Improved Drainage Strategy for Patients With Lung Wedge Resection

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Drainage

Treatments: Procedure: Complete omission of chest tube; Procedure: Improved drainage strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04207671

TBL-2

Details and patient eligibility

About

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.

Full 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% 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Omission of chest tube

Other group

Description:

After wedge resection and the air-leak test, patients will receive complete omission of chest tube and directly close the incision.

Treatment:

Procedure: Complete omission of chest tube

Improved drainage strategy

Experimental group

Description:

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.

Treatment:

Procedure: Improved drainage strategy