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Completed

NCT Number: NCT01993394

Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

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.

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Key information

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Armed Forces Biomedical Research Institute, Brétigny-sur-Orge, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

hypergravity

Other

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

gas mixture

Other

breathing air, 44.5%O2 or 100%O2

Primary outcomes

  1. change in regional ventilation distribution

    Time frame: baseline, 2hrs 30min

    "per lobe and per quadrant at 5th intercostal space level"

Secondary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Collaborators

  • Uppsala University Hospital
  • Val de Grâce Hospital

Registry information

Official study title

Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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