Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.

Study Overview
=================
Brief Summary
-----------------
This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.

Official Title
-----------------
Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study

Conditions
-----------------
ICU, Extubation, Non-invasive Ventilation, High-Flow Nasal Oxygen Therapy, Respiratory Effort, Work of Breathing, Tidal Volume

Intervention / Treatment
-----------------
* Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age: 18 years planned extubation decided by the physician in charge of the patient after success of weaning trial patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease Hypoxemia defined by PaO2/FiO2 < 300 mmHg under mechanical ventilation before extubation Exclusion Criteria: Duration of mechanical ventilation prior to extubation < 24h Contraindication to NIV Contraindication to nasogastric tube Do-not-reintubated order at time of extubation People under legal protection Opposition to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition) | Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen<br>* Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92%<br>|
| Other: Group 2<br>Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition) | Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen<br>* Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient respiratory effort and tidal volume (Vt) | Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography | 1h20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory parameters | respiratory rate (FR bt/min) | Time 0,Time 20 min, Time 40 min, Time 60 min, Time 120 min | 
| Respiratory parameters | saturation (SpO2 in %) | Time 0,Time 20 min, Time 40 min, Time 60 min, Time 120 min | 
| Respiratory parameters | transcutaneous CO2 pressure (PCO2 in mm Hg) | Time 0,Time 20 min, Time 40 min, Time 60 min, Time 120 min | 
| Respiratory parameters | transpulmonary pressure (cm H2O) | Time 0,Time 20 min, Time 40 min, Time 60 min, Time 120 min | 
| Hemodynamic parameters | Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg) | Time 0,Time 20 min, Time 40 min, Time 60 min, Time 120 min | 
| Comfort evaluation | comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort) | Time 0,Time 20 min, Time 40 min, Time 60 min, Time 120 min |