Preoxygenation for Difficult Airway Management

Not Applicable

Completed

• Conditions: Intubation;Difficult
• Interventions: Device: Preoxygenation by standard Facial mask; Device: Preoxygenation with high flow therapy by nasal cannula

• Registration Number: NCT03604120
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2018-06-22
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2018-09-19
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoxygenation by standard Facial mask	Preoxygenation by standard Facial mask	Patients randomized in "STANDARD FACIAL MASK" group will receive a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction or Fiber-optic intubation under spontaneous ventilation.
Preoxygenation with high flow therapy by nasal cannula	Preoxygenation with high flow therapy by nasal cannula	High flow oxygen therapy by nasal cannula.

Primary Outcome Measures

Name	Time	Method
Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.	4 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Improvement of quality of preoxygenation	4 minutes	duration of proceedings
Reduction in side effects incidence related to intubation	6 hours
Morbi-mortality during surgery.	6 hours	Per and postoperative complication rate

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France