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

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3; Phase 2

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

Treatments: Procedure: - standard oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT01782430

2012-A00778-35 (Registry Identifier)

CHU-0141

Details and patient eligibility

About

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

Full 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

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Standard oxygenation

Experimental group

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

Treatment:

Procedure: - standard oxygenation

High flow nasal oxygen therapy

Experimental group

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

Treatment:

Procedure: - standard oxygenation

invasive ventilation (VNI)

Other group

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

Treatment:

Procedure: - standard oxygenation