跳至主要内容
临床试验/NCT03598296
NCT03598296已完成不适用

Comparison of the Results of Two Chest Tube Management During an Enhanced Recovery Program After Video-Assisted Thoracoscopic Lobectomy.

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月28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
60
试验地点
1
主要终点
Hospitalization days

研究概览

简要总结

Comparing the influences of different chest tube managements for enhanced recovery program after video-Assisted thoracoscopic lobectomy.

详细描述

The Enhanced Recovery Program has a series of observation data contains hospitalization days, adverse events, drainage, extubation, visual analogue scale(VAS) scores and the number of analgesic using.The investigators plan to enroll 60 patients and divide them into two groups to compare the influences of different chest tube managements for enhanced recovery program after video-assisted thoracoscopic lobectomy.

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
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only single lesion on the targeted lobe
  • Considered as invasive carcinoma by preoperative computed tomography (CT) or -diagnosed by intraoperative pathology
  • Patients have signed informed consent.

排除标准

  • Patients have critical basic disease(diabetes and hypertension).
  • Patients who lung function cannot undertake the lobectomy.
  • The lesion has the possibility of metastasis.
  • Finding serious adhesion to pleura during operation

研究组 & 干预措施

Group A:Group Tube

Experimental

Patients are inserted the large size tube (28F).Patients undergo upper lobectomy are inserted one additional large size tube(28F,we named this tube upper tube).This group is planned to enroll 30 patients.

干预措施: Large size tube (Other)

Group B:Group Ball

Experimental

Patients are inserted the small size tube connects with a negative pressure ball(drainage ball).Patients undergo upper lobectomy are inserted one additional large size tube(28F,we named this tube upper tube).This group is planned to enroll 30 patients.

干预措施: Drainage ball (Other)

结局指标

主要结局

Hospitalization days

时间窗: From the first days after surgery to discharge,up to 4 weeks.

The numbers of days of patients stay in the hospital after surgery

次要结局

  • Drainage(Measure the volume every 24 hours,up to 4 weeks)
  • Analgesics(Counting the total analgesics using times through study completion, an average of 3 months.)
  • Adverse event(Counting the times of adverse events through study completion, an average of 3 months.)
  • Pulmonary recruitment(The first 24 hours after surgery and 8 hours before leaving hospital.)
  • VAS scores(Pain is measured by VAS on the first 24 hours of after operation and the first 24 hours after tube removing.)

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验