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

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.

Study Overview

• Status: Completed
• Conditions: Weaning Failure; Acute Respiratory Failure
• Intervention / Treatment: Device: Optiflow (Fisher & Paykel Healthcare); Device: Venturi mask

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Sainte-Marguerite University Hospital
  • Montpellier, France
    • Lapeyronie University Hospital
  • Montpellier, France
    • Saint Eloi University Hospital
  • Paris, France
    • La Pitie-Salpetriere University Hospital
  • Paris, France
    • Louis Mourier University Hospital
  • Paris, France
    • Saint-Louis University Hospital
  • Poitiers, France
    • University Hospital
• Greece
  • Athens, Greece
    • Evangelismos University Hospital
• Italy
  • Bari, Italy
    • Policlinico University Hospital
  • Novara, Italy
    • Università del Piemonte Orientale, Ospedale della Carità
  • Rome, Italy, 00168
    • Catholic University of the Sacred Heart, A. Gemelli Hospital
  • Turin, Italy
    • Le Molinette University Hospital
  • Vercelli, Italy
    • Università del Piemonte Orientale, Sant'Andrea Hospital
• Spain
  • Barcelona, Spain
    • Sant Pau University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal high-flow oxygen therapy; High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher & Paykel Healthcare) after extubation up to ICU discharge	Device: Optiflow (Fisher & Paykel Healthcare); This device delivers high-flow oxygen through nasal cannula
Active Comparator: Venturi mask oxygen therapy; Oxygen delivered through standard Venturi mask after extubation up to ICU discharge	Device: Venturi mask; This device delivers low-flow oxygen at predetermined concentrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reintubation	within 72 hours after extubation or at ICU discharge

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Salvatore Maurizio Maggiore, MD, PhD, Catholic University of the Sacred Heart, A. Gemelli Hospital, Rome, Italy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Weaning; Oxygen therapy; Extubation; Acute respiratory failure; Reintubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Trial120_A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No