Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study (PREOXYFLOW)

December 9, 2013 updated by: Nantes University Hospital

A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure

Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event.

The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be designed as followed : Patients will be randomized in 2 groups :"PREOXYFLOW" or "STANDARD FACE MASK".

Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction

Study Type

Interventional

Enrollment (Actual)

122

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, 49933
        • Angers Universitary Hospital
      • Brest, France, 29609
        • Brest universitary hospital
      • La Roche/Yon, France, 85925
        • La Roche/Yon Hospital
      • Montpellier, France, 34295
        • Montpellier University Hospital
      • Nantes, France, 44093
        • Nantes Universitary Hospital, surgical intensive care unit
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44093
        • Nantes Universitary Hospital, medical intensive care unit

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

Inclusion Criteria:

  • Adults older than 18 years regardless of the gender
  • Acute hypoxemic respiratory failure defined as :

Respiratory rate > 30/mn AND Hypoxemia with SpO2 <90% with oxygen supply > FiO2 0,5 AND PaO2/FiO2 <300 mmHg

Exclusion Criteria:

  • Contraindication to oro-tracheal intubation
  • Intubation without anesthetic delivery
  • Intubation during cardiac arrest
  • Asphyxia with immediate intubation needed
  • Nasopharyngeal obstacle with contraindication to use Optiflow device
  • Patients with a documented Cormack IV exposition before inclusion
  • Protected adult
  • Pregnancy
  • Lack of consent
  • Patient already enrolled in an other randomized study.

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: PREOXYFLOW
Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction
Device: PREOXYFLOW
Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction
Active Comparator: STANDARD FACE MASK
Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. No specific trademark is requested by the protocol.
Procedure: STANDARD FACE MASK
Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.
Time Frame: 4 minutes
This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry
4 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of quality of preoxygenation
Time Frame: 4 minutes
4 minutes
Reduction in side effects incidence related to intubation
Time Frame: 1 hour
1 hour
Reduction in Organ failure in the 5th day
Time Frame: at day 5
at day 5
Reduction in morbi-mortality during the Intensive Care Unit stay.
Time Frame: until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU
until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU

Collaborators and Investigators

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

Sponsor

Nantes 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

November 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0178

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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