Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoxygenation with high flow therapy by nasal cannula | Experimental | High flow oxygen therapy by nasal cannula. |
|
| Preoxygenation by standard Facial mask | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoxygenation with high flow therapy by nasal cannula | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of quality of preoxygenation | duration of proceedings | 4 minutes |
| Reduction in side effects incidence related to intubation | 6 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mickael VOURC'H, PH | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37251624 | Derived | Vourc'h M, Huard D, Le Penndu M, Deransy R, Surbled M, Malidin M, Mahe PJ, Guitton C, Roquilly A, Malard O, Feuillet F, Rozec B, Asehnoune K. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998. doi: 10.1016/j.eclinm.2023.101998. eCollection 2023 Jun. | |
| 31028041 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Preoxygenation by standard Facial mask | Device |
|
|
| Morbi-mortality during surgery. | Per and postoperative complication rate | 6 hours |
| Derived |
| Vourc'h M, Huard D, Feuillet F, Baud G, Guichoux A, Surbled M, Tissot M, Chiffoleau A, Guitton C, Jaber S, Asehnoune K. Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study. BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909. |