Pulmonary AtelectasisNCT03311347
Atelectasis Formation: Role of Positive Pressure Breathing, Hyperoxia, and Hypobaria
A study testing +Gz accelerations and positive pressure breathing in people with Pulmonary 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 of the physiology of flight atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +Gz-accelerations. 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
- Pulmonary Atelectasis
- What is being tested?
- +Gz accelerations and positive pressure breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Sep 2015to 1 Jan 2020
- 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.
- normal ECG
- normal clinical examination
- Aim 1 exclusion criteria:
- smoking
- myopia
Show all 18Show fewer
- past medical history of heart or lung disease
- current medical treatment for heart or lung disease
- past medical history of back pain or spine trauma or disease
- otitis
- bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
- claustrophobia in the centrifuge gondola
- Aim 2 exclusion criteria:
- smoking
- past medical history of heart or lung disease
- current medical treatment for heart or lung disease
- otitis
- bad tolerance to the altitude chamber (15,000 ft): ear pain, claustrophobia
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Recruiting
Armed Forces Biomedical Research Institute
Brétigny-sur-Orge, 91 223
Stephanie S Montmerle-Borgdorff, MD, PhD, +33(1)78651249, stephanie.montmerle@intradef.gouv.fr
Maquilon-Lefebvre David, nurse, +33(1)78651091, david.maquilon@intradef.gouv.fr
- Active, not recruiting
Department of Radiology, Percy hospital
Clamart, 92140
About this study
Official title: Influence of Hyperoxia and Hypobaria on Atelectasis Occurrence and Mitigation of Atelectasis Formation
The primary aim of this project is to get further knowledge of the physiology of flight atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +Gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional ventilation and perfusion.
A secondary aim is to evaluate the effect of anti G-trouser inflation on ventilation and regional perfusion.
Read the detailed description
The effect of positive pressure breathing on lung function is being studied, when applied during exposure to hyperoxia and +Gz-accelerations. Focus is on lung tissue compression, ventilation and regional perfusion. In addition, the influence of hypobaria on these parameters is assessed.
This study is conducted in accordance with the amended Declaration of Helsinki. The Ethics Committee Ile-de-France III (ref. 3274) and the French National Agency for Drug Safety ANSM have approved the protocol (ref. ID RCB 2015-A00485-44 and ANSM 151046B-32).
Primary aim, item 1: Experiments are conducted in a human centrifuge. The protocol mimics a routine peacetime flight in combat aircraft, and includes 1hr05 min at +1Gz followed by 10-min exposure to +1.4 to +3.5Gz . Subjects are exposed three times to this sequence, breathing at positive pressure levels of 0, 5 or 10 hPa. Two groups of sixteen healthy male non-smoking volunteers, wearing anti-G trousers, are studied and compared: group 1 breathes air, group 2 100% O2.
Primary aim, item 2: Experiments are conducted in a hypobaric chamber. Sixteen healthy male non-smoking volunteers are exposed to four conditions: 0 or 15,000 ft altitude, breathing air or 100%O2. Protocol duration is 1h15min. Positive breathing pressure can be applied depending on the results of the experiments of item 1.
Secondary aim: Experiments are conducted in a human centrifuge. Sixteen healthy male non-smoking volunteers are exposed to four conditions: uninflated or inflated anti-G trousers (175 hPa), +1 or +3.5 Gz for 3 min.
- Conditions
- Pulmonary Atelectasis
- Being tested
- +Gz accelerations and positive pressure breathing
- Keywords
- pulmonary ultrasound, hypergravity, human physiology, oxygen, lung ventilation, lung perfusion, computed tomography, electrical impedance tomography, altitude chamber
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+Gz accelerations and positive pressure breathingOther
| Study group | Role | What they receive |
|---|---|---|
| 100%O2 breathing | Experimental | Primary aim, item 1 Receives: Other: +Gz accelerations and positive pressure breathing |
| Air breathing | Experimental | Primary aim, item 1 Receives: Other: +Gz accelerations and positive pressure breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
atelectasis formation (change between pre and post-protocol)
computerized tomography: 0-5 scale for size and localization
Measured: pre-protocol (baseline) and 1h30 min after centrifuge stop
change in pulmonary ventilation between 1 Gz, 1.6 Gz and 3.5 Gz
electrical impedance tomography: deltaZ on regions of interest
Measured: pre-protocol (baseline), baseline + 1hr, baseline +1h10 min, baseline +1h15 min
change in pulmonary tissue density from baseline at centrifuge stop and 1h30 min after stop
ultrasound: number of lung comets + localization
Measured: pre protocol (baseline), at centrifuge stop (baseline + 1h15 min) and 1h30 min after centrifuge stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start14 Sep 2015
- Primary completion30 Jun 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two arms are studied, breathing air or 100%O2. In each arm, subjects are studied at two occasions: with and without positive pressure breathing. These occasions are randomized.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Percy Hospital
- Responsible party
- Sponsor
- Investigators
- Dominique Felten, MD, Study chair, Armed Forces Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311347
- Sponsor's protocol ID
- PDH1-SMO2-0714
- Status last verified
- May 2019
- First submitted
- 5 Apr 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dussault C, Gontier E, Verret C, Soret M, Boussuges A, Hedenstierna G, Montmerle-Borgdorff S. Hyperoxia and hypergravity are independent risk factors of atelectasis in healthy sitting humans: a pulmonary ultrasound and SPECT/CT study. J Appl Physiol (1985). 2016 Jul 1;121(1):66-77. doi: 10.1152/japplphysiol.00085.2016. Epub 2016 Apr 21.
