Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients (PROTRACH)

March 1, 2019 updated by: Nantes University Hospital

A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be designed as followed : patients will be randomized in 2 groups : High Flow nasal cannula "HFNC" or standard High Flow face mask "HFFM".

Patients randomized in "HFNC" group will receive a four minutes preoxygenation period with Nasal High Flow Therapy (60 L/mn , fraction of inspired oxygen (FI02) = 100%) before orotracheal intubation under laryngoscopy after crash induction. After induction and during laryngoscopy, HFNC will be maintained in an attempt to achieve apneic oxygenation.

Patients randomized in "HFFM" group will received a four minutes preoxygenation period with standard face mask (15 L/mn) before orotracheal intubation under laryngoscopy after crash induction. After induction, HFFM will be removed, enabling laryngoscopic vision

Study Type

Interventional

Enrollment (Actual)

192

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
      • Brest, France, 29609
        • Brest hospital, CHU La cavale Blanche, medical intensive care unit
      • La Roche Sur Yon, France, 85925
        • CHD LES OUDOUAIRIES Service de réanimation polyvalente
      • Le Mans, France, 72033
        • CH Le mans
      • Nantes, France, 44093
        • Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit
      • Nantes, France, 44093
        • Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
      • Rennes, France, 35033
        • Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit
      • St Herblain, France, 44800
        • Nantes University hospital, Hôpital Laennec, pneumology intensive care unit
      • Tours, France, 37044
        • Tours university hospital, hôpital Bretonneau, 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
  • Requiring orotracheal intubation in intensive care unit
  • "No severely hypoxemic respiratory failure" defined as Oxygen Pression (Pa02)/FI02 > 200 mmHg measured in the 4 hours before inclusion

Exclusion Criteria:

  • Not the first Intubation during this stay in intensive care unit
  • Contraindication to oro-tracheal intubation
  • Intubation without anaesthesic rapid sequence induction
  • Intubation during cardiac arrest
  • Real emergency (as asphyxia) with immediate intubation needed (without time enough for randomization)
  • Nasopharyngeal obstacle with contraindication to use Optiflow device
  • Patients with a documented Cormack IV exposition before inclusion
  • Protected adult
  • Pregnancy or breastfeeding
  • Lack of consent
  • Patient already enrolled in another study that could interfere with the primary objective of this 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: High Flow nasal cannula oxygen (HFNC)
Patients randomized in "HFNC" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/Airvo® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.
Device: OPTIFLOW/ AIRVO
Patients randomized in "HFNC" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/AIRVO® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.
Active Comparator: STANDARD high flow Face Mask (HFFM)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lowest pulse oxymetry (SpO2) during intubation
Time Frame: From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes
This outcome will be assessed from the beginning of the endotracheal intubation procedure (immediately after induction) to the end of orotracheal intubation (airway catheterization) by monitoring the pulse oxymetry
From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulse oximetry
Time Frame: from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
number of desaturation events (under 80%)
Time Frame: From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)
From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)
Reduction in morbi-mortality during the Intensive care Unit stay
Time Frame: from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
SOFA score
Time Frame: Each day during the 5 first days after randomisation
Each day during the 5 first days after randomisation

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Olivier ZAMBON, MD, 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 (Actual)

April 28, 2016

Primary Completion (Actual)

June 27, 2017

Study Completion (Actual)

October 5, 2017

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC15_0047

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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