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
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 144
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782430

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

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
ICU, University Hospital Gabriel-Montpied, CHU Clermont-FD, France
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01782430     History of Changes
Other Study ID Numbers: CHU-0141, 2012-A00778-35
Study First Received: January 31, 2013
Last Updated: January 31, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on April 22, 2014