search
Back to results

Atelectasis Formation: Role of Positive Pressure Breathing, Hyperoxia, and Hypobaria

Primary Purpose

Pulmonary Atelectasis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
+Gz accelerations and positive pressure breathing
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pulmonary Atelectasis focused on measuring pulmonary ultrasound, hypergravity, human physiology, oxygen, lung ventilation, lung perfusion, computed tomography, electrical impedance tomography, altitude chamber

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • normal lung function checked by pulmonary function tests.
  • normal ECG
  • normal clinical examination

Aim 1 exclusion criteria:

  • smoking
  • myopia
  • 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

Sites / Locations

  • Armed Forces Biomedical Research InstituteRecruiting
  • Department of Radiology, Percy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

100%O2 breathing

Air breathing

Arm Description

Primary aim, item 1

Primary aim, item 1

Outcomes

Primary Outcome Measures

atelectasis formation (change between pre and post-protocol)
computerized tomography: 0-5 scale for size and localization
change in pulmonary ventilation between 1 Gz, 1.6 Gz and 3.5 Gz
electrical impedance tomography: deltaZ on regions of interest
change in pulmonary tissue density from baseline at centrifuge stop and 1h30 min after stop
ultrasound: number of lung comets + localization

Secondary Outcome Measures

Full Information

First Posted
April 5, 2017
Last Updated
May 13, 2019
Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Uppsala University Hospital, Percy Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03311347
Brief Title
Atelectasis Formation: Role of Positive Pressure Breathing, Hyperoxia, and Hypobaria
Official Title
Influence of Hyperoxia and Hypobaria on Atelectasis Occurrence and Mitigation of Atelectasis Formation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2015 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Uppsala University Hospital, Percy Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
pulmonary ultrasound, hypergravity, human physiology, oxygen, lung ventilation, lung perfusion, computed tomography, electrical impedance tomography, altitude chamber

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
100%O2 breathing
Arm Type
Experimental
Arm Description
Primary aim, item 1
Arm Title
Air breathing
Arm Type
Experimental
Arm Description
Primary aim, item 1
Intervention Type
Other
Intervention Name(s)
+Gz accelerations and positive pressure breathing
Primary Outcome Measure Information:
Title
atelectasis formation (change between pre and post-protocol)
Description
computerized tomography: 0-5 scale for size and localization
Time Frame
pre-protocol (baseline) and 1h30 min after centrifuge stop
Title
change in pulmonary ventilation between 1 Gz, 1.6 Gz and 3.5 Gz
Description
electrical impedance tomography: deltaZ on regions of interest
Time Frame
pre-protocol (baseline), baseline + 1hr, baseline +1h10 min, baseline +1h15 min
Title
change in pulmonary tissue density from baseline at centrifuge stop and 1h30 min after stop
Description
ultrasound: number of lung comets + localization
Time Frame
pre protocol (baseline), at centrifuge stop (baseline + 1h15 min) and 1h30 min after centrifuge stop

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. normal ECG normal clinical examination Aim 1 exclusion criteria: smoking myopia 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie S Montmerle-Borgdorff, MD, PhD
Phone
+33(1)78651249
Email
stephanie.montmerle@intradef.gouv.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Verret, MD, PhD
Phone
+33(1)78651115
Email
catherine.verret@intradef.gouv.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Felten, MD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie S Montmerle-Borgdorff, MD, PhD
Phone
+33(1)78651249
Email
stephanie.montmerle@intradef.gouv.fr
First Name & Middle Initial & Last Name & Degree
Maquilon-Lefebvre David, nurse
Phone
+33(1)78651091
Email
david.maquilon@intradef.gouv.fr
First Name & Middle Initial & Last Name & Degree
Stephanie S Montmerle-Borgdorff, MD, PhD
First Name & Middle Initial & Last Name & Degree
Göran Hedenstierna, Pr, MD, PhD
First Name & Middle Initial & Last Name & Degree
João Batista Borges, MD, PhD
First Name & Middle Initial & Last Name & Degree
Caroline Dussault, PhD
Facility Name
Department of Radiology, Percy hospital
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27103651
Citation
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.
Results Reference
background
PubMed Identifier
25323531
Citation
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.
Results Reference
result

Learn more about this trial

Atelectasis Formation: Role of Positive Pressure Breathing, Hyperoxia, and Hypobaria

We'll reach out to this number within 24 hrs