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The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:
Design:
Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.
Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.
Randomized study, inclusion in two groups: NIV or HFNC.
Experimental group:
NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.
Control group:
NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.
Duration of participation of each patient: 28 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV | Experimental | NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%. |
|
| HFNC | Active Comparator | High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow nasal canula oxygen therapy | Procedure | Pre-oxygenation with high-flow nasal canula oxygen therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe desaturation as defined by a pulse oxymetry below 80% | drop below 80% of pulse oxymetry measurement | through five minutes after preoxygenation period |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU La cavale Blanche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34292408 | Derived | Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8. | |
| 30898520 |
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| Noninvasive ventilation | Procedure | Pre-oxygenation with non-invasive ventilation |
|
| Brest |
| France |
| CHU louis MOURIER | Colombes | France |
| Chu Mondor | Créteil | France |
| CHU Dijon | Dijon | France |
| CH Vendée | La Roche/Yon | France |
| CH La Rochelle | La Rochelle | France |
| CHU Lille | Lille | France |
| Limoges University Hospital | Limoges | 87042 | France |
| CH St Joseph St Luc | Lyon | France |
| Chu E. Herriot | Lyon | France |
| LYON Sud | Lyon | France |
| CHU marseille | Marseille | France |
| CH | Montauban | France |
| CHU Lapeyronie | Montpellier | France |
| Hopital de l'Archet | Nice | France |
| CHU La Source | Orléans | France |
| Chu Cochin | Paris | France |
| CHU La Pitié Salpétrière | Paris | France |
| Chu Tenon | Paris | France |
| CHU Guadeloupe | Pointe à Pitre | France |
| CHU Poitiers | Poitiers | 86000 | France |
| University Hospital of Poitiers | Poitiers | 86021 | France |
| Hôpital C. NICOLLE | Rouen | France |
| CHU Strasbourg | Strasbourg | France |
| Hôpital FOCH | Suresnes | France |
| Chu Tours | Tours | France |
| Derived |
| Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18. |
| 29275345 | Derived | Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611. |
| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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