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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Primary outcome: Tolerance of each dispositive
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High Flow Oxygen (HFO)
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.
干预措施: High Flow Oxygen (HFO) (Device)
Non Invasive Ventilation (NIV)
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
干预措施: Non Invasive Ventilation (NIV) (Device)
结局指标
主要结局
Primary outcome: Tolerance of each dispositive
时间窗: Hours 48
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive
时间窗: Hours 0
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive
时间窗: Hours 6
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
Primary outcome: Tolerance of each dispositive
时间窗: Hours 24
Comfort scale (from 0 to 100 : 0 is totally uncomfortable - 100 : comfortable)
次要结局
- Mortality at M1 and M3(Month 3)
- Use of another technic (HFO or NVI) in time(hours 72)
- Respiratory congestion (number of fibroscopy for airway's desobstruction, number of respiratory kinesitherapy consults, radiological atelectasis)(month 3)
- New intubation rate at H48(Hours 48)
- New intubation rate at H72(Hours 72)
- Dyspnea scale of Borg(Hours 48)
- Treatment's failure defined as use of NVI in HFO group or use of HFO in NVI group(Month 3)
- Hematosis : PaO2, PaCO2, pH(hours 48)
- Duration of hospitalization in intensive care units, reanimation, hospital after extubation.(Month 3)
- Mortality in hospital(Month 3)
- Mortality in ICU (continuous monitoring unit)(Month 3)
- SpO2 stability(hours 72)
- Mortality at M1 and M3(Month 1)
- Hematosis : PaO2, PaCO2, pH(hours 6)
- Hematosis : PaO2, PaCO2, pH(hours 24)
- Dyspnea scale of Borg(Hours 6)
- Dyspnea scale of Borg(Hours 24)
- SpO2 stability(hours 48)