Improved Drainage Strategy for Patients With Lung Wedge Resection

Not Applicable

• Conditions: Drainage
• Interventions: Procedure: Improved drainage strategy; Procedure: Complete omission of chest tube

• Registration Number: NCT04207671
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07
• Study Start: 2020-03
• Primary Completion: 2022-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Arm && Interventions

Group	Intervention	Description
Improved drainage strategy	Improved drainage strategy	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.
Omission of chest tube	Complete omission of chest tube	After wedge resection and the air-leak test, patients will receive complete omission of chest tube and directly close the incision.

Primary Outcome Measures

Name	Time	Method
The incidence rate of massive pneumothorax on day 1 after surgery	1 day	To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray)

Secondary Outcome Measures

Name	Time	Method
Pain score on day 1 after surgery	1 day	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.
Length of post-operative hospital stay	1 week	To evaluate the length of post-operative hospital stay.
Postoperative pulmonary function recovery	1 month	To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.