PubMed 27103651Borges JB, Hedenstierna G, Bergman JS, Amato MB, Avenel J, Montmerle-Borgdorff S. First-time imaging of effects of inspired oxygen concentration on regional lung volumes and breathing pattern during hypergravity. Eur J Appl Physiol. 2015 Feb;115(2):353-63. doi: 10.1007/s00421-014-3020-9. Epub 2014 Oct 17.
PubMed 25323531
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hyperoxia and Hypobaria on Atelectasis Occurrence and Mitigation of Atelectasis Formation
- ClinicalTrials.gov ID
- NCT03311347
- Acronym / sponsor ID
- PDH1-SMO2-0714
- Conditions
- Pulmonary Atelectasis
- Keywords
- pulmonary ultrasound, hypergravity, human physiology, oxygen, lung ventilation, lung perfusion, computed tomography, electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Percy Hospital
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 17 Oct 2017 (actual)
- 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 of the physiology of flight atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +Gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional ventilation and perfusion.
A secondary aim is to evaluate the effect of anti G-trouser inflation on ventilation and regional perfusion.
Detailed description
The effect of positive pressure breathing on lung function is being studied, when applied during exposure to hyperoxia and +Gz-accelerations. Focus is on lung tissue compression, ventilation and regional perfusion. In addition, the influence of hypobaria on these parameters is assessed.
This study is conducted in accordance with the amended Declaration of Helsinki. The Ethics Committee Ile-de-France III (ref. 3274) and the French National Agency for Drug Safety ANSM have approved the protocol (ref. ID RCB 2015-A00485-44 and ANSM 151046B-32).
Primary aim, item 1: Experiments are conducted in a human centrifuge. The protocol mimics a routine peacetime flight in combat aircraft, and includes 1hr05 min at +1Gz followed by 10-min exposure to +1.4 to +3.5Gz . Subjects are exposed three times to this sequence, breathing at positive pressure levels of 0, 5 or 10 hPa. Two groups of sixteen healthy male non-smoking volunteers, wearing anti-G trousers, are studied and compared: group 1 breathes air, group 2 100% O2.
Primary aim, item 2: Experiments are conducted in a hypobaric chamber. Sixteen healthy male non-smoking volunteers are exposed to four conditions: 0 or 15,000 ft altitude, breathing air or 100%O2. Protocol duration is 1h15min. Positive breathing pressure can be applied depending on the results of the experiments of item 1.
Secondary aim: Experiments are conducted in a human centrifuge. Sixteen healthy male non-smoking volunteers are exposed to four conditions: uninflated or inflated anti-G trousers (175 hPa), +1 or +3.5 Gz for 3 min.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms are studied, breathing air or 100%O2. In each arm, subjects are studied at two occasions: with and without positive pressure breathing. These occasions are randomized.
| Arm | Type | Receives |
|---|---|---|
| 100%O2 breathing | Experimental | Other: +Gz accelerations and positive pressure breathingPrimary aim, item 1 |
| Air breathing | Experimental | Other: +Gz accelerations and positive pressure breathingPrimary aim, item 1 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- normal lung function checked by pulmonary function tests.
- normal ECG
- normal clinical examination
- smoking
- myopia
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 |
|---|---|---|
| +Gz accelerations and positive pressure breathing | Other | 100%O2 breathing, Air breathing |
Primary outcome
atelectasis formation (change between pre and post-protocol)
Time frame: pre-protocol (baseline) and 1h30 min after centrifuge stop
computerized tomography: 0-5 scale for size and localization
change in pulmonary ventilation between 1 Gz, 1.6 Gz and 3.5 Gz
Time frame: pre-protocol (baseline), baseline + 1hr, baseline +1h10 min, baseline +1h15 min
electrical impedance tomography: deltaZ on regions of interest
change in pulmonary tissue density from baseline at centrifuge stop and 1h30 min after stop
Time frame: pre protocol (baseline), at centrifuge stop (baseline + 1h15 min) and 1h30 min after centrifuge stop
ultrasound: number of lung comets + localization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Background: PubMed 27103651Dussault C, Gontier E, Verret C, Soret M, Boussuges A, Hedenstierna G, Montmerle-Borgdorff S. Hyperoxia and hypergravity are independent risk factors of atelectasis in healthy sitting humans: a pulmonary ultrasound and SPECT/CT study. J Appl Physiol (1985). 2016 Jul 1;121(1):66-77. doi: 10.1152/japplphysiol.00085.2016. Epub 2016 Apr 21.
- Results publication: PubMed 25323531Borges JB, Hedenstierna G, Bergman JS, Amato MB, Avenel J, Montmerle-Borgdorff S. First-time imaging of effects of inspired oxygen concentration on regional lung volumes and breathing pattern during hypergravity. Eur J Appl Physiol. 2015 Feb;115(2):353-63. doi: 10.1007/s00421-014-3020-9. Epub 2014 Oct 17.
- Individual participant dataSharing planned: No
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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.
Dominique Felten, MD 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 +Gz accelerations and positive pressure breathing in people with Pulmonary 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 18 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: status not confirmed, as of the sponsor's last update on 14 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie S Montmerle-Borgdorff, MD, PhD (+33(1)78651249, stephanie.montmerle@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atelectasis formation (change between pre and post-protocol) (time frame: pre-protocol (baseline) and 1h30 min after centrifuge stop). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311347, which also lists 2 linked publications.
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 14 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.