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

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ClinicalTrials.gov Identifier: NCT02107183
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Salvatore Maurizio MAGGIORE, MD, PhD, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Weaning Failure Acute Respiratory Failure Device: Optiflow (Fisher & Paykel Healthcare) Device: Venturi mask Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
Study Start Date : June 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


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




Primary Outcome Measures :
  1. Reintubation [ Time Frame: within 72 hours after extubation or at ICU discharge ]

Secondary Outcome Measures :
  1. Need for Non-Invasive Ventilation [ Time Frame: at day 28 after inclusion in the study or at ICU discharge ]
  2. ICU length of stay [ Time Frame: at day 28 from the inclusion in the study or at ICU discharge ]
  3. Hospital length of stay [ Time Frame: at day 28 from the inclusion in the study or at hospital discharge ]
  4. ICU readmission [ Time Frame: at day 28 from inclusion in the study ]
  5. ICU mortality [ Time Frame: at day 28 from inclusion in the study ]
  6. Hospital mortality [ Time Frame: at day 28 from inclusion in the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107183


Locations
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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, France
Greece
Evangelismos University Hospital
Athens, Greece
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, 00168
Le Molinette University Hospital
Turin, Italy
Università del Piemonte Orientale, Sant'Andrea Hospital
Vercelli, Italy
Spain
Sant Pau University Hospital
Barcelona, Spain
Sponsors and Collaborators
Catholic University of the Sacred Heart
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Salvatore Maurizio Maggiore, MD, PhD Catholic University of the Sacred Heart, A. Gemelli Hospital, Rome, Italy

Publications:
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Responsible Party: Salvatore Maurizio MAGGIORE, MD, PhD, Associate Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02107183     History of Changes
Other Study ID Numbers: Trial120_A
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Salvatore Maurizio MAGGIORE, MD, PhD, Catholic University of the Sacred Heart:
Oxygen therapy
Extubation
Weaning
Reintubation
Acute respiratory failure

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases