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Weaning FailureRINONCT02107183

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

A study testing Optiflow (Fisher & Paykel Healthcare) and Venturi mask in people with Weaning Failure and Acute Respiratory Failure, run by Catholic University of the Sacred Heart at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weaning Failure, Acute Respiratory Failure
What is being tested?
Optiflow (Fisher & Paykel Healthcare) and Venturi mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
14 sitesin 4 countries
Study dates
Jun 2014to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Mechanical ventilation > 24 hours
  • Signed Informed Consent
  • Successful spontaneous breathing trial
  • 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%

Who cannot join

  • Pregnancy
  • Presence of tracheostomy
  • 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)

Trial locations and contacts

14 sites in 4 countries.

14 sites in 4 countries

France7 sites

  • Sainte-Marguerite University Hospital

    Marseille

  • Lapeyronie University Hospital

    Montpellier

  • Saint Eloi University Hospital

    Montpellier

  • La Pitie-Salpetriere University Hospital

    Paris

  • Louis Mourier University Hospital

    Paris

  • Saint-Louis University Hospital

    Paris

  • University Hospital

    Poitiers

Other trials in France

Italy5 sites

  • Policlinico University Hospital

    Bari

  • Università del Piemonte Orientale, Ospedale della Carità

    Novara

  • Catholic University of the Sacred Heart, A. Gemelli Hospital

    Rome, 00168

  • Le Molinette University Hospital

    Turin

  • Università del Piemonte Orientale, Sant'Andrea Hospital

    Vercelli

Other trials in Italy

Greece1 site

  • Evangelismos University Hospital

    Athens

Other trials in Greece

Spain1 site

  • Sant Pau University Hospital

    Barcelona

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Optiflow (Fisher & Paykel Healthcare), Venturi mask
Keywords
Oxygen therapy, Extubation, Weaning, Reintubation, Acute respiratory failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optiflow (Fisher & Paykel Healthcare)Device

    This device delivers high-flow oxygen through nasal cannula

  • Venturi maskDevice

    This device delivers low-flow oxygen at predetermined concentrations

Study groups in NCT02107183
Study groupRoleWhat they receive
Nasal high-flow oxygen therapyExperimentalHigh-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher \& Paykel Healthcare) after extubation up to ICU discharge
Receives: Device: Optiflow (Fisher & Paykel Healthcare)
Venturi mask oxygen therapyActive comparatorOxygen delivered through standard Venturi mask after extubation up to ICU discharge
Receives: Device: Venturi mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reintubation

    Measured: within 72 hours after extubation or at ICU discharge

Secondary outcomes (6)

  1. Need for Non-Invasive Ventilation

    Measured: at day 28 after inclusion in the study or at ICU discharge

  2. ICU length of stay

    Measured: at day 28 from the inclusion in the study or at ICU discharge

  3. Hospital length of stay

    Measured: at day 28 from the inclusion in the study or at hospital discharge

  4. ICU readmission

    Measured: at day 28 from inclusion in the study

  5. ICU mortality

    Measured: at day 28 from inclusion in the study

  6. Hospital mortality

    Measured: at day 28 from inclusion in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107183
Sponsor's protocol ID
Trial120_A
Acronym
RINO
Status last verified
Jul 2017
First submitted
4 Apr 2014
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 25003980

  • 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.

    PubMed 41188988

  • 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.

    PubMed 35849787

  • 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.

    PubMed 32205604

Questions about this trial

What is this clinical trial studying?

A study testing Optiflow (Fisher & Paykel Healthcare) and Venturi mask in people with Weaning Failure and Acute Respiratory Failure, run by Catholic University of the Sacred Heart at 14 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France, Italy, Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reintubation (time frame: within 72 hours after extubation or at ICU discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107183, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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