AtelectasisNCT01993394
Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion
A study testing hypergravity and gas mixture in people with Atelectasis, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- hypergravity and gas mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Armed Forces Biomedical Research Institute
Brétigny-sur-Orge, 91 223
Department of Nuclear Medicine, Val-de-Grâce hospital
Paris, 75005
About this study
Official title: Influence of Hyperoxia and Hypergravity on Pulmonary 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.
Read the 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.
- Conditions
- Atelectasis
- Being tested
- hypergravity, gas mixture
- Keywords
- human centrifuge, oxygen, imaging, stroke volume, lung
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypergravityOther
1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
gas mixtureOther
breathing air, 44.5%O2 or 100%O2
| Study group | Role | What they receive |
|---|---|---|
| ventilation | Experimental | hypergravity gas mixture Receives: Other: hypergravity; Other: gas mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in regional ventilation distribution
"per lobe and per quadrant at 5th intercostal space level"
Measured: baseline, 2hrs 30min
Secondary outcomes (2)
change in regional pulmonary perfusion
"per lobe and per quadrant at 5th intercostal space level"
Measured: baseline, 2hrs 30min
cardiac output (L/min)
"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"
Measured: 2hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Val de Grâce Hospital, Uppsala University Hospital
- Responsible party
- Principal investigator, Stéphanie Montmerle-Borgdorff, Direction Centrale du Service de Santé des Armées
- Investigators
- Daniel Garin, MD, PhD, Study chair, Armed Forces Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993394
- Sponsor's protocol ID
- 10co706
- Status last verified
- Nov 2013
- First submitted
- 14 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hyperoxia and Hypergravity on Pulmonary Ventilation and Perfusion
- ClinicalTrials.gov ID
- NCT01993394
- Acronym / sponsor ID
- 10co706
- Conditions
- Atelectasis
- Keywords
- human centrifuge, oxygen, imaging, stroke volume, lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Val de Grâce Hospital, Uppsala University Hospital
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilation | Experimental | Other: hypergravity, Other: gas mixturehypergravity gas mixture |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- normal lung function checked by pulmonary function tests
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypergravity1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs) | Other | ventilation |
| gas mixturebreathing air, 44.5%O2 or 100%O2 | Other | ventilation |
Primary outcome
change in regional ventilation distribution
Time frame: baseline, 2hrs 30min
"per lobe and per quadrant at 5th intercostal space level"
2 secondary outcomes
change in regional pulmonary perfusion
Time frame: baseline, 2hrs 30min
cardiac output (L/min)
Time frame: 2hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
Related trials for Atelectasis
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Garin, MD, PhD study chair
Armed Forces Biomedical Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypergravity and gas mixture in people with Atelectasis, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in regional ventilation distribution (time frame: baseline, 2hrs 30min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.