Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
| Percy Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100%O2 breathing | Experimental | Primary aim, item 1 |
|
| Air breathing | Experimental | Primary aim, item 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| +Gz accelerations and positive pressure breathing | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| atelectasis formation (change between pre and post-protocol) | computerized tomography: 0-5 scale for size and localization | 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 | 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 | pre protocol (baseline), at centrifuge stop (baseline + 1h15 min) and 1h30 min after centrifuge stop |
Not provided
Not provided
Inclusion Criteria:
Aim 1 exclusion criteria:
Aim 2 exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie S Montmerle-Borgdorff, MD, PhD | Contact | +33(1)78651249 | stephanie.montmerle@intradef.gouv.fr | |
| Catherine Verret, MD, PhD | Contact | +33(1)78651115 | catherine.verret@intradef.gouv.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dominique Felten, MD | Armed Forces Biomedical Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armed Forces Biomedical Research Institute | Recruiting | Brétigny-sur-Orge | 91 223 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27103651 | Background | 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. | |
| 25323531 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007385 | Intermittent Positive-Pressure Ventilation |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Department of Radiology, Percy hospital | Active, not recruiting | Clamart | 92140 | France |
| Borges 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. |
| D012138 |
| Respiratory Therapy |