Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

Acute Respiratory Failure Clinical Trial

— RINO  

Official title:

Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107183
• Other study ID #: Trial120_A
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: July 18, 2017
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: July 2017
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Weaning Failure

Intervention

Device:
• Optiflow (Fisher & Paykel Healthcare)
This device delivers high-flow oxygen through nasal cannula
• Venturi mask
This device delivers low-flow oxygen at predetermined concentrations

Locations

Country	Name	City	State
France	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
Greece	Evangelismos University Hospital	Athens
Italy	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
Spain	Sant Pau University Hospital	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Fisher and Paykel Healthcare

Countries where clinical trial is conducted

France,  Greece,  Italy,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation		within 72 hours after extubation or at ICU discharge
Secondary	Need for Non-Invasive Ventilation		at day 28 after inclusion in the study or at ICU discharge
Secondary	ICU length of stay		at day 28 from the inclusion in the study or at ICU discharge
Secondary	Hospital length of stay		at day 28 from the inclusion in the study or at hospital discharge
Secondary	ICU readmission		at day 28 from inclusion in the study
Secondary	ICU mortality		at day 28 from inclusion in the study
Secondary	Hospital mortality		at day 28 from inclusion in the study