PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intubation;Difficult
- Sponsor
- Nantes University Hospital
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of desaturation below 95% or manual facial mask reventilation during ETI procedure.
Time Frame: 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 Outcomes
- Improvement of quality of preoxygenation(4 minutes)
- Reduction in side effects incidence related to intubation(6 hours)
- Morbi-mortality during surgery.(6 hours)