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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700321
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Need for Intubation, No Severe Hypoxemia Device: OPTIFLOW/ AIRVO Procedure: STANDARD Face Mask Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 28, 2016
Actual Primary Completion Date : June 27, 2017
Actual Study Completion Date : October 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pulse oximetry [ Time Frame: from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes ]
  2. 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) ]
  3. 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) ]
  4. SOFA score [ Time Frame: Each day during the 5 first days after randomisation ]


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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:

  • 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

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): NCT02700321


Locations
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France
Brest hospital, CHU La cavale Blanche, medical intensive care unit
Brest, France, 29609
CHD LES OUDOUAIRIES Service de réanimation polyvalente
La Roche Sur Yon, France, 85925
Ch Le Mans
Le Mans, France, 72033
Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit
Nantes, France, 44093
Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
Nantes, France, 44093
Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit
Rennes, France, 35033
Nantes University hospital, Hôpital Laennec, pneumology intensive care unit
St Herblain, France, 44800
Tours university hospital, hôpital Bretonneau, medical intensive care unit
Tours, France, 37044
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Olivier ZAMBON, MD Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02700321    
Other Study ID Numbers: RC15_0047
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nantes University Hospital:
non severely hypoxemic respiratory failure
preoxygenation
crash induction
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory