Clinical trial NCT03354234: Evaluation of the ORTHO-LBNP System
Official title: Evaluation of a Prototype System for Generating Conditions of Orthostatic Hypotension and Blood Pooling in the Lower Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthostatic Hypotension
Ischemia
Hypoxia
Keywords: Gz accelerations
Head up tilt (HUT) test
Lower body negative pressure (LBNP) method
Physiological parameters
Variable gravitational stimuli
Lead sponsor: Military Institute of Aviation Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Medical Technology and Equipment
name: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
name: Polish Air Force Academy
name: ETC-PZL Aerospace Industries Sp. z o.o.
First posted: 2017-11-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: HR
timeFrame: 24 minutes (scenario I)
measure: IBI
timeFrame: 24 minutes (scenario I)
measure: SBP
timeFrame: 24 minutes (scenario I)
measure: DBP
timeFrame: 24 minutes (scenario I)
measure: MAP
timeFrame: 24 minutes (scenario I)
measure: SV
timeFrame: 24 minutes (scenario I)
measure: CO
timeFrame: 24 minutes (scenario I)
measure: LVET
timeFrame: 24 minutes (scenario I)
measure: RPP
timeFrame: 24 minutes (scenario I)
measure: TPR
timeFrame: 24 minutes (scenario I)
Secondary outcomes:
measure: Z0_T
timeFrame: 16 minutes (scenario II)
measure: dZ/dt_T
timeFrame: 16 minutes (scenario II)
measure: Z0_H
timeFrame: 16 minutes (scenario II)
measure: dZ/dt_H
timeFrame: 16 minutes (scenario II)
measure: ΔC_HbO2
timeFrame: 16 minutes (scenario II)
measure: ΔC_Hb
timeFrame: 16 minutes (scenario II)
measure: ΔC_tot
timeFrame: 16 minutes (scenario II)
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Military Institute of Aviation Medicine
Study officials:
affiliation: Military Institute of Aviation Medicine
name: Łukasz Dziuda, DSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: