Safety and Efficacy of Awake Uniportal Video Assisted Thoracoscopic Modified Pericardial Window in Recurrent Pericardial Effusion at Mid Term Result
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- recurrence of pericardial effusion
研究概览
简要总结
this study compare two surgical techniues at the same time two methods of anathesia with assisstance of thoracoscope for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months
详细描述
this study compare two thoracoscopic techniues awake modified pericardial window and pericardial window under general anasethia for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who presented with recurrent massive pericardial effusion based on clinical, radiological evidence by Echo and C.T. chest
排除标准
- •hemodynamically unstable patients
研究组 & 干预措施
General traditional pericardial window
A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook
干预措施: traditional pericardial window (Procedure)
Awake modified pericardial window
H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium
干预措施: modified pericardial window (Procedure)
结局指标
主要结局
recurrence of pericardial effusion
时间窗: follow up each month at out patient clinic for 6 months from the date of surgery
clinical (Beck's triad:Hypotension with a narrowed pulse pressure,jugular venous distension,distant heart sounds )and Echo findings suggestive of recurrence of pericardial effusion
Awake anasethia
时间窗: from the start till the end of the procedure about 45 min
the patient is sedated -cooperative- hemodynamically stable by transthoracic spinal anasthsia at Cervical 5
次要结局
未报告次要终点
研究者
Amr Elsayed Tawfek Ibrahim
assisstant professor
Zagazig University