Two-Lumen Catheterization For Lung Wedge Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial

Conditions
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Thoracic Surgery, Video-Assisted

Intervention / Treatment
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* Procedure: chest tube
* Procedure: two-lumen catheterization
* Device: two-lumen catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis Exclusion Criteria: Previous ipsilateral thoracic surgery or extensive adhesion Preoperative radiology revealed pneumonia or atelectasis 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). Bleeding tendency or anticoagulant use Pregnancy or breast feeding Patient who can not sign permit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chest tube<br>VATS with chest tube placement | Procedure: chest tube<br>* VATS with chest tube placement<br>|
| Experimental: two-lumen catheter<br>VATS with two-lumen catheterization | Procedure: two-lumen catheterization<br>* VATS with two-lumen catheterization long the midclavicular line, second intercostal space<br>Device: two-lumen catheter<br>* central venous catheter(two-lumen 7-Fr-20cm)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wedge resection, tubeless