Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Medical Technology and Equipment | UNKNOWN |
| Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences | OTHER |
| Polish Air Force Academy | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimuli of slowly increasing intensities | Experimental |
|
|
| Stimuli of rapidly increasing intensities | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head up tilt (HUT) | Other | Model of -Gz: HUT up to 75 degrees (maximum) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HR | Heart rate in beats per minute | 24 minutes (scenario I) |
| IBI | Inter-beat interval in seconds | 24 minutes (scenario I) |
| SBP | Systolic blood pressure in millimeters of mercury | 24 minutes (scenario I) |
| DBP | Diastolic blood pressure in millimeters of mercury | 24 minutes (scenario I) |
| MAP | Mean arterial pressure in millimeters of mercury | 24 minutes (scenario I) |
| SV | Stroke volume in milliliters | 24 minutes (scenario I) |
| CO | Cardiac output in liters per minute | 24 minutes (scenario I) |
| LVET | Left ventricular ejection time in milliseconds | 24 minutes (scenario I) |
| RPP | Rate pressure product in millimeters of mercury |
| Measure | Description | Time Frame |
|---|---|---|
| Z0_T | Base transthoracic impedance in ohms | 16 minutes (scenario II) |
| dZ/dt_T | First derivative of transthoracic impedance in ohms per second |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Łukasz Dziuda, DSc, PhD | Military Institute of Aviation Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Institute of Aviation Medicine | Warsaw | 01-755 | Poland |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 10, 2017 | Nov 16, 2017 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D007511 | Ischemia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008150 | Lower Body Negative Pressure |
| D018475 | Head-Down Tilt |
| D018667 | Tilt-Table Test |
| ID | Term |
|---|---|
| D003664 | Decompression |
| D013812 | Therapeutics |
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
Not provided
Not provided
| ETC-PZL Aerospace Industries Sp. z o.o. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Lower body negative pressure (LBNP) | Other | Model of -Gz: LBNP down to -100 mmHg (maximum) |
|
| Head down tilt (HDT) | Other | Model of +Gz: HDT down to -30 degrees (maximum) |
|
| Tilt table | Device | Range of tilt angles: -45° to +80°, rate of tilt changes: up to 45°/s |
|
| LBNP chamber | Device | Range of generated underpressure: 0 to -100 mmHg, rate of underpressure changes: up to 20 mmHg/s |
|
| 24 minutes (scenario I) |
| TPR | Total peripheral resistance in medical units | 24 minutes (scenario I) |
| 16 minutes (scenario II) |
| Z0_H | Base transcephalic impedance in ohms | 16 minutes (scenario II) |
| dZ/dt_H | First derivative of transcephalic impedance in ohms per second | 16 minutes (scenario II) |
| ΔC_HbO2 | Changes in oxygenated hemoglobin in micromolars | 16 minutes (scenario II) |
| ΔC_Hb | Changes in deoxygenated hemoglobin in micromolars | 16 minutes (scenario II) |
| ΔC_tot | Changes in total hemoglobin in micromolars | 16 minutes (scenario II) |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |