Clinical trial NCT02107183: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
Official title: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning Failure
Acute Respiratory Failure
Keywords: Oxygen therapy
Extubation
Weaning
Reintubation
Acute respiratory failure
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2014-04-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
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:

1. Pregnancy
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)

Primary outcomes:
measure: Reintubation
timeFrame: within 72 hours after extubation or at ICU discharge
Secondary outcomes:
measure: Need for Non-Invasive Ventilation
timeFrame: at day 28 after inclusion in the study or at ICU discharge
measure: ICU length of stay
timeFrame: at day 28 from the inclusion in the study or at ICU discharge
measure: Hospital length of stay
timeFrame: at day 28 from the inclusion in the study or at hospital discharge
measure: ICU readmission
timeFrame: at day 28 from inclusion in the study
measure: ICU mortality
timeFrame: at day 28 from inclusion in the study
measure: Hospital mortality
timeFrame: at day 28 from inclusion in the study
Other outcomes:
Locations:
city: Marseille
country: France
facility: Sainte-Marguerite University Hospital
city: Montpellier
country: France
facility: Lapeyronie University Hospital
city: Montpellier
country: France
facility: Saint Eloi University Hospital
city: Paris
country: France
facility: La Pitie-Salpetriere University Hospital
city: Paris
country: France
facility: Louis Mourier University Hospital
city: Paris
country: France
facility: Saint-Louis University Hospital
city: Poitiers
country: France
facility: University Hospital
city: Athens
country: Greece
facility: Evangelismos University Hospital
city: Bari
country: Italy
facility: Policlinico University Hospital
city: Novara
country: Italy
facility: Università del Piemonte Orientale, Ospedale della Carità
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart, A. Gemelli Hospital
city: Turin
country: Italy
facility: Le Molinette University Hospital
city: Vercelli
country: Italy
facility: Università del Piemonte Orientale, Sant'Andrea Hospital
city: Barcelona
country: Spain
facility: Sant Pau University Hospital
Study officials:
affiliation: Catholic University of the Sacred Heart, A. Gemelli Hospital, Rome, Italy
name: Salvatore Maurizio Maggiore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.