Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

Not Applicable

Completed

• Conditions: Atelectasis
• Interventions: Other: hypergravity; Other: gas mixture

• Registration Number: NCT01993394
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• normal lung function checked by pulmonary function tests

Part 1 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)

Part 2 exclusion criteria:

• 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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ventilation	hypergravity	hypergravity gas mixture
ventilation	gas mixture	hypergravity gas mixture

Primary Outcome Measures

Name	Time	Method
change in regional ventilation distribution	baseline, 2hrs 30min	"per lobe and per quadrant at 5th intercostal space level"

Secondary Outcome Measures

Name	Time	Method
cardiac output (L/min)	2hrs	"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"
change in regional pulmonary perfusion	baseline, 2hrs 30min	"per lobe and per quadrant at 5th intercostal space level"

Trial Locations

Locations (2)

Department of Nuclear Medicine, Val-de-Grâce hospital; 🇫🇷 Paris, France

Armed Forces Biomedical Research Institute; 🇫🇷 Brétigny-sur-Orge, France