Clinical Trials Directory

Trials / Completed

CompletedNCT01993394

Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Direction Centrale du Service de Santé des Armées · Academic / Other
Sex
Male
Age
25 Years – 45 Years
Healthy volunteers
Accepted

Summary

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

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

Interventions

TypeNameDescription
OTHERhypergravity1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
OTHERgas mixturebreathing air, 44.5%O2 or 100%O2

Timeline

Start date
2011-10-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2013-11-25
Last updated
2013-11-25

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01993394. Inclusion in this directory is not an endorsement.