Randomized Control Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Incidence of intraoperative central venous line insertion
研究概览
简要总结
This is a prospective randomized controlled trial looking at the utility of intraoperative transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy. Patients in the control group will have standard of care, patients in the TEE group will have standard of care and TEE monitoring throughout. Intraoperative and postoperative variables, such time to extubation, postoperative cardiac and pulmonary complications, intraoperative fluid and vasopressor use will be assessed.
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
- None
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 have elective radical cystectomy at The University of Chicago Hospital.
排除标准
- •Patient refusal, emergent surgery, preoperative mechanical ventilation, preoperative hemodynamic instability (intravenous vasopressor support), and/or esophageal/gastric pathology contraindicating insertion of the transesophageal echocardiography probe.
研究组 & 干预措施
Control
Standard of care, no intervention
Transesophageal echocardiography
Patients will have intraoperative transesophageal echocardiography along with standard of care for management.
干预措施: Transesophageal echocardiography (Other)
结局指标
主要结局
Incidence of intraoperative central venous line insertion
时间窗: 1 day after study enrollment
postoperative return of bowel function via flatus or passage of stool
时间窗: 5 days after study enrollment
次要结局
- Decreased postoperative pulmonary and cardiac complications(approximately 5-7 days)