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

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ClinicalTrials.gov Identifier: NCT01782430
Recruitment Status : Recruiting
First Posted : February 1, 2013
Last Update Posted : June 27, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Condition or disease Intervention/treatment Phase
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 Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
Study Start Date : April 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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
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
Procedure: - standard oxygenation


Outcome Measures

Primary Outcome Measures :
  1. least pulse oxymetry value [ Time Frame: at day 1 ]

Secondary Outcome Measures :
  1. pulse oxymetry value (at the end of preoxygenation) [ Time Frame: at 5 minutes and at 30 minutes after intubation ]
  2. Partial pressure of arterial oxygen (PaO2) [ Time Frame: at day 1 ]
  3. Regurgitation rate [ Time Frame: at day 1 ]
  4. oxyhemoglobin desaturation below 80 % [ Time Frame: at day 1 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782430


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Hopital Gabriel Montpied
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01782430     History of Changes
Other Study ID Numbers: CHU-0141
2012-A00778-35 ( Registry Identifier: 2012-A00778-35 )
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Preoxygenation
Intubation

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms