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Completed

NCT Number: NCT02700321

Benefits of High Flow Nasal Cannula 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

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Key information

Conditions

Need for Intubation, No Severe Hypoxemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest hospital, CHU La cavale Blanche, medical intensive care unit, Brest, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPTIFLOW/ AIRVO

Device

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.

STANDARD Face Mask

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: PROTRACH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2016
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.