Improved Drainage Strategy for Patients With 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 complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, 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% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization as improved drainage strategy. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus omission of chest tube placement in patients with lung wedge resection.

Official Title
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Omission of Chest Tube Versus Improved Drainage Strategy in Patients With Lung Wedge Resection: A Prospective Randomized Trial

Conditions
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Drainage

Intervention / Treatment
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* Procedure: Complete omission of chest tube
* Procedure: Improved drainage strategy


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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Omission of chest tube<br>After wedge resection and the air-leak test, patients will receive complete omission of chest tube and directly close the incision. | Procedure: Complete omission of chest tube<br>* No chest tube implacement<br>|
| Experimental: Improved drainage strategy<br>After wedge resection and the air-leak test, patients willreceive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-removal. | Procedure: Improved drainage strategy<br>* A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of massive pneumothorax on day 1 after surgery | To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on day 1 after surgery | To evaluate the pain score via numerical rating scale on day 1 after surgery. An 11-point numeric scale (NRS 11) with 0 representing no pain and 10 representing worst pain imaginable. | 1 day | 
| Length of post-operative hospital stay | To evaluate the length of post-operative hospital stay. | 1 week | 
| Postoperative pulmonary function recovery | To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tubeless, Wedge resection, Improved drainage strategy