Two-Lumen Catheterization For Lung Wedge Resection

Not Applicable

• Conditions: Thoracic Surgery, Video-Assisted

• Registration Number: NCT03230019
• Lead Sponsor: Wen-zhao ZHONG

Brief Summary

This study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove.

Detailed Description

With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades. The concept of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest tube placement. Chest tube placement always causes pain, and its duration is known to be one of the most important factors influencing hospital stay and costs. Early tube removal allows patients to breathe deeply with less pain, which leads to more compliance with chest physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory function. Hence, more and more experienced surgeons choose the omission of chest tube placement after lung wedge resection. However, based on previous retrospective studies, residual pneumothorax was noted in about 10\~40% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization for remedial gas-remove. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection.

Study Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-23
• Study First Posted: 2017-07-26
• Study Start: 2017-08-25
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-10
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm
2. Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis

Exclusion Criteria

1. Previous ipsilateral thoracic surgery or extensive adhesion
2. Preoperative radiology revealed pneumonia or atelectasis
3. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
4. Bleeding tendency or anticoagulant use
5. Pregnancy or breast feeding
6. Patient who can not sign permit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative adverse event incidence rate	1 months	To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (\>800ml) in both groups.
Rate of post-operative related complications	1 week	To evaluate the rate of post-operative related complications within 7 days of surgery
Length of post-operative hospital stay	1 week	To evaluate the length of post-operative hospital stay

Secondary Outcome Measures

Name	Time	Method
Postoperative wound satisfaction	1 month	To evaluate the post-operative wound healing condition .
The time of post-operative extubation	1 week	To evaluate the time of duration of chest tube or catheterization.
Postoperative pulmonary function recovery	1 week	To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.
Postoperative pneumoderm incidence rate	3 days	To evaluate the postoperative pneumoderm incidence rate in both groups.
Postoperative pain score	1 day	To evaluate the pain score via NRS pain scale first day after surgery.

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China