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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01993394
Other study ID # 10co706
Secondary ID
Status Completed
Phase N/A
First received November 14, 2013
Last updated November 20, 2013
Start date October 2011
Est. completion date July 2012

Study information

Verified date November 2013
Source Direction Centrale du Service de Santé des Armées
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 45 Years
Eligibility 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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
hypergravity
1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
gas mixture
breathing air, 44.5%O2 or 100%O2

Locations

Country Name City State
France Armed Forces Biomedical Research Institute Brétigny-sur-Orge
France Department of Nuclear Medicine, Val-de-Grâce hospital Paris

Sponsors (3)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées Uppsala University Hospital, Val de Grâce Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other tidal volume global (mL, area under the flow versus time curve) and regional (% change per quadrant at 5th intercostal space level) 2hrs 30min Yes
Primary change in regional ventilation distribution "per lobe and per quadrant at 5th intercostal space level" baseline, 2hrs 30min Yes
Secondary change in regional pulmonary perfusion "per lobe and per quadrant at 5th intercostal space level" baseline, 2hrs 30min Yes
Secondary cardiac output (L/min) "echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)" 2hrs Yes
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