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临床试验/NCT03379350
NCT03379350已完成不适用

The Impacts of Intermittent Chest Tube Clamping on Chest Tube Drainage Duration and Postoperative Hospital Stay After Lung Cancer Surgery: A Prospective Study

Wu Nan1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年7月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
chest tube drainage duration

研究概览

简要总结

All patients undergo lateral thoracotomy or video-assisted thoracoscopic surgery (VATS) and are operated on by the same thoracic surgical team. All patients are managed with gravity drainage (water seal only, without suction) on the day of operation. Eligible patients are randomized to control group or clamping group at a 1:1 ratio before 3pm on the postoperative day. Patients in control group and those in clamping group are managed with different protocols after 3pm on the postoperative day.

详细描述

All patients undergo lateral thoracotomy or video-assisted thoracoscopic surgery (VATS) and are operated on by the same thoracic surgical team. At the end of operation, the lung parenchyma is submerged in sterile saline to test for air leakage, and a single 24-Fr chest tube is placed in each patient. All patients are managed with gravity drainage (water seal only, without suction) on the day of operation.

Once a radiograph is confirmed re-expansion of the lung on the morning of the first postoperative day and no air leak is detected, the patient is a candidate for inclusion in the trial. Eligible patients are randomized to control group or clamping group before 3pm on the postoperative day.

Patients in control group are managed with gravity drainage unchangeably, while patients in clamping group are managed with clamping protocol after 3pm on the postoperative day as follow: the chest tube will be clamped, and the nurses will check the patient every 6 h. If the patient has no problems with compliance, the clamp will be removed for half an hour in the morning to record the drainage volume every 24 h. If patients develops intolerable abnormal symptoms, such as dyspnea, pneumothorax, and severe subcutaneous emphysema after chest tube clamping, the clamp will be removed for 30 min and be reapplied after the symptoms have been resolved. Such patients will be placed under more rigorous surveillance after re-clamping, which requires the medical staff to check on the patients every 2-4 hours in order to promptly detect abnormal symptoms. If abnormal symptoms occur frequently, this clamping protocol will be continued until another radiograph excluded the presence of pneumothorax.

The daily output of pleural fluid was recorded. The criteria for chest tube removal were as follows: (a) drainage volume≤250 mL in 24 h, (b) absence of air leakage and intrathoracic hemorrhage, and (c) absence of signs of purulent pleural effusion and atelectasis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pathological diagnosis of lung cancer Treated with lobectomy and systematic mediastinal lymph node dissection/ systematic sampling Managed with gravity drainage (water seal only, without suction) Re-expansion of the lung confirmed on the morning of the first postoperative day

排除标准

  • •Thoracic cavity infection Prolonged air leakage Reoperation due to chylothorax Atelectasis Liver cirrhosis Renal insufficiency Wound infection

研究组 & 干预措施

clamping group

Experimental

Clamping group are managed with clamping protocol after 3pm on the postoperative day as follow: the chest tube will be clamped, and the nurses will check the patient every 6 h. If the patient has no problems with compliance, the clamp will be removed for half an hour in the morning to record the drainage volume every 24 h.

干预措施: clamping group (Procedure)

control group

No Intervention

Patients in control group are managed with gravity drainage (water seal only, without suction) all the time after operation.

结局指标

主要结局

chest tube drainage duration

时间窗: From date of operation until the date of chest tube removal, assessed up to 10 days

time from operation day to the day of chest tube removal

次要结局

  • postoperative hospital stay(From date of operation until the date of hospital discharge, assessed up to 2 weeks)

研究者

发起方
Wu Nan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wu Nan

Assistant of hospital director

Peking University Cancer Hospital & Institute

研究点 (1)

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