Evaluation of the ORTHO-LBNP System

NCT03354234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-09

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354234 on ClinicalTrials.gov