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Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure (FLORALI2)

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ClinicalTrials.gov Identifier: NCT02668458
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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Brief Summary:

The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:

  1. NIV (Non Invasive Ventilation)
  2. HFNC (High-flow nasal canula oxygen therapy)

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Intratracheal Intubation Procedure: High Flow nasal canula oxygen therapy Procedure: Noninvasive ventilation Not Applicable

Detailed Description:

Design:

Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.

Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.

Randomized study, inclusion in two groups: NIV or HFNC.

Experimental group:

NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.

Control group:

NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.

Duration of participation of each patient: 28 days

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NIV
NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.
 Procedure: Noninvasive ventilation
Pre-oxygenation with non-invasive ventilation
Active Comparator: HFNC
High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
 Procedure: High Flow nasal canula oxygen therapy
Pre-oxygenation with high-flow nasal canula oxygen therapy


Outcome Measures
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Primary Outcome Measures :
  1. Severe desaturation as defined by a pulse oxymetry below 80% [ Time Frame: through five minutes after preoxygenation period ]
    drop below 80% of pulse oxymetry measurement


Eligibility Criteria
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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

Main inclusion Criteria:

  • acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

  • coma
  • NIV contraindication
Contacts and Locations
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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): NCT02668458


Locations
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Sponsors and Collaborators
Poitiers University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02668458    
Other Study ID Numbers: FLORALI 2
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases