High Flow Oxygen VERSUS Non Invasive Ventilation Associated to Automated Flow Oxygen Titration After Patient Extubation

Study Overview
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Brief Summary
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Extubation stay at high risk of reintubation even scheduled and in the best condition of hematosis. Re-intubation's rate in main studies in chronic obstructive diseases reach to 20% and it is associated to a higher mortality, higher pneumonia under mechanic ventilation, and higher duration of hospitalization especially in intensive care units. Place of NIV in this situation is still on evaluation. A recent meta-analysis demonstrates that use of NIV in post-extubation in COPD seems to decrease re-intubation rate. HFO, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, HFO seems to be as efficient and better tolerated. A recent study shows that HFO is non-inferior to NVI in post-extubation in patient with high risk of re-intubation. Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation. Place of AFOT could improve hematosis by providing adapted flow of oxygen to each patient. The investigator choose the hypothesis for this study that HFO is as effective and tolerated in post-extubation than NIV with AFOT.

Detailed Description
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A recent meta-analysis demonstrates that use of NIV in post-extubation in obstructive chronic bronchopathies seems to decrease re-intubation rate. High Flow Oxygen, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, High Flow Oxygen seems to be as efficient and better tolerated . A recent study shows that High Flow Oxygen is non-inferior to Non Invasive Ventilation in post-extubation in patient with high risk of re-intubation. Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation.

Official Title
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High Flow Oxygen (HFO) VERSUS Non Invasive Ventilation (NIV) Associated to Automated Flow Oxygen Titration (AFOT) After Extubation in Patient With Respiratory Risk: Non-inferiority Prospective Comparative Study

Conditions
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Respiratory Disease

Intervention / Treatment
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* Device: High Flow Oxygen (HFO)
* Device: Non Invasive Ventilation (NIV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with respiratory disease suspected or proved (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial pneumonia, obstructive insufficient respiratory, restrictive insufficient respiratory) when an extubation is scheduled. Patient who signed the informed consent Patient affiliated to social insurance Exclusion Criteria: Pregnant woman Terminal extubation NIV at home before intubation (non-exclusion of continue positive airway pressure: CPAP) Tracheotomy Patient under trusteeship, guardianship or safeguard of justice

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 |
| --- | --- |
| Experimental: High Flow Oxygen (HFO)<br>HFO is a mix tap of air and oxygen. It permits to control FiO2 and generated controlled high flow air until 60/min. Air and oxygen are mixed, warmed, humidified and issued to patient by a warming monopod inspiratory circuit to nasal cannulas of a large diameter. Expiration is free. | Device: High Flow Oxygen (HFO)<br>* HFO is a mix tap of air and oxygen. It permits to control FiO2 and generated controlled high flow air until 60/min. Air and oxygen are mixed, warmed, humidified and issued to patient by a warming monopod inspiratory circuit to nasal cannulas of a large diameter. Expiration is free.<br>|
| Active Comparator: Non Invasive Ventilation (NIV)<br>NIV was already evaluated in post-extubation. This technic is now used in daily consolidation processing after extubation because it provides a ventilator help with two levels of pressure helping in respiratory work. Adding Automated Flow Oxygen Titration could optimized patient's oxygenation and reduce workload of caregivers | Device: Non Invasive Ventilation (NIV)<br>* NIV was already evaluated in post-extubation. This technic is now used in daily consolidation processing after extubation because it provides a ventilator help with two levels of pressure helping in respiratory work. Adding Automated Flow Oxygen Titration could optimized patient's oxygenation and reduce workload of caregivers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: Tolerance of each dispositive | Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable) | Hours 0 | 
| Primary outcome: Tolerance of each dispositive | Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable) | Hours 6 | 
| Primary outcome: Tolerance of each dispositive | Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable) | Hours 24 | 
| Primary outcome: Tolerance of each dispositive | Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable) | Hours 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea scale of Borg | Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: very light, difficult, painful ... effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF). | Hours 6 | 
| Dyspnea scale of Borg | Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: very light, difficult, painful ... effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF). | Hours 24 | 
| Dyspnea scale of Borg | Dyspnea score which is a quantitative measure of the perception of effort during a physical exercise. The measure is a rating on a scale from 0 to 10 attached to different words of appreciation: very light, difficult, painful ... effort. This global measurement, based on the physical and psychological sensations of the person, takes into account the physical condition, the environmental conditions and the level of general fatigue. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the CF). | Hours 48 | 
| Treatment's failure defined as use of NVI in HFO group or use of HFO in NVI group | defined by reintubation or exchange of treatment or premature discontinuation of treatment | Month 3 | 
| Hematosis : PaO2, PaCO2, pH | Measurement of PaO2, PaCO2 and pH | hours 6 | 
| Hematosis : PaO2, PaCO2, pH | Measurement of PaO2, PaCO2 and pH | hours 24 | 
| Hematosis : PaO2, PaCO2, pH | Measurement of PaO2, PaCO2 and pH | hours 48 | 
| Duration of hospitalization in intensive care units, reanimation, hospital after extubation. | Measurement of hospitalization in intensive care units in days | Month 3 | 
| Mortality in ICU (continuous monitoring unit) | Measurement of mortality | Month 3 | 
| Mortality in hospital | Measurement of mortality | Month 3 | 
| Mortality at M1 and M3 | Measurement of mortality | Month 1 | 
| Mortality at M1 and M3 | Measurement of mortality | Month 3 | 
| Use of another technic (HFO or NVI) in time | Duration of use of the device (VNI, OHD) at H72 | hours 72 | 
| Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis) | Measurement of respiratory congestion by : number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults and radiological atelectasis | month 3 | 
| New intubation rate at H48 | New intubation rate at H48 | Hours 48 | 
| New intubation rate at H72 | New intubation rate at H72 | Hours 72 | 
| SpO2 stability | Percentage of time spent below 88% and above 92% of SpO2 | hours 48 | 
| SpO2 stability | Percentage of time spent below 88% and above 92% of SpO2 | hours 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Flow Oxygen, Non Invasive Ventilation, Automated Flow Oxygen Titration, respiratory risk