Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Carbon dioxide arterial pressure (PaCO2)
研究概览
简要总结
VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis.
This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve.
Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours.
Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Dioxide carbon arterial pressure > 60 mmHg
- •Blood acidity (pH) <7.36
排除标准
- •Patient age under 18
- •Pregnant woman
- •Cognitive disorder (other than the one induced by hypercapnia)
- •Acute intoxication with morphine or benzodiazepines
- •Patient already equipped prior to admission with a home NIV or Continuous Positive Airway Pressure (CPAP) device
- •All contraindications to NIV already described in the French Consensus Conference on NIV, from 2006.
研究组 & 干预措施
Homecare ventilator
NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak)
干预措施: Non-Invasive Ventilation with Homecare ventilator (Procedure)
ICU ventilator
NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve.
干预措施: Non-Invasive Ventilation with ICU ventilator (Procedure)
结局指标
主要结局
Carbon dioxide arterial pressure (PaCO2)
时间窗: After 2 hours of NIV
Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation
次要结局
- Arterial blood acidity (pH) after 2 hours of NIV(after 2 hours of NIV)
- Transcutaneous PCO2(6 hours)
- Börg dyspnea scale(6 hours)
- RASS score(6 hours)
- Nurse satisfaction survey(6 hours)
- Patient satisfaction survey(6 hours)