High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

Poitiers University Hospital650 enrolled

Overview

Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

650

Conditions

Acute Respiratory Failure Requiring Reintubation

Interventions

HFNCDEVICE

Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%

NIVDEVICE

Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Duration of mechanical ventilation prior to extubation at least 24h * Planned extubation decided by the physician in charge of the patient after success of a weaning trial * Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease. Exclusion Criteria: * Patient admitted for traumatic brain injury * Periphal neuromuscular disease as reason for intubation * Usual lon-term treatment with NIV for chronic desease * Usual lon-term treatment with CPAP for obstructive apneas syndrome * Contraindication to NIV * Unplanned extubation * Do-not-reintubated order at time of extubation * Terminal extubation for end of life * People under legal protection * Opposition to participate

Locations (1)

CHU Poitiers

Poitiers, France

Outcomes

Primary Outcomes

Reintubation at Day 7

The rate of reintubation will be assessed within the 7 days following planned extubation

Time frame: up to 7 days

Data from ClinicalTrials.gov

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