Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Lung Injury Score.
研究概览
简要总结
The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Preventive non invasive ventilation
Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
干预措施: Non invasive ventilation (Procedure)
Preventive non invasive ventilation
Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
干预措施: monitoring system Pulse-Induced Contour Cardiac Output (Picco) (Procedure)
Preventive non invasive ventilation
Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
干预措施: Computed tomography (CT) (Procedure)
Preventive non invasive ventilation
Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
干预措施: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10) (Other)
Non invasive ventilation on demand
Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
干预措施: monitoring system Pulse-Induced Contour Cardiac Output (Picco) (Procedure)
Non invasive ventilation on demand
Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
干预措施: Computed tomography (CT) (Procedure)
Non invasive ventilation on demand
Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
干预措施: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10) (Other)
Non invasive ventilation on demand
Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
干预措施: Non invasive ventilation (Procedure)
结局指标
主要结局
Lung Injury Score.
时间窗: Daily during hospitalization in the PACU on day 1 to 7.
次要结局
- Doppler pulsatility of the portal vein and its pulsatility ratio(2 years)
- Computed tomography (CT) score(2 years)
- Pulmonary Vascular Index (PVI) measures(2 years)
- Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).(2 years)
- Extravascular Lung Water (EVLW) measures.(2 years)