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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT01782430

Collaborator

Hopital Gabriel Montpied (Other)

132

Enrollment

Location

Arms

17.1

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Apr 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

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
Other: 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

Arm

Intervention/Treatment

Experimental: Standard oxygenation

Procedure: - standard oxygenation

Experimental: High flow nasal oxygen therapy

Procedure: - standard oxygenation

Other: invasive ventilation (VNI)

Procedure: - standard oxygenation

Outcome Measures

Primary Outcome Measures

least pulse oxymetry value [at day 1]

Secondary Outcome Measures

pulse oxymetry value (at the end of preoxygenation) [at 5 minutes and at 30 minutes after intubation]
Partial pressure of arterial oxygen (PaO2) [at day 1]
Regurgitation rate [at day 1]
oxyhemoglobin desaturation below 80 % [at day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand
Hopital Gabriel Montpied

Investigators

Principal Investigator: Sébastien PERBET, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT01782430

Other Study ID Numbers:

CHU-0141
2012-A00778-35

First Posted:

Feb 1, 2013

Last Update Posted:

Jun 27, 2016

Last Verified:

Jun 1, 2016

Keywords provided by University Hospital, Clermont-Ferrand

Preoxygenation

Intubation

Additional relevant MeSH terms:

Hypoxia

Study Results

No Results Posted as of Jun 27, 2016