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Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

NCT ID: NCT01993394

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-07-31

Brief Summary

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The primary aim of this project is to get further knowledge on the effects of + Gz accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung perfusion and cardiovascular function in these conditions.

Detailed Description

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Experiments were conducted in a human centrifuge. The protocol aimed at mimicking a routine peacetime flight in combat aircraft, and included 10-min exposure to +1.4 - +3.5 Gz. Subjects were exposed three times to this sequence, breathing air, 44.5% O2 or 100% O2.

Ten volunteers wearing anti-G trousers participated in the study. The Ethics Committee Ile-de-France III and the French National Agency for Drug Safety (ANSM) approved the protocol (number 2009-A01092-55).

Three different imaging techniques, electrical impedance tomography (EIT), pulmonary ultrasound and chest SPECT/CT were used and compared. EIT enabled ventilation monitoring in the human centrifuge, whereas pulmonary ultrasound and SPECT/CT gave functional and topographical information before and after exposure to +Gz accelerations. EIT analysis focused on regional ventilation, SPECT on global lung ventilation and perfusion, CT on the presence of atelectasis, and pulmonary ultrasound analysis looked for comet tails in 64 chest areas. Arterial blood pressure was recorded continuously by finger photoplethysmography. Cardiac output and stroke volume were computed from these recordings, using three different algorithms. Echocardiography was used as reference non-invasive technique for stroke volume determination and performed before and after exposure to +Gz accelerations.

Conditions

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Atelectasis

Keywords

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human centrifuge, oxygen, imaging, stroke volume, lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ventilation

hypergravity gas mixture

Group Type EXPERIMENTAL

hypergravity

Intervention Type OTHER

1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)

gas mixture

Intervention Type OTHER

breathing air, 44.5%O2 or 100%O2

Interventions

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hypergravity

1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)

Intervention Type OTHER

gas mixture

breathing air, 44.5%O2 or 100%O2

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* normal lung function checked by pulmonary function tests

Exclusion Criteria

* past medical history of heart or lung disease
* current medical treatment for heart or lung disease
* smoking
* bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)


* past medical history of heart or lung disease
* current medical treatment for heart or lung disease
* smoking
* The use of medication for hypertension
* asymmetric values of left/right humeral arterial blood pressure
* significant echocardiographic abnormalities or bad echogenicity
* bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Val de Grâce Hospital

UNKNOWN

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Stéphanie Montmerle-Borgdorff

researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Garin, MD, PhD

Role: STUDY_CHAIR

Armed Forces Biomedical Research Institute

Locations

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Armed Forces Biomedical Research Institute

Brétigny-sur-Orge, , France

Site Status

Department of Nuclear Medicine, Val-de-Grâce hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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10co706

Identifier Type: -

Identifier Source: org_study_id