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

Not Applicable

• Conditions: Lung Diseases

• Registration Number: NCT04012554
• Lead Sponsor: Xueying Yang

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-06
• Last Update Posted: 2019-10-08
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS pain scores	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	1 day	postoperative extubation time
operation time	1 day	From the beginnning of ansesthesia to the end of anesthesia
hospitalization expenses	15 days	the total cost of hospitalzation
duration of postoperation pain	10 days	postoperative pain duration
the time of early ambulation after operation	1 day	the time from the patient's postoperative pushback to the first bedtime
postoperative complication rate	a month	incidence of postoperative complications such as pneumothorax and hydrohorax

Trial Locations

Locations (1)

The Fourth Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China