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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
Hopital Gabriel Montpied
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01782430
First received: January 31, 2013
Last updated: June 24, 2016
Last verified: June 2016

January 31, 2013
June 24, 2016
April 2015
September 2016   (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
Complete list of historical versions of study NCT01782430 on ClinicalTrials.gov Archive Site
  • 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.
 
Recruiting
132
September 2016
September 2016   (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   (Adult, Senior)
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01782430
CHU-0141, 2012-A00778-35
Not Provided
Not Provided
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Hopital Gabriel Montpied
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
June 2016

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