Does Inhaled Salbutamol Prevent Lung Edema After Thoracic Surgery? A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- reduction in extravascular lung water
研究概览
简要总结
Background :
Acute lung injury (ALI) occasionally occurs after pulmonary resection and carries a bad prognosis with a high mortality rate ranging from 20 to 100%.
Objectives :
- to evaluate pre-, intra- and postoperative changes in hemodynamics, oxygenation indices as well as intra- and extravascular lung water using simple thermodilution technique and continuous arterial pressure analysis
- to test the efficacy of inhaled beta2 -adrenergic agonist versus anticholinergic agents to reduce lung edema in patients undergoing thoracic surgery and in pigs subjected to lipolysacharide-induced ALI.
Design of the research protocol:
- Prospective controlled trial including surgical patients with high risk factors for ALI (n=60) allocated to receive inhaled drugs (randomised, double-blind, cross-over mode).
- Main measurements:
Intra-thoracic blood volume, intra- and extra-vascular lung water, hemodynamic parameters (CO, systolic arterial pressure/flow variations, dPmax, MAP, CVP), oxygenation indices (PaO2/FIO2), ventilatory parameters, clinical outcome data, histochemical and pathological data.
Glossary CO = cardiac output; dPmax = maximal arterial pressure slope; SAP-V = systolic arterial pressure variations; Flow-V = Flow variations; MAP = mean arterial pressure; CVP = central venous pressure; PaO2=arterial oxygen pressure; FIO2= oxygen inspiratory fraction
详细描述
Material and Methods Patient selection Consecutive patients who require elective lung resection for cancer at the University Hospital of Geneva will be screened for the presence of risk factors for postoperative ALI or hydrostatic lung edema: age > 60 yrs, history of chronic alcohol consumption (>60g/day), prior radiation or chemotherapy, cardiac insufficiency (left ventricular ejection fraction < 40%, or a history of past acute heart failure), coronary artery disease (history of myocardial infarct, Q wave on the ECG, positive stress test or coronary angiogram), recent pneumonia (within 6 weeks of hospital admission), reduced diffusion capacity for carbon monoxide (DLCO < 60% of predicted values) and predicted postoperative lung perfusion of < 55% of total lung perfusion. Patients with at least 3 risk factors for postoperative lung edema will be considered eligible for the study. Patients undergoing pneumonectomy or presenting with intracardiac shunts, valvular diseases or aortic abdominal aneurysm will all be excluded as these conditions preclude valid measurements of extravascular lung water volumes. In addition, chronic treatment with inhaled bronchodilators, a history of any adverse reaction to bronchodilators and liver or kidney insufficiencies will be considered exclusion criteria.
This randomized double blind, cross-over study has been approved by the local university hospital ethics committee and written informed consent has been obtained from all selected patients.
The same team of pneumonologists, thoracic surgeons and anesthesiologists/intensive care physicians will be involved in the perioperative medical management. In addition to history and clinical examination, a standardized preoperative assessment includes chest radiography, ECG, pulmonary function testing as well as computed tomography scans and positron emission tomographies of the chest, abdomen and brain. Quantitative lung perfusion/ventilation scanning, brain imaging, maximal aerobic capacity and myocardial stress testing will be performed when appropriate in intermediate-to-high risk surgical candidates.
Operative and anesthetic management Routinely, antimicrobial prophylaxis with cefazoline will be administered for 24 hours and an epidural catheter was inserted at the 4th-5th or at the 5th-6th vertebral interspace. Thoracic epidural anesthesia (TEA) will be initiated preoperatively with the administration of bupivacaïne 0.25% and continued postoperatively with a lower dosage (bupivacaine 0.1%) that was combined with opiates (fentanyl 2 mcg/ml).
Each patient will be equipped with a 4-French femoral artery catheter and an internal jugular venous line that will be connected to a pulse contour cardiac output monitor (PV2024L; Pulsion Medical Systems AG, Munich, Germany).
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
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 3 risk factors for postoperative lung edema
- •age > 60 yrs
- •history of chronic alcohol consumption (>60g/day)
- •prior radiation or chemotherapy
- •cardiac insufficiency (left ventricular ejection fraction < 40%, or a history of past acute heart failure)
- •coronary artery disease (history of myocardial infarct, Q wave on the ECG, positive stress test or coronary angiogram)
- •recent pneumonia (within 6 weeks of hospital admission)
- •reduced diffusion capacity for carbon monoxide (DLCO < 60% of predicted values)
- •predicted postoperative lung perfusion of < 55% of total lung perfusion
排除标准
- •pneumonectomy
- •intracardiac shunts
- •valvular diseases
- •aortic abdominal aneurysm
- •chronic treatment with inhaled bronchodilators
- •a history of any adverse reaction to bronchodilators
- •liver or kidney insufficiencies
结局指标
主要结局
reduction in extravascular lung water
时间窗: within the first 24 hours after lung surgery
次要结局
- changes in oxygenation indices, hemodynamics and radiological lung injury score(within the first 48 hours)
