Efficacy of Volume Targeted Pressure Support Ventilation vs. Pressure Support Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Resolution of hypercapnia
研究概览
简要总结
This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. This study focuses on patients at risk of obstructive apneas or obesity-hypoventilation syndrom (BMI≥30 kg/m²). Half of participants (33 patients) will receive non invasive ventilation with AVAPS-AE mode, the other half will receive non-invasive ventilation with S/T mode.
详细描述
So far, in respiratory intensive care units, the usual treatment of patients with acute hypercapnic respiratory failure with acidosis is non-invasive ventilation set with a pressure support mode (S/T or VS/AI mode depending on the ventilator manufacturer).
AVAPS-AE mode is a volume targeted pressure support mode with an automatic PEP. With the forced oscillations method, the ventilator is able to detect the obstruction and the resistances of upper airways.
It allows the ventilator to change its pressure settings to keep the targeted volume and avoid apneas and hypoventilation.
That is why in patients with a BMI > 30 kg/m², at risk of obesity hypoventilation syndrom or obstructive apneas, this ventilation mode may be interesting.
AVAPS-AE has been evaluated in the home ventilation showing it is as efficient as S/T mode in controlling PaCO2.
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
- Single (Participant)
盲法说明
The ventilator used in both arms will be similar in appareance.
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 of age
- •Patient benefitting of social security
- •Informed patient who signed the information note and the research enlighted consent form
- •Admission in respiratory intensive care unit for an acid-hypercapnic exacerbation (defined by pH≤ 7,35)
- •BMI ≥ 30kg/m2
- •PaCO2 > 6.5 kPa on blood gases at ICU admission
排除标准
- •Confirmed COPD with a spirometry (VEMS/CVF < 70%)
- •Pregnant women, or breast-feeding women
- •Patient with a judiciary or administrative liberty deprivation
- •Patients under guardianship
- •Contraindication to NIV
研究组 & 干预措施
AVAPS-AE mode
A volume targeted pressure support ventilation mode
干预措施: AVAPS-AE mode during NIV (Device)
S/T mode
A pressure support ventilation mode
干预措施: S/T mode during NIV (Device)
结局指标
主要结局
Resolution of hypercapnia
时间窗: through study completion, an average of 1 year
Time between admission and resolution of hypercapnia (≤ 6.5 kPa)
次要结局
- Comparison of persistent apneic events on NIV (/h) during the first night(through study completion, an average of 1 year)
- Comparison of time during NIV with a oxygen saturation below 90%(through study completion, an average of 1 year)
- Comparison of NIV confort(through study completion, an average of 1 year)
- Comparison of patient-ventilator asynchronisms during NIV (/h)(through study completion, an average of 1 year)
- Comparison of length of stay(through study completion, an average of 1 year)