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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. (see Contacts and Locations)
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

January 31, 2013
January 31, 2013
April 2013
May 2015   (final data collection date for primary outcome measure)
least pulse oxymetry value [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Patients
  • Requiring Intubation
  • Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)
  • Patient Covered by French Health Care System
Procedure: - standard oxygenation
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
144
June 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01782430
CHU-0141, 2012-A00778-35
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
ICU, University Hospital Gabriel-Montpied, CHU Clermont-FD, France
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
January 2013

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