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

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

Detailed Description
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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

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

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

Intervention / Treatment
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* Procedure: - standard oxygenation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard oxygenation<br>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<br> <br> |
| Experimental: High flow nasal oxygen therapy<br>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<br> <br> |
| Other: invasive ventilation (VNI)<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| least pulse oxymetry value |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoxygenation, Intubation