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

October 10, 2017 updated by: Poitiers University Hospital

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Brest, France
        • CHU La Cavale Blanche
      • Colombes, France
        • CHU Louis Mourier
      • Creteil, France
        • CHU Mondor
      • Dijon, France
        • CHU Dijon
      • La Roche/Yon, France
        • CH Vendée
      • La Rochelle, France
        • CH La Rochelle
      • Lille, France
        • CHU Lille
      • Limoges, France, 87042
        • Limoges university hospital
      • Lyon, France
        • Lyon Sud
      • Lyon, France
        • CH St Joseph St Luc
      • Lyon, France
        • Chu E. Herriot
      • Marseille, France
        • CHU Marseille
      • Montauban, France
        • CH
      • Montpellier, France
        • CHU Lapeyronie
      • Nice, France
        • Hopital de l'Archet
      • Orleans, France
        • CHU La Source
      • POINTE à PITRE, France
        • CHU Guadeloupe
      • Paris, France
        • CHU Tenon
      • Paris, France
        • CHU Cochin
      • Paris, France
        • CHU La Pitié Salpêtrière
      • Poitiers, France, 86000
        • CHU Poitiers
      • Poitiers, France, 86021
        • University Hospital of Poitiers
      • Rouen, France
        • Hôpital C. NICOLLE
      • Strasbourg, France
        • CHU Strasbourg
      • Suresnes, France
        • Hopital FOCH
      • Tours, France
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main inclusion Criteria:

  • acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

  • coma
  • NIV contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through five minutes after preoxygenation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLORALI 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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