Intubation;Difficult
Conditions
Keywords
Preoxygenation, High flow nasal cannula
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.
Interventions
DEVICEPreoxygenation with high flow therapy by nasal cannula
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.
DEVICEPreoxygenation by standard Facial mask
* 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.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMickael VOURC'H, PH
Nantes University Hospital
Outcome results
None listed