Evaluating High-flow Nasal Cannula Oxygen Therapy Through LUS During Weaning

Study Overview
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Brief Summary
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Respiratory distress after extubation is associated with increased morbidity and mortality. Its multifactorial pathophysiology causes a loss of pulmonary aeration during the weaning process, the clinical translation being impaired gas exchange and the occurrence of respiratory distress. Lung ultrasound can accurately quantify the loss of pulmonary aeration before, after end during the weaning trial by calculating the Lung Ultrasound Score (LUS). Investigators have recently demonstrated in a prospective two-center study of 100 patients that the intensity of the lung aeration loss occurring during the weaning trial, was predictive of the development of postextubation respiratory distress within 48 hours following extubation. A LUS ≥ 14 could identify patients at high risk of developing postextubation respiratory distress. A second study that investigators have just completed in 80 patients weaned from mechanical ventilation shows a 30% reduction of respiratory distress in post-extubation High Flow Nasal Cannula oxygen group compared to a standard O2 group. The establishment of a targeted therapeutic strategy proposed in a group of high-risk patients, defined as having a ≥ 14 LUS at the end of the weaning trial could reduce the incidence of extubation failure and associated morbidity and mortality.

Official Title
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Evaluating High-flow Nasal Cannula Oxygen Therapy Through Lung Ultrasound Score

Conditions
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High-flow Nasal Cannula Oxygen

Intervention / Treatment
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* Device: high-flow nasal cannula oxygen
* Device: Conventional oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients above 18, mechanically ventilated on tracheal intubation for more than 48 hours. Exclusion Criteria: Patients with chronic obstructive pulmonary disease (COPD) with moderate to severe (3 and 4) stage defined by a forced expiratory volume in one second (FEV) <50% of theoretical value Patients with previous chronic respiratory disease Paraplegia with level> T8, Severe ICU-acquired neuromyopathy Patients with tracheostomy for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional oxygen therapy<br>oxygen by a standard nasal cannula or nonrebreather mask | Device: Conventional oxygen therapy<br>* oxygen by a standard nasal cannula or nonrebreather mask<br>|
| Active Comparator: High-flow Nasal Cannula Oxygen Therapy<br>High-flow Nasal Cannula Oxygen Therapy | Device: high-flow nasal cannula oxygen<br>* high-flow nasal cannula oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients. | To decrease the incidence of extubation failure within 48 hours after a successful spontaneous breathing trial in ICU patients. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilation-free days in ICU following the planned extubation after randomization. - Length of stay in ICU and in-hospital after randomization. - Mortality in ICU and at three months. | Number of ventilation-free days and mortality in ICU and at three months. | treatment in ICU and at three months. |