PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

NCT ID: NCT01782430

Last Updated: 2016-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-09-30

Brief Summary

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Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Detailed Description

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Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Conditions

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Adult Patients Requiring Intubation Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200) Patient Covered by French Health Care System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard oxygenation

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Group Type EXPERIMENTAL

- standard oxygenation

Intervention Type PROCEDURE

High flow nasal oxygen therapy

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Group Type EXPERIMENTAL

- standard oxygenation

Intervention Type PROCEDURE

invasive ventilation (VNI)

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Group Type OTHER

- standard oxygenation

Intervention Type PROCEDURE

Interventions

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- standard oxygenation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adults patients
* requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
* patient covered by french health care system

Exclusion Criteria

* patient refusal
* intubation for other causes (excluding hypoxemia)
* impossibility to measure pulse oxymetry value
* contraindication for NIV : vomiting
* NIV intolerance
* cardiac arrest during intubation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Gabriel Montpied

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sébastien PERBET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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2012-A00778-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHU-0141

Identifier Type: -

Identifier Source: org_study_id

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