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临床试验/NCT04012554
NCT04012554Unknown不适用

The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS)of the Lung

Xueying Yang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
operation time

研究概览

简要总结

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after Video-Assisted Thoracoscopic Surgery lung disease,participants were randomly divided into experimental group and control group.Avoiding chest tube placement after VATS of the lung in the experimental group.Indwelling thoracic drainage tube after VATS of the lung in the control group.

详细描述

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,divided into experiment group and control group.Communicating with surgeon and patients who met the inclusion criteria,decided whether to enter the experimental group or control group. Experimental group avoid chest tube placement after VATS of the lung and control group indwell thoracic drainage tube after VATS of the lung.By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the treatment of avoiding chest tube placement after VATS of the lung is more beneficial than the conventional indwell thoracic drainage tube after VATS of the lung,and it's safe and feasible.

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
Single (Outcomes Assessor)

盲法说明

This is a randomized controlled trial.Partcipants,Care Provider, and Investigator all know the grouping situation.The Investigator collect the information and observation indicators of the two groups of participant and send the outcomes.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.Age ranges from 18 to 75 years old,do the examination of chest CT showed pulmonary disease,no invasion of peripheral blood vessels and viscera,no pleural effusion and pericardial effusion.
  • 2.Electrocardiogram, pulmonary function,color doppler ultrasound of the heart,arteries and veins of both lower limbs are normal,no potential infection was confirmed before surgery, no serious organic disease of the heart and lung,and no obvious operation contrain.

排除标准

  • 1.The lungs continue to leak air preoperation more than six days. 2.The appearment of the hemothorax,empyema and chylothorax preoperative. 3.The appearment of the preoperative chest X-ray pulmonary atelectasis and pulmonary infection.
  • 4.The lungs leak air appears in the surgery. 5.Patients with severe cardiovascular and cerebrovascular accident after operation were terminated.
  • 6.Impaired lung function (forced expiratory volume in 1 second [FEV1]<60% predicted).

结局指标

主要结局

operation time

时间窗: 1 day

From the beginnning of ansesthesia to the end of anesthesia

hospitalization expenses

时间窗: 15 days

the total cost of hospitalzation

postoperative complication rate

时间窗: a month

incidence of postoperative complications such as pneumothorax and hydrohorax

VAS pain scores

时间窗: 3 days

the VAS pain score was given to patients and the pain scores were recorded at 6h,12h,24h,48h,and 72h postoperatively.The minimum score is 0 and the maximum score is 10.The high values represent a worse outcome.

postoperative extubation time

时间窗: 1 day

postoperative extubation time

duration of postoperation pain

时间窗: 10 days

postoperative pain duration

the time of early ambulation after operation

时间窗: 1 day

the time from the patient's postoperative pushback to the first bedtime

次要结局

未报告次要终点

研究者

发起方
Xueying Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xueying Yang

professor

Shengjing Hospital

研究点 (1)

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