Military Institute of Aviation Medicine
Warsaw, 01-755, Poland
NCT Number: NCT03354234
The pilot study aims to 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 maneuverable aircraft, and their syndromes include loss of color vision, loss of peripheral vision, blackout and finally G-induced loss of consciousness (G-LOC). A motorized 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 has been developed in order to obtain new knowledge on counteracting the above-mentioned effects and minimizing the risk of their occurrence. This will help optimize the selection procedures of candidates with the best physiological predispositions to work as military pilots. The system is equipped with modules for monitoring biomedical parameters of a subject, including cerebral oxygenation, which ensures their safety and provides a source of data for performing advanced analyses. The ORTHO-LBNP system has been subjected to comprehensive laboratory tests and after a successful testing is ready for a pilot study involving pilots and/or cadets of the Polish Air Force Academy (PAFA). It is anticipated that new indicators will be proposed to enable an objective assessment of the predispositions to pursue a military pilot career. The prototype system can be easily adaptable to the needs of clinical and sports medicine as well as rehabilitation.
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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Warsaw, 01-755, Poland
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 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, continuous non-invasive arterial pressure (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 physician, 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Model of -Gz: HUT up to 75 degrees (maximum)
Model of -Gz: LBNP down to -100 mmHg (maximum)
Model of +Gz: HDT down to -30 degrees (maximum)
Range of tilt angles: -45° to +80°, rate of tilt changes: up to 45°/s
Range of generated underpressure: 0 to -100 mmHg, rate of underpressure changes: up to 20 mmHg/s
Time frame: 24 minutes (scenario I)
Heart rate in beats per minute
Time frame: 24 minutes (scenario I)
Inter-beat interval in seconds
Time frame: 24 minutes (scenario I)
Systolic blood pressure in millimeters of mercury
Time frame: 24 minutes (scenario I)
Diastolic blood pressure in millimeters of mercury
Time frame: 24 minutes (scenario I)
Mean arterial pressure in millimeters of mercury
Time frame: 24 minutes (scenario I)
Stroke volume in milliliters
Time frame: 24 minutes (scenario I)
Cardiac output in liters per minute
Time frame: 24 minutes (scenario I)
Left ventricular ejection time in milliseconds
Time frame: 24 minutes (scenario I)
Rate pressure product in millimeters of mercury
Time frame: 24 minutes (scenario I)
Total peripheral resistance in medical units
Time frame: 16 minutes (scenario II)
Base transthoracic impedance in ohms
Time frame: 16 minutes (scenario II)
First derivative of transthoracic impedance in ohms per second
Time frame: 16 minutes (scenario II)
Base transcephalic impedance in ohms
Time frame: 16 minutes (scenario II)
First derivative of transcephalic impedance in ohms per second
Time frame: 16 minutes (scenario II)
Changes in oxygenated hemoglobin in micromolars
Time frame: 16 minutes (scenario II)
Changes in deoxygenated hemoglobin in micromolars
Time frame: 16 minutes (scenario II)
Changes in total hemoglobin in micromolars
Military Institute of Aviation Medicine
Other Gov
Evaluation of a Prototype System for Generating Conditions of Orthostatic Hypotension and Blood Pooling in the Lower Body
Acronym: ORTHO-LBNP
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