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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.
This study compares the effects of two devices for oxygen therapy, the nasal, high-flow (Optiflow, intervention) and the Venturi mask (control), on the outcome of extubation. Available data suggest that Optiflow can improve oxygenation and patient's comfort in critically ill patients after extubation. The study hypothesis is that Optiflow may reduce the extubation failure rate in these patients.
In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow oxygen through nasal cannula (Optiflow, Fisher & Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.
In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive oxygen through a standard Venturi mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). Further FiO2 modifications will be performed by the attending physicians to meet the oxygenation target.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal high-flow oxygen therapy | Experimental | High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher & Paykel Healthcare) after extubation up to ICU discharge |
|
| Venturi mask oxygen therapy | Active Comparator | Oxygen delivered through standard Venturi mask after extubation up to ICU discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflow (Fisher & Paykel Healthcare) | Device | This device delivers high-flow oxygen through nasal cannula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation | within 72 hours after extubation or at ICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Non-Invasive Ventilation | at day 28 after inclusion in the study or at ICU discharge | |
| ICU length of stay | at day 28 from the inclusion in the study or at ICU discharge | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Maurizio Maggiore, MD, PhD | Catholic University of the Sacred Heart, A. Gemelli Hospital, Rome, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sainte-Marguerite University Hospital | Marseille | France | ||||
| Lapeyronie University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25003980 | Background | Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC. | |
| 41188988 |
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| Venturi mask | Device | This device delivers low-flow oxygen at predetermined concentrations |
|
| Hospital length of stay |
| at day 28 from the inclusion in the study or at hospital discharge |
| ICU readmission | at day 28 from inclusion in the study |
| ICU mortality | at day 28 from inclusion in the study |
| Hospital mortality | at day 28 from inclusion in the study |
| Montpellier |
| France |
| Saint Eloi University Hospital | Montpellier | France |
| La Pitie-Salpetriere University Hospital | Paris | France |
| Louis Mourier University Hospital | Paris | France |
| Saint-Louis University Hospital | Paris | France |
| University Hospital | Poitiers | France |
| Evangelismos University Hospital | Athens | Greece |
| Policlinico University Hospital | Bari | Italy |
| Università del Piemonte Orientale, Ospedale della Carità | Novara | Italy |
| Catholic University of the Sacred Heart, A. Gemelli Hospital | Rome | 00168 | Italy |
| Le Molinette University Hospital | Turin | Italy |
| Università del Piemonte Orientale, Sant'Andrea Hospital | Vercelli | Italy |
| Sant Pau University Hospital | Barcelona | Spain |
| Grieco DL, Jaber S, Zakynthinos S, Demoule A, Ricard JD, Navalesi P, Vaschetto R, Hraiech S, Klouche K, Frat JP, Lemiale V, Fanelli V, Chanques G, Longhini F, Mancebo J, Gualano MR, Ferreyro BL, Brochard LJ, Antonelli M, Maggiore SM; RINO trial study group. Use of rescue noninvasive ventilation for post-extubation respiratory failure. Crit Care. 2025 Nov 4;29(1):470. doi: 10.1186/s13054-025-05689-w. |
| 35849787 | Derived | Maggiore SM, Jaber S, Grieco DL, Mancebo J, Zakynthinos S, Demoule A, Ricard JD, Navalesi P, Vaschetto R, Hraiech S, Klouche K, Frat JP, Lemiale V, Fanelli V, Chanques G, Natalini D, Ischaki E, Reuter D, Moran I, La Combe B, Longhini F, De Gaetano A, Ranieri VM, Brochard LJ, Antonelli M; RINO Trial Study Group. High-Flow Versus VenturiMask Oxygen Therapy to Prevent Reintubation in Hypoxemic Patients after Extubation: A Multicenter Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 15;206(12):1452-1462. doi: 10.1164/rccm.202201-0065OC. |
| 32205604 | Derived | Chaudhuri D, Granton D, Wang DX, Einav S, Helviz Y, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson C, Jaber S, Brochard L, Burns KEA, Rochwerg B. Moderate Certainty Evidence Suggests the Use of High-Flow Nasal Cannula Does Not Decrease Hypoxia When Compared With Conventional Oxygen Therapy in the Peri-Intubation Period: Results of a Systematic Review and Meta-Analysis. Crit Care Med. 2020 Apr;48(4):571-578. doi: 10.1097/CCM.0000000000004217. |