Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
Primary Purpose
Atelectasis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypergravity
gas mixture
Sponsored by
About this trial
This is an interventional basic science trial for Atelectasis focused on measuring human centrifuge, oxygen, imaging, stroke volume, lung
Eligibility 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)
Sites / Locations
- Armed Forces Biomedical Research Institute
- Department of Nuclear Medicine, Val-de-Grâce hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ventilation
Arm Description
hypergravity gas mixture
Outcomes
Primary Outcome Measures
change in regional ventilation distribution
"per lobe and per quadrant at 5th intercostal space level"
Secondary Outcome Measures
change in regional pulmonary perfusion
"per lobe and per quadrant at 5th intercostal space level"
cardiac output (L/min)
"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"
Full Information
NCT ID
NCT01993394
First Posted
November 14, 2013
Last Updated
November 20, 2013
Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Val de Grâce Hospital, Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01993394
Brief Title
Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
Official Title
Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Val de Grâce Hospital, Uppsala University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
human centrifuge, oxygen, imaging, stroke volume, lung
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ventilation
Arm Type
Experimental
Arm Description
hypergravity gas mixture
Intervention Type
Other
Intervention Name(s)
hypergravity
Intervention Description
1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
Intervention Type
Other
Intervention Name(s)
gas mixture
Intervention Description
breathing air, 44.5%O2 or 100%O2
Primary Outcome Measure Information:
Title
change in regional ventilation distribution
Description
"per lobe and per quadrant at 5th intercostal space level"
Time Frame
baseline, 2hrs 30min
Secondary Outcome Measure Information:
Title
change in regional pulmonary perfusion
Description
"per lobe and per quadrant at 5th intercostal space level"
Time Frame
baseline, 2hrs 30min
Title
cardiac output (L/min)
Description
"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"
Time Frame
2hrs
Other Pre-specified Outcome Measures:
Title
tidal volume
Description
global (mL, area under the flow versus time curve) and regional (% change per quadrant at 5th intercostal space level)
Time Frame
2hrs 30min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Garin, MD, PhD
Organizational Affiliation
Armed Forces Biomedical Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Armed Forces Biomedical Research Institute
City
Brétigny-sur-Orge
ZIP/Postal Code
91 223
Country
France
Facility Name
Department of Nuclear Medicine, Val-de-Grâce hospital
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
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Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
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