NCT02107183

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

April 4, 2014

Last Update Submit

July 18, 2017

Conditions

Weaning FailureAcute Respiratory Failure

Keywords

Oxygen therapyExtubationWeaningReintubationAcute respiratory failure

Outcome Measures

Primary Outcomes (1)

  • Reintubation

    within 72 hours after extubation or at ICU discharge

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Nasal high-flow oxygen therapy

EXPERIMENTAL

High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher \& Paykel Healthcare) after extubation up to ICU discharge

Device: Optiflow (Fisher & Paykel Healthcare)

Venturi mask oxygen therapy

ACTIVE COMPARATOR

Oxygen delivered through standard Venturi mask after extubation up to ICU discharge

Device: Venturi mask

Interventions

Optiflow (Fisher & Paykel Healthcare)DEVICE

This device delivers high-flow oxygen through nasal cannula

Nasal high-flow oxygen therapy
Venturi maskDEVICE

This device delivers low-flow oxygen at predetermined concentrations

Venturi mask oxygen therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Sainte-Marguerite University Hospital

Marseille, France

Location

Lapeyronie University Hospital

Montpellier, France

Location

Saint Eloi University Hospital

Montpellier, France

Location

La Pitie-Salpetriere University Hospital

Paris, France

Location

Louis Mourier University Hospital

Paris, France

Location

Saint-Louis University Hospital

Paris, France

Location

University Hospital

Poitiers, France

Location

Evangelismos University Hospital

Athens, Greece

Location

Policlinico University Hospital

Bari, Italy

Location

Università del Piemonte Orientale, Ospedale della Carità

Novara, Italy

Location

Catholic University of the Sacred Heart, A. Gemelli Hospital

Rome, 00168, Italy

Location

Le Molinette University Hospital

Turin, Italy

Location

Università del Piemonte Orientale, Sant'Andrea Hospital

Vercelli, Italy

Location

Sant Pau University Hospital

Barcelona, Spain

Location

Related Publications (4)

  • 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.

    PMID: 25003980BACKGROUND

  • 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.

    PMID: 41188988DERIVED

  • 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.

    PMID: 35849787DERIVED

  • 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.

    PMID: 32205604DERIVED

Study Officials

  • Salvatore Maurizio Maggiore, MD, PhD

    Catholic University of the Sacred Heart, A. Gemelli Hospital, Rome, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)ES(1)FR(7)IT(5)