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Evaluation of the ORTHO-LBNP System

M

Military Institute of Aviation Medicine

Status

Completed

Conditions

Hypoxia
Ischemia
Orthostatic Hypotension

Treatments

Other: Head up tilt (HUT)
Other: Head down tilt (HDT)
Other: Lower body negative pressure (LBNP)
Device: LBNP chamber
Device: Tilt table

Study type

Interventional

Funder types

Other

Identifiers

NCT03354234
ORTHO-LBNP_01/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Stimuli of slowly increasing intensities
Experimental group
Description:
1. 300-s check before the stimuli 2. LBNP is applied stepwise with 11.1 mmHg/15 s decrement to -100 mmHg, and then this value is sustained for 120 s 3. 180-second phase of rest between stimuli 4. 75°-HUT (5°/s) for 120 s after a 15-s reversing of the gravity vector (-30°) 5. 180-second phase of rest between stimuli 6. 75°-HUT (5°/s) accompanied by an exposure to an LBNP of -60 mmHg increased linearly by -4 mmHg/s, and then this value is sustained for 120 s during HUT 7. 120-s check after the stimuli
Treatment:
Device: LBNP chamber
Other: Head up tilt (HUT)
Other: Lower body negative pressure (LBNP)
Device: Tilt table
Other: Head down tilt (HDT)
Stimuli of rapidly increasing intensities
Experimental group
Description:
1. 120-s check before the stimuli 2. 75°-HUT (45°/s) for 60 s after a 3-s reversing of the gravity vector (-30°) 3. 180-second phase of rest between stimuli 4. LBNP decreases linearly by -20 mmHg/s to -100 mmHg, and then this value is sustained for 60 s. 5. 180 second phase of rest between stimuli 6. push-pull, i.e., 3 x 75°-HUT (45°/s) preceded by -30°-HDT (45°/s) and accompanied by an exposure to an LBNP of -60 mmHg decreased linearly by -20 mmHg/s, and then this value is sustained for 30 s during HUT 7. 120-s check after the stimuli
Treatment:
Device: LBNP chamber
Other: Head up tilt (HUT)
Other: Lower body negative pressure (LBNP)
Device: Tilt table
Other: Head down tilt (HDT)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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