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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-04-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Failure Requiring Reintubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HFNC alone

Control group

Group Type ACTIVE_COMPARATOR

HFNC

Intervention Type DEVICE

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

HFNC and NIV

Group Type EXPERIMENTAL

HFNC

Intervention Type DEVICE

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

NIV

Intervention Type DEVICE

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%

Interventions

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HFNC

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

Intervention Type DEVICE

NIV

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%

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No