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Evaluation of the ORTHO-LBNP System

Evaluation of a Prototype System for Generating Conditions of Orthostatic Hypotension and Blood Pooling in the Lower Body

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03354234
Acronym
ORTHO-LBNP
Enrollment
46
Registered
2017-11-27
Start date
2017-01-02
Completion date
2018-02-17
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Ischemia, Orthostatic Hypotension

Keywords

Gz accelerations, Head up tilt (HUT) test, Lower body negative pressure (LBNP) method, Physiological parameters, Variable gravitational stimuli

Brief summary

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.

Detailed description

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. 1. 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 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. 2. 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. 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.

Interventions

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

DEVICELBNP chamber

Range of generated underpressure: 0 to -100 mmHg, rate of underpressure changes: up to 20 mmHg/s

Sponsors

Military Institute of Aviation Medicine
Lead SponsorOTHER_GOV
Institute of Medical Technology and Equipment
CollaboratorUNKNOWN
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
CollaboratorOTHER
Polish Air Force Academy
CollaboratorUNKNOWN
ETC-PZL Aerospace Industries Sp. z o.o.
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Pilots or cadets with flight experience * Candidates for pilots without flight experience * None alcohol 24 hours prior to the study * Written informed consent

Exclusion criteria

* Subjects with cardiovascular disorders

Design outcomes

Primary

MeasureTime frameDescription
HR24 minutes (scenario I)Heart rate in beats per minute
IBI24 minutes (scenario I)Inter-beat interval in seconds
SBP24 minutes (scenario I)Systolic blood pressure in millimeters of mercury
DBP24 minutes (scenario I)Diastolic blood pressure in millimeters of mercury
MAP24 minutes (scenario I)Mean arterial pressure in millimeters of mercury
SV24 minutes (scenario I)Stroke volume in milliliters
CO24 minutes (scenario I)Cardiac output in liters per minute
LVET24 minutes (scenario I)Left ventricular ejection time in milliseconds
RPP24 minutes (scenario I)Rate pressure product in millimeters of mercury
TPR24 minutes (scenario I)Total peripheral resistance in medical units

Secondary

MeasureTime frameDescription
Z0_T16 minutes (scenario II)Base transthoracic impedance in ohms
dZ/dt_T16 minutes (scenario II)First derivative of transthoracic impedance in ohms per second
Z0_H16 minutes (scenario II)Base transcephalic impedance in ohms
dZ/dt_H16 minutes (scenario II)First derivative of transcephalic impedance in ohms per second
ΔC_HbO216 minutes (scenario II)Changes in oxygenated hemoglobin in micromolars
ΔC_Hb16 minutes (scenario II)Changes in deoxygenated hemoglobin in micromolars
ΔC_tot16 minutes (scenario II)Changes in total hemoglobin in micromolars

Countries

Poland

Contacts

PRINCIPAL_INVESTIGATORŁukasz Dziuda, DSc, PhD

Military Institute of Aviation Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026