1 phial a 1000 mg + 1 amp. diss. 
13. Lidocaini hydrochloridum 2 % - 10 amp. a 2 ml. 
14. Metamizolum natricum 2,5 g - 5 amp. a 5 ml. 
15. Metoprololi tartas 1 mg/ml - 5 amp. a 5 ml. 
16. Morphini sulfas 20 mg/1 ml - 2 amp. a 1 ml. 
17. Naloxoni hydrochloridum 0,4 mg/1 ml - 10 amp. a 1 ml. 
18. Natrii chloridum 0.9% - 10 amp. a 10 ml. 
19. Natrii hydrocarbonas 8.4-% solution for intravenous injection - 5 amp. a 20 ml. 
20. Salbutamoli sulfas aerosol 100 mcg/dose - 1 pack. 
21. Salbutamoli sulfas a 0,5 mg - 10 amp. a 1 ml. 
22. Thiethylperazini dimaleas a 6,5 mg/ml - 5 amp. a 2 ml. 
23. Tramadoli hydrochloridum 50 mg/ml - 5 amp. a 2 ml. 
24. Verapamili hydrochloridum 2,5 mg/ml - 5 amp. a 2 ml. 
 
Infusion fluids: 
1. Calcii chloridum + Kalii chloridum + Natrii chloridum (Ringer's fluid) - 1 pack a 250 ml. 
2. Glucosum 5 % - 1 pack a 500 ml. 
3. Glucosum 10 % - 1 pack a 500 ml. 
4. Mannitolum 20 % - 1 pack a 250 ml. 
5. Natrii chloridum 0,9 % - 2 pack a 500 ml. 
 
 

Dziuda et al. 
Research Protocol:  Appendix A 
ORTHO-LBNP 
22 
 
List of medicinal products being part of the anti-shock kit, which 
may be given by a paramedic 
 
1. Antazolini hydrochloridum 50 mg/ml - 5 amp. a 2 ml. 
2. Aqua pro inj. - 5 amp. a 5 ml. 
3. Atropini sulfas 1 mg - 10 amp. a 1 ml. 
4. Calcii chloridum or Calcii gluconas - solutions 10% - 10 amp. a 10 ml. 
5. Hydrocortisonum 250 mg - 5 phial a 250 mg + 5 amp. diss. a 2 ml or Methylprednizolonum 
40 mg -1 phial a 40 mg + 1 amp. diss., Methylprednizolonum 125 mg - 1 phial a 125 mg 
+ 1 amp. diss., Methylprednizolonum 250 mg - 1 phial a 250 mg + 1 amp. diss., 
Methylprednizolonum 500 mg - 1 phial a 500 mg + 1 amp. diss., Methylprednizolonum 
1000 mg - 1 phial a 1000 mg + 1 amp. diss. 
6. Epinephrinum a 1 mg - 10 amp. a 1 ml. 
7. Glucosum 20% - 10 amp. a 10 ml. 
8. Natrii chloridum 0.9% - 10 amp. a 10 ml. 
 
Infusion fluids: 
1. Calcii chloridum + Kalii chloridum + Natrii chloridum (Ringer's fluid) - 1 pack a 250 ml. 
2. Glucosum 5 % - 1 pack a 500 ml. 
3. Glucosum 10 % - 1 pack a 500 ml. 
4. Natrii chloridum 0,9 % - 2 pack a 500 ml. 
 
 

Dziuda et al. 
Research Protocol:  Appendix B 
ORTHO-LBNP 
23 
Appendix B 
(Copies of certificates) 
 
 
 
 
 
 
 
 
 
 

Dziuda et al. 
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24 
 
 
 
 
 
 
 
 

Dziuda et al. 
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25 
Appendix C 
(Informed consent form in English) 
 
 
 
INFORMED  CONSENT  FORM 
 
Forename and family name, age:  …………………………………………………………… 
 
Address:  ……………………………………………………………………………………… 
 
Protocol title:  Evaluation of a prototype system for generating conditions of orthostatic 
hypotension and blood pooling in the lower body. 
 
I hereby declare that I have been informed on the purpose of the intended research and the 
manner in which it is carried out. I understand what it is supposed to be and what my consent 
is for. I have been informed that I may refuse to participate in the study or withdraw the consent 
at any time, also during the study. 
 
I express my informed consent to participate in the study, which is described on the back of 
this form. Additionally, I agree that in the case of accidental detection of irregularities during 
the study, the information about the need to repeat the case study will be forwarded to the 
Military Medical Aviation Commission. 
 
I gave this consent in the presence of the witness. 
 
 
Place and date:  ........................................... 
 
 
 
........................................... 
Subject’s signature 
............................................... 
PI’s signature 
 
 
 

Dziuda et al. 
Research Protocol:  Appendix C 
ORTHO-LBNP 
26 
 
 
INFORMATION  ON  THE  STUDY 
Protocol title:  Evaluation of a prototype system for generating conditions of orthostatic 
hypotension and blood pooling in the lower body. 
 
Purpose of the study:  Checking how the tilt and LBNP stimuli affect the cardiovascular system 
and cerebral oxygenation. 
 
Study design: 
1. Shortened medical survey including a subjective examination for possible contraindications 
to the tilt and/or LBNP exposures and a physical examination, i.e., respiration rate and heart 
rate measurements in sitting and standing positions. 
2. Study using the ORTHO-LBNP system, i.e., a prototype device consisting of a tilt table to 
generate orthostatic stress and an underpressure chamber to extort pooling of blood in the 
lower extremities, as during +Gz accelerations. 
 
Study description: 
The study is carried out in an isolated room in the presence of a physician (physiologist), 
a paramedic and an ORTHO-LBNP system operator. The paramedic prepares the subject for 
the study by placing on his/her body electrodes and measuring sensors that will be removed 
after completion of the study. The subject is asked to close his/her eyes during the study and to 
place his/her hands on the rest. In order to cause the least disturbance, no conversation is held 
with the subject. Only if disturbing symptoms will occur, will the subject to immediately report 
this to the personnel. The physician is systematically observing the subject’s cardiogram, 
his/her heart rhythm, continuous blood pressure wave, and systolic and diastolic blood pressure 
in comparison with the changing tilt of the table and negative pressure in the chamber. Any 
time, at the request of the subject or on the instruction of the doctor, the operator will interrupt 
the tests. The tilt table then will return to the Trendelenburg position or horizontal position, 
depending on the study phase, and atmospheric pressure will be resumed in the chamber. 
 
Additional information: 
All devices used in the study meet the applicable safety standards and are approved for testing 
in humans. A short-term psychological survey with the use of the UWIST Mood Adjective 
Checklist (UMACL) is allowed to be performed before and after the ORTHO-LBNP exposure. 
After the study, on the same day, it is advisable not to drive or fly an aircraft. 
 
 
Place and date:  ........................................... 
 
 
 
 
........................................... 
 
Subject’s signature