Anesthetics to Prevent Lung Injury in Cardiac Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
研究概览
简要总结
The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac surgery.
详细描述
Randomized, controlled trial involving 45 adult patients undergoing cardiac surgery with cardiopulmonary bypass. Patients will be randomized to receive either inhaled anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol for the maintenance phase of their cardiac anesthetic. Assessment of lung inflammation will take place using fiberoptic bronchoscopic sampling of lung fluid as well as serum collection before and after exposure to cardiopulmonary bypass, and the incidence of compositive postoperative pulmonary complications will take place in the postoperative period.
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 (Outcomes Assessor)
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
- •Adult patients (age 18+)
- •Undergoing cardiac surgery with cardiopulmonary bypass
排除标准
- •Emergency surgery
- •History of severe COPD, emphysema, or ILD
- •Recent (<2wk) or current use of systemic glucocorticoids
- •Prior history of pneumothorax
- •Allergy/contraindication to intravenous anesthetics
- •Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
研究组 & 干预措施
Inhaled Anesthesia
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
干预措施: Sevoflurane (Drug)
Intravenous Anesthesia
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
干预措施: Propofol (Drug)
结局指标
主要结局
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
时间窗: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Inflammatory mediator found in BAL fluid during lung inflammation
次要结局
- Number of Patients With Postoperative Pulmonary Complications(Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up.)
- BAL Concentration of IL1b (pg/mL)(Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass)
- BAL Concentration of IL6 (pg/mL)(Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass)
- BAL Concentration of IL8 (pg/mL)(Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass)
- BAL Concentration of MCP1 (pg/mL)(Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass)
- BAL Concentration of sRAGE (pg/mL)(Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass)
研究者
Brian O'Gara
MD
Beth Israel Deaconess Medical Center