Preoxygenation for Difficult Airway Management

Nantes University Hospital186 enrolled

Overview

Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation

This study will be designed as followed: Patients will be randomized in 2 groups: * Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation. * Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

186

Conditions

Intubation;Difficult

Interventions

Preoxygenation with high flow therapy by nasal cannulaDEVICE

Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before fiber-optic or laryngoscopic intubation. The device will be maintained in place throughout the intubation procedure in order to achieve oxygenation.

Preoxygenation by standard Facial maskDEVICE

* For Fiber-optic intubation: patients will receive a 4 minutes FIBROXY facial mask preoxygenation with FiO2=100%. The FIBROXY facial mask will be maintained in place during the intubation procedure. * For Laryngoscopic intubation: patients will receive a 4 minutes standard facial mask preoxygenation with FiO2=100%. The standard facial mask will be removed after crash induction to proceed to intubation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of aged and over * And anticipated difficult intubation * And requiring a rapid sequence induction for laryngoscopic intubation * Or requiring a fiberoptic intubation Exclusion Criteria: * BMI \> 35 * Pulse oxymetry \< 90% in ambient air * Haemodynamic instability * Pregnancy * Protected adult * Lack of consent * Patient already enrolled in another randomized study looking forward improving preoxygenation quality.

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.

To determine whether High-Flow nasal cannula used for preoxygenation and oxygenation during intubation, is more efficient than standard care during difficult intubation. This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry.

Time frame: 4 minutes

Secondary Outcomes

Improvement of quality of preoxygenation

duration of proceedings

Time frame: 4 minutes

Reduction in side effects incidence related to intubation

Time frame: 6 hours

Morbi-mortality during surgery.

Per and postoperative complication rate

Time frame: 6 hours

Data from ClinicalTrials.gov

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