Non-Invasive Ventilation With Neurally Adjusted Ventilatory Assist vs NIV Pressure Support or Pressure Control in Treatment of Patients With Acute Respiratory Insufficiency. A Prospective, Randomised, Single Blinded, Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).
研究概览
简要总结
This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure Support (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4 hours. Afterwards they will be subjected to a semi-structured interview where they will be asked to compare the two modes. The hypothesis is that NIV-NAVA will correct patients power of Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable for the patients.
详细描述
Neurally Adjusted Ventilatory Assist (NAVA) is a ventilation mode where the diaphragm is controlling the amount of ventilatory assistance proportionally through a nasogastric tube containing electrodes which are sending the electrical activities of the diaphragm (Eadi) to the ventilator.
Whereas Conventional ventilation modes like Pressure support or Pressure Control are dependent on the pressure drop or flow reversal to initiate assist delivered to the patient. This is last step of the signal chain leading to inhalation and is subject to disturbances such as intrinsic positive expiratory end pressure (PEEP), hyperinflation and leakage.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients admitted at the ICU with acute respiratory insufficiency and therefore have hypoxia(PaO2 < 7 kPa on atmospheric air) og pH < 7.35 with non-compensated hypercapnia (PaCO2 > 6.0 kPa).
- •Patients, which according to the departments guidelines are required to treatment with NIV
排除标准
- •Patients under years of
- •Patients without the possibility to give informed consent.
- •Patients with neuromuscular or neurological disease.
- •Patients with a verified or suspected head trauma.
- •Patients with a acknowledged hiatus hernia.
- •Patients with an active or suspected active upper GI bleeding.
- •Patients which have previously been in the study.
- •Patients with a suspected or verified acute coronary syndrome.
结局指标
主要结局
Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).
时间窗: 8 hours
Time for normalizing of Partial pressure of Oxygen (pO2) in arterial blood gases. Normal frame for pO2 7-14,4 (or to the usual level for the patient).
时间窗: 8 hours
Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.
时间窗: 8 hours
Time for normalizing Carbon dioxide partial pressure (pCO2) in arterial blood gases. Normal frames pCO2 4,7-6,4 (or to the usual level for the patient).
时间窗: 8 hours
次要结局
- Patient comfort(24 hours)