Non Invasive Ventilation Combined to High Flow Nasal Cannula Oxygen for Preoxygenation of Hypoxemic ICU Patients (OPTINIV)
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|ClinicalTrials.gov Identifier: NCT02530957|
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intubation Intraesophageal||Device: Non invasive ventilation + High flow nasal cannula oxygen Device: Non invasive ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Methods of Preoxygenation Before Oro Tracheal Intubation in the Hypoxemic Patient in Intensive Care Unit : Non Invasive Ventilation (NIV) + High Flow Nasal Cannula Oxygen Versus NIV Alone : a Randomized Controlled Study|
|Actual Study Start Date :||June 23, 2015|
|Actual Primary Completion Date :||February 28, 2016|
|Actual Study Completion Date :||March 17, 2016|
In the interventional group, a preoxygenation by NIV (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) combined to HNFC (Flow of 60L/min, FiO2 = 100%) is applied.
Device: Non invasive ventilation + High flow nasal cannula oxygen
In the interventional group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% and combined to HNFC (nasal cannula oxygen of Fisher and Paykel) with Flow of 60L/min, FiO2 = 100% is applied.
In the reference group, a preoxygenation by NIV only (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) is applied.
Device: Non invasive ventilation
In the reference group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) only, with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% is applied.
- Lowest oxygen saturation [ Time Frame: 1 years ]
- Number of complications related to intubation [ Time Frame: 1 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530957
|Centre Hospitalier Universitaire Montpellier, Saint Eloi|
|Montpellier, Languedoc-Roussillon, France, 34295|
|Principal Investigator:||Samir JABER, M.D, Ph.D||Departement of Unit Care in Montpellier|