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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03354234
Date of registration:	10/11/2017
Prospective Registration:	No
Primary sponsor:	Military Institute of Aviation Medicine
Public title:	Evaluation of the ORTHO-LBNP System ORTHO-LBNP
Scientific title:	Evaluation of a Prototype System for Generating Conditions of Orthostatic Hypotension and Blood Pooling in the Lower Body
Date of first enrolment:	January 2, 2017
Target sample size:	46
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03354234
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Poland

Contacts

Name:	Lukasz Dziuda, DSc, PhD
Address:
Telephone:
Email:
Affiliation:	Military Institute of Aviation Medicine

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Orthostatic Hypotension

Ischemia

Hypoxia

Intervention(s)

Device: LBNP chamber

Device: Tilt table

Other: Head down tilt (HDT)

Other: Lower body negative pressure (LBNP)

Other: Head up tilt (HUT)

Primary Outcome(s)

IBI [Time Frame: 24 minutes (scenario I)]

LVET [Time Frame: 24 minutes (scenario I)]

RPP [Time Frame: 24 minutes (scenario I)]

HR [Time Frame: 24 minutes (scenario I)]

SBP [Time Frame: 24 minutes (scenario I)]

TPR [Time Frame: 24 minutes (scenario I)]

CO [Time Frame: 24 minutes (scenario I)]

MAP [Time Frame: 24 minutes (scenario I)]

DBP [Time Frame: 24 minutes (scenario I)]

SV [Time Frame: 24 minutes (scenario I)]

Secondary Outcome(s)

?C_tot [Time Frame: 16 minutes (scenario II)]

?C_HbO2 [Time Frame: 16 minutes (scenario II)]

?C_Hb [Time Frame: 16 minutes (scenario II)]

Z0_H [Time Frame: 16 minutes (scenario II)]

dZ/dt_T [Time Frame: 16 minutes (scenario II)]

dZ/dt_H [Time Frame: 16 minutes (scenario II)]

Z0_T [Time Frame: 16 minutes (scenario II)]

Secondary ID(s)

ORTHO-LBNP_01/2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ETC-PZL Aerospace Industries Sp. z o.o.

Institute of Medical Technology and Equipment

Polish Air Force Academy

Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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