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Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

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ClinicalTrials.gov Identifier: NCT01993394
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Collaborators:
Val de Grâce Hospital
Uppsala University Hospital
Information provided by (Responsible Party):
Stéphanie Montmerle-Borgdorff, 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.

Condition or disease Intervention/treatment Phase
Atelectasis Other: hypergravity Other: gas mixture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion
Study Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: ventilation
hypergravity gas mixture
Other: hypergravity
1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)

Other: gas mixture
breathing air, 44.5%O2 or 100%O2




Primary Outcome Measures :
  1. change in regional ventilation distribution [ Time Frame: baseline, 2hrs 30min ]
    "per lobe and per quadrant at 5th intercostal space level"


Secondary Outcome Measures :
  1. change in regional pulmonary perfusion [ Time Frame: baseline, 2hrs 30min ]
    "per lobe and per quadrant at 5th intercostal space level"

  2. cardiac output (L/min) [ Time Frame: 2hrs ]
    "echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"


Other Outcome Measures:
  1. tidal volume [ Time Frame: 2hrs 30min ]
    global (mL, area under the flow versus time curve) and regional (% change per quadrant at 5th intercostal space level)



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993394


Locations
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France
Armed Forces Biomedical Research Institute
Brétigny-sur-Orge, France, 91 223
Department of Nuclear Medicine, Val-de-Grâce hospital
Paris, France, 75005
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Val de Grâce Hospital
Uppsala University Hospital
Investigators
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Study Chair: Daniel Garin, MD, PhD Armed Forces Biomedical Research Institute
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Responsible Party: Stéphanie Montmerle-Borgdorff, researcher, Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT01993394    
Other Study ID Numbers: 10co706
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Stéphanie Montmerle-Borgdorff, Direction Centrale du Service de Santé des Armées:
human centrifuge, oxygen, imaging, stroke volume, lung
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Hyperoxia
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory