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

Phase 2

• Conditions: Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200); Adult Patients; Requiring Intubation; Patient Covered by French Health Care System
• Interventions: Procedure: - standard oxygenation

• Registration Number: NCT01782430
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Study Start: 2015-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-24
• Last Update Posted: 2016-06-27
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard oxygenation	- 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
invasive ventilation (VNI)	- 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
High flow nasal oxygen therapy	- 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

Primary Outcome Measures

Name	Time	Method
least pulse oxymetry value	at day 1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France