Evaluation of the ORTHO-LBNP System
NCT03354234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2026-03-09
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.
Conditions
- Orthostatic Hypotension
- Ischemia
- Hypoxia
Interventions
- OTHER
-
Head up tilt (HUT)
Model of -Gz: HUT up to 75 degrees (maximum)
- OTHER
-
Lower body negative pressure (LBNP)
Model of -Gz: LBNP down to -100 mmHg (maximum)
- OTHER
-
Head down tilt (HDT)
Model of +Gz: HDT down to -30 degrees (maximum)
- DEVICE
-
Tilt table
Range of tilt angles: -45° to +80°, rate of tilt changes: up to 45°/s
- DEVICE
-
LBNP chamber
Range of generated underpressure: 0 to -100 mmHg, rate of underpressure changes: up to 20 mmHg/s
Sponsors & Collaborators
-
Institute of Medical Technology and Equipment
collaborator UNKNOWN -
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
collaborator OTHER -
Polish Air Force Academy
collaborator UNKNOWN -
ETC-PZL Aerospace Industries Sp. z o.o.
collaborator UNKNOWN -
Military Institute of Aviation Medicine
lead OTHER_GOV
Principal Investigators
-
Łukasz Dziuda, DSc, PhD · Military Institute of Aviation Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-02
- Primary Completion
- 2018-02-17
- Completion
- 2018-02-17
Countries
- Poland
Study Locations
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