Effects of Expiratory Pressure on Arterial Oxygenation Du... | NCT01260428

Studies
Effects of Expiratory Pressure on Arterial Oxygenation During Hypoxia

NCT01260428

Sponsor

AGIR à Dom

Status

Unknown status

Last Update Posted

Feb 28, 2012Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Hypoxia

Interventions

threshold PEEP

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

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 14, 2010

First Posted Date

Dec 15, 2010Estimated

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

Feb 27, 2012

Last Update Posted Date

Feb 28, 2012Estimated

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

Altitude tolerance correlates with the level of oxygenation achieved. The aim of the present study is to investigate whether increased expiratory pressure within the thorax is able to improve oxygenation during hypoxic hypoxia.

Detailed Description

Two types of procedures will be tested in a random order, interspaced by resting periods : threshold PEEP set at 5,10 and 15 cm of water and pursed leap breathing.

Subjects will be tested at rest, and during light exercise (30% of sea level predicted VO2max).

FiO2 will be set at 12.5% (4000 m). fc, VE, PETCO2, TA, ECG, cardiac output, and tissular oxygenation will be monitored.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy active subjects		with and without high altitude intolerance	Device: threshold PEEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
threshold PEEP	Device	Various set of pressures : 0, 5, 10 cm H20; pursed lips breathing	healthy active subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SpO2	after three minutes of PEEP vs spontaneous breathing	mean over 1 minute

Secondary Outcomes

Measure	Description	Time Frame
peripheral HbO2/DeoxyHb	after three minutes of PEEP / PLB vs. spontaneous breathing	1 min
cardiac output	after three min of PEEP vs. spontaneous breathing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

active (> 2 hrs/week physical activity)
adult
non smoking volunteers

Exclusion Criteria :

cardiac, respiratory, neuromuscular, metabolic pathology

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

community sample with mounteneering experience

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bernard Wuyam, MD, PhD	Contact	33 (0)4 76 76 93 03		BWuyam@chu-grenoble.fr

Overall Officials

Name	Affiliation	Role
Bernard Wuyam, MD, PhD	University Hospital, Grenoble	Principal Investigator
Samuel Vergès, PhD	Institut National de la Santé Et de la Recherche Médicale, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Grenoble	Recruiting	La Tronche	Isere	38000	France

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided