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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with severe life threatening complications. To decrease these complications, preoxygenation is recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation, applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC) improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has never been evaluated. The aim of this study is to determine if HFNC combined to NIV could have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated for hypoxemic acute respiratory failure.

Condition or disease Intervention/treatment Phase
Intubation Intraesophageal Device: Non invasive ventilation + High flow nasal cannula oxygen Device: Non invasive ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Interventional
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.

Reference
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.




Primary Outcome Measures :
  1. Lowest oxygen saturation [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Number of complications related to intubation [ Time Frame: 1 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult hypoxemic patients
  • Patients intubated in the ICU for acute respiratory failure (Hypoxemia is defined by the need of a FiO2>50% to maintain a SpO2>90% and a PaO2/FiO2 ratio<300 mmHg under mask oxygen therapy with a flow of 15L/min (measured during the 4 hours before inclusion)).

Exclusion Criteria:

  • non adult patients (age <18 years)
  • pregnant woman
  • protected persons
  • Patient intubated in case of cardio circulatory arrest
  • Patient with nasopharyngeal obstacle contraindicating the use of HNFC

Information from the National Library of Medicine

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


Locations
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France
Centre Hospitalier Universitaire Montpellier, Saint Eloi
Montpellier, Languedoc-Roussillon, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Samir JABER, M.D, Ph.D Departement of Unit Care in Montpellier
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02530957    
Other Study ID Numbers: 9543
2015-A00708-41 ( Other Identifier: RCB number )
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Keywords provided by University Hospital, Montpellier:
Intubation
Preoxygenation
Complications
Non invasive ventilation
High flow nasal cannula