Effect of Hyperoxia and Hypergravity on Lung Ventilation... | NCT01993394

Studies
Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

NCT01993394

Sponsor

Direction Centrale du Service de Santé des Armées

Status

Completed

Last Update Posted

Nov 25, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Atelectasis

Interventions

hypergravity
gas mixture

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 14, 2013

First Submission Date that Met QC Criteria

Nov 20, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stéphanie Montmerle-Borgdorff, researcher, Direction Centrale du Service de Santé des ArméesPrincipal Investigator

Lead Sponsor

Direction Centrale du Service de Santé des ArméesOTHER

Collaborators

Name	Class
Val de Grâce Hospital	UNKNOWN
Uppsala University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ventilation	Experimental	hypergravity gas mixture	Other: hypergravity Other: gas mixture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hypergravity	Other	1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)	ventilation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in regional ventilation distribution	"per lobe and per quadrant at 5th intercostal space level"	baseline, 2hrs 30min

Secondary Outcomes

Measure	Description	Time Frame
change in regional pulmonary perfusion	"per lobe and per quadrant at 5th intercostal space level"	baseline, 2hrs 30min
cardiac output (L/min)	"echocardiography (sub-aortic diameter), photoplethysmography (Liljestrand, systolic area and Windkessel algorithms)"

Other Outcomes

Measure	Description	Time Frame
tidal volume	global (mL, area under the flow versus time curve) and regional (% change per quadrant at 5th intercostal space level)	2hrs 30min

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Garin, MD, PhD	Armed Forces Biomedical Research Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Armed Forces Biomedical Research Institute		Brétigny-sur-Orge		91 223	France
Department of Nuclear Medicine, Val-de-Grâce hospital

Condition Browse Module

MeSH Terms

ID	Term
D001261	Pulmonary Atelectasis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018471	Hypergravity
C041364	nitrox

Ancestor Terms

ID	Term
D018470	Gravity, Altered
D006112	Gravitation
D055580	Astronomical Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided