Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
NCT ID: NCT02107183
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2014-06-30
2016-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Nasal high-flow oxygen therapy
High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher \& Paykel Healthcare) after extubation up to ICU discharge
Optiflow (Fisher & Paykel Healthcare)
This device delivers high-flow oxygen through nasal cannula
Venturi mask oxygen therapy
Oxygen delivered through standard Venturi mask after extubation up to ICU discharge
Venturi mask
This device delivers low-flow oxygen at predetermined concentrations
Interventions
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Optiflow (Fisher & Paykel Healthcare)
This device delivers high-flow oxygen through nasal cannula
Venturi mask
This device delivers low-flow oxygen at predetermined concentrations
Eligibility Criteria
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Inclusion Criteria
2. Mechanical ventilation \> 24 hours
3. Signed Informed Consent
4. Successful spontaneous breathing trial
5. PaO2/FiO2 ratio ≤ 300 (or SpO2/FiO2 ratio ≤ 300 if SpO2 is lower than 98%) within 30 min after extubation while breathing through a Venturi mask with a delivered FiO2 of 31%
Exclusion Criteria
2. Presence of tracheostomy
3. Need for immediate post-extubation Non-Invasive Ventilation (\>3 consecutive failures of the spontaneous breathing trial and/or a PaCO2 \> 45 mmHg before the spontaneous breathing trial, with a respiratory rate ≥ 25/min)
18 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Catholic University of the Sacred Heart
OTHER
Responsible Party
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Salvatore Maurizio MAGGIORE, MD, PhD
Associate Professor
Principal Investigators
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Salvatore Maurizio Maggiore, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of the Sacred Heart, A. Gemelli Hospital, Rome, Italy
Locations
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Sainte-Marguerite University Hospital
Marseille, , France
Lapeyronie University Hospital
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, , Italy
Le Molinette University Hospital
Turin, , Italy
Università del Piemonte Orientale, Sant'Andrea Hospital
Vercelli, , Italy
Sant Pau University Hospital
Barcelona, , Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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Trial120_A
Identifier Type: -
Identifier Source: org_study_id
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