Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units
VENTILO
2 other identifiers
interventional
670
5 countries
47
Brief Summary
In intensive care units (ICUs), around 20% of patients experience respiratory failure after planned extubation. Nearly 40-50% of them eventually require reintubation with subsequently high mortality rates reaching 30-40%. NIV used as rescue therapy to treat post-extubation respiratory failure could increase the risk of death. However, NIV may avoid reintubation in a number of cases, and recent large-scale clinical trials on extubation have shown that around 40 to 50% of patients with post-extubation respiratory failure are actually treated with NIV. Whereas high-flow nasal oxygen has never been specifically studied for management of post-extubation respiratory failure, this respiratory support could also in this setting constitute an alternative to standard oxygen or NIV. Given the best noninvasive respiratory support strategy in patients with post-extubation respiratory failure remains unknown, we have decided to assess whether NIV alternating with high-flow nasal oxygen as compared to high-flow nasal oxygen alone may decrease mortality of patients in ICUs with post-extubation respiratory failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 27, 2028
May 26, 2026
January 1, 2026
5.1 years
January 6, 2023
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality at 28 days after post-extubation respiratory failure
Death between post-extubation respiratory failure and 28 days after post-extubation respiratory failure
Day 28
Secondary Outcomes (5)
Time to death between randomization and day 28
Day 28
Reintubation within the 48 hours, 7 days and 28 days following post-extubation respiratory failure
Hour 48 Day 7 and Day 28
Ventilator-free days at day 28,
Day 28
Length of stay in ICU and length of stay in hospital.
Day 90
Mortality in ICU, in hospital and at day 90.
Day 90
Study Arms (2)
High-Flow Oxygen
ACTIVE COMPARATORPatients assigned to the control group will be continuously treated by high-flow nasal oxygen during the 48 hours following randomization
NIV alternating with High-Flow Oxygen
EXPERIMENTALPatients assigned to the intervention group will be treated with curative NIV alternating with high-flow nasal oxygen during the 48 hours following randomization
Interventions
Humidified and heated oxygen with a gas flow at least 50 L/min through nasal cannula
NIV will be carried out in pressure-support mode with a minimal pressure-support level of 5 cmH2O targeting a tidal volume around 6 to 8 mL/kg of predicted bodyweight, a positive end-expiratory pressure (PEEP) level at least 8 cm H2O, and FiO2 adjusted to obtain adequate oxygenation
Eligibility Criteria
You may qualify if:
- Duration of invasive mechanical ventilation of more than 24h in the ICU before extubation.
- Post-extubation respiratory failure occurring within the first 7 days after extubation (see criteria below). As in several previous studies, post-extubation respiratory failure will be defined by the presence of the 2 following criteria combining a clinical criterion and a blood gas criterion:
- Clinical criterion persisting for at least 30 minutes: a respiratory rate exceeding 25 breaths per minute or clinical signs of respiratory distress with increased accessory muscle activity.
- Blood gas criterion: Hypoxemia defined as PaO2/FiO2 ratio below 150 mm Hg or respiratory acidosis defined as pH below 7.35 units and PaCO2 above 45 mm Hg. For patients under standard oxygen, FiO2 will calculated according to the following formula: FiO2 = 0.21 + 0.03 x (oxygen flow L/min).
You may not qualify if:
- NIV at home
- ICU admission for peripheral neuromuscular disease type Guillain-Barré syndrome or myasthenia gravis.
- Upper airway obstruction as main reason for post-extubation respiratory failure
- Urgent need for reintubation (respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, or severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support)
- Altered consciousness (Glasgow coma scale \< 12)
- Unplanned extubation (accidental or self-extubation)
- Do-not-reintubate order at time of respiratory failure
- Patient previously included in the study
- People under protection (minors, persons deprived of liberty by a judicial or administrative decision, adults under law protection)
- Patient not affiliated to health care system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Erasme Hospital
Brussels, Belgium
Angers University Hospital
Angers, France
Victor Dupouy Hospital
Argenteuil, France
Henri Mondor Hospital
Aurillac, France
Henri Duffaut Hospital
Avignon, France
Nord-Franche-Comté Hospital
Belfort, France
Bordeaux University Hospital
Bordeaux, France
Fleyriat Hospital
Bourg-en-Bresse, France
Brest University Hospital
Brest, France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Louis Mourier Hospital
Colombes, France
Cèdres Clinic
Cornebarrieu, France
Henri Mondor Hospital
Créteil, France
Dax Hospital
Dax, France
Francois Mitterrand Hospital
Dijon, France
Grenoble University Hospital
Grenoble, France
Vendée Hospital
La Roche-sur-Yon, France
La Rochelle Hospital
La Rochelle, France
André Mignot Hospital
Le Chesnay, France
Le Mans Hospital
Le Mans, France
Lens Hospital
Lens, France
Lille University Hospital
Lille, France
Limoges University Hospital
Limoges, France
Saint Joseph Saint Luc Hospital
Lyon, France
La Timone Hospital
Marseille, France
Mont de Marsan Hospital
Mont-de-Marsan, France
Moulins-Yzeure Hospital
Moulins, France
Emile Muller Hospital
Mulhouse, France
Nantes University Hospital
Nantes, France
Nice University Hospital
Nice, France
Orléans University Hospital
Orléans, France
La Pitié Salpêtrière Hospital
Paris, France
Pau Hospital
Pau, France
Poitiers University Hospital
Poitiers, France
Rennes University Hospital
Rennes, France
Rouen University Hospital
Rouen, France
Saint Nazaire Hospital
Saint-Nazaire, France
Saintes Hospital
Saintes, France
Foch Hospital
Suresnes, France
Tours University Hospital
Tours, France
Vannes Hospital
Vannes, France
Pierre Zobda Quitman Hospital
Fort-de-France, Martinique
Felix Guyon Hospital
Saint-Denis, Reunion
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Complejo Hospitalario Universitario de Toledo
Toledo, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud W. THILLE, PhD
CHU Poitiers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2023
First Posted
January 17, 2023
Study Start
February 2, 2023
Primary Completion (Estimated)
February 27, 2028
Study Completion (Estimated)
August 27, 2028
Last Updated
May 26, 2026
Record last verified: 2026-01