Intubation;Difficult Clinical Trial
— PREOPTI-DAMOfficial title:
PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial
Verified date | May 2021 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 186 |
Est. completion date | March 8, 2021 |
Est. primary completion date | March 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 minutes | |
Secondary | Improvement of quality of preoxygenation | duration of proceedings | 4 minutes | |
Secondary | Reduction in side effects incidence related to intubation | 6 hours | ||
Secondary | Morbi-mortality during surgery. | Per and postoperative complication rate | 6 hours |
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