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
- 1
- 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
- •Age ≥ 18 years
- •First and /or second procedure of pulmonary artery angioplasty
- •Mean pulmonary arterial pressure ≥ 40 mmHg and/or pulmonary vascular resistance ≥ 8 WU (Wood unit)
- •Patient who signed informed consent
- •Patients affiliated to a social security program
排除标准
- •severe neurological disease: Coma Glasgow Scale < 8, severe cognitive decline, postural instability, loss of autonomy.
- •psychiatric disease (illness)
- •sepsis, severe sepsis and septic shock, according to definitions and diagnostic criteria for sepsis of 'Surviving Sepsis Campaign 2012'
- •severe respiratory failure defined by a total lung capacity (TLC)< 50% of the predicted value and/or expiratory volume in 1 second (FEV) < 30% of predicted value
- •obstructive sleep apnea syndrome with Continuous Positive Airway treatment
- •preexisting hemorrhagic syndrome or coagulation factors deficiency
- •severe renal insufficiency with glomerular filtration rate < 30 ml/min
- •severe hepatic failure with hepatic encephalopathy, hemodynamic disorder, decompensates cirrhosis, metabolic disorder( metabolic acidosis, hypoglycemia) hepatorenal syndrome, coagulation disorder (factor V< 50%,disseminated intravascular coagulation)
- •patient refusal of participation in the study program
- •subjects not affiliated to social security program
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
- Computed tomography (CT) score(2 years)
- Pulmonary Vascular Index (PVI) measures(2 years)
- Doppler pulsatility of the portal vein and its pulsatility ratio(2 years)
- Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).(2 years)
- Extravascular Lung Water (EVLW) measures.(2 years)