Local Side Effects of Transesophageal Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- incidence of endoscopic mild mucosal injury
研究概览
简要总结
Transesophageal echocardiography is commonly used during cardiac surgery. Complications of transesophageal echocardiography are rare (1,2%), but are often underestimated and can lead to unrecognized blood loss and site of infection.
This study wants to assess the mucosa of pharynx, upper larynx, esophagus and stomach prior to and after echo probe insertion during cardiac surgery with endoscopy.
详细描述
Transesophageal echocardiography is commonly used during cardiac surgery. Main reasons for its use are the evaluation of cardiac function and valve morphology previous to and after cardiac surgery.
Complications of transesophageal echocardiography are rare (1,2%). Described complications may involve the gastrointestinal, cardiovascular or respiratory system.
The major complication of transesophageal echocardiography is local injury of the GI tract. Only massive bleeding and perforation were reported, minor injuries are not noticed in the early postoperative period but may play an important role, especially in patients discomfort, source of minor unrecognized blood loss and site of infection. As oropharyngeal bacteria are known to cause endocarditis and graft infection, this site of infection may be of special interest in cardiac surgery.
Study objectives:
To assess the mucosa of pharynx, upper larynx, esophagus and stomach prior to and after TEE probe insertion during cardiac surgery using flexible endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
the investigator doing the transesophageal examination will not be informed about the results of the endoscopy
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
- •Planned cardiac surgery
- •Age above 18 years
- •Signed informed consent
- •Clinical need for intraoperative use of transesophageal echocardiography
排除标准
- •Recent gastrointestinal pathologies (3-6 months)
- •Recent operations of the upper gastrointestinal tract (3-6 months)
- •Subjects not able to understand study procedures
- •No signed informed consent
- •Contraindications for transesophageal echocardiography
- •Antibiotic treatment within three months prior to surgery
研究组 & 干预措施
endoscopy
endoscopy of the upper GI tract
干预措施: endoscopy (Diagnostic Test)
结局指标
主要结局
incidence of endoscopic mild mucosal injury
时间窗: 7-8 hours
erythema, edema, hematoma, mucosal erosion, petechiae, or perforation of the upper GI mucosa
次要结局
- length of examination(1 day)
- incidence of postoperative complications(up to 1 week)
研究者
Ulrike Weber
Ass.Prof.Dr.
Medical University of Vienna