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

This study is not yet open for participant recruitment.

Verified January 2013 by University Hospital, Clermont-Ferrand

Sponsor:

Collaborator:

ICU, University Hospital Gabriel-Montpied, CHU Clermont-FD, France

Information provided by (Responsible Party):

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT01782430

First received: January 31, 2013

Last updated: NA

Last verified: January 2013

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 31, 2013

Last Updated Date

January 31, 2013

Start Date ^ICMJE

April 2013

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

least pulse oxymetry value [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

pulse oxymetry value (at the end of preoxygenation) [ Time Frame: at 5 minutes and at 30 minutes after intubation ] [ Designated as safety issue: No ]
Partial pressure of arterial oxygen (PaO2) [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
Regurgitation rate [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
oxyhemoglobin desaturation below 80 % [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: - standard oxygenation

Study Arm (s)

Experimental: 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

Intervention: Procedure: - standard oxygenation
Experimental: 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

Intervention: Procedure: - standard oxygenation
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

Intervention: Procedure: - standard oxygenation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

144

Estimated Completion Date

June 2015

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Patrick LACARIN

04 73 75 11 95

placarin@chu-clermontferrand.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01782430

Other Study ID Numbers ^ICMJE

CHU-0141, 2012-A00778-35

Has Data Monitoring Committee

Not Provided

Responsible Party

University Hospital, Clermont-Ferrand

Study Sponsor ^ICMJE

University Hospital, Clermont-Ferrand

Collaborators ^ICMJE

ICU, University Hospital Gabriel-Montpied, CHU Clermont-FD, France

Investigators ^ICMJE

Principal Investigator:

Sébastien PERBET

University Hospital, Clermont-Ferrand

Information Provided By

University Hospital, Clermont-Ferrand

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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