NCT01993394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

November 14, 2013

Last Update Submit

November 20, 2013

Conditions

Atelectasis

Keywords

human centrifuge, oxygen, imaging, stroke volume, lung

Outcome Measures

Primary Outcomes (1)

  • change in regional ventilation distribution

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

    baseline, 2hrs 30min

Secondary Outcomes (2)

  • change in regional pulmonary perfusion

    baseline, 2hrs 30min

  • cardiac output (L/min)

    2hrs

Other Outcomes (1)

  • tidal volume

    2hrs 30min

Study Arms (1)

ventilation

EXPERIMENTAL

hypergravity gas mixture

Other: hypergravityOther: gas mixture

Interventions

hypergravityOTHER

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

ventilation
gas mixtureOTHER

breathing air, 44.5%O2 or 100%O2

ventilation

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal lung function checked by pulmonary function tests

You may not qualify if:

  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Armed Forces Biomedical Research Institute

Brétigny-sur-Orge, 91 223, France

Location

Department of Nuclear Medicine, Val-de-Grâce hospital

Paris, 75005, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Hypergravitynitrox

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Gravity, AlteredGravitationAstronomical PhenomenaPhysical Phenomena

Study Officials

  • Daniel Garin, MD, PhD

    Armed Forces Biomedical Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 25, 2013

Study Start

October 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

FR(2)