Improved Drainage Strategy for Patients With Lung Wedge Resection

Drainage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04207671
• Other study ID #: TBL-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: May 2022

Study information

• Verified date: January 2020
• Source: Guangdong Provincial People's Hospital
• Contact: Jia-Tao Zhang, Ph.D
• Phone: +86-83827812-51311
• Email: 18820792959[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drainage

Intervention

Procedure:
• Complete omission of chest tube
No chest tube implacement
• Improved drainage strategy
A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

References & Publications (1)

Zhang JT, Tang YC, Lin JT, Dong S, Nie Q, Jiang BY, Yan HH, Wen ZW, Wu Y, Yang XN, Wu YL, Zhong WZ. Prophylactic air-extraction strategy after thoracoscopic wedge resection. Thorac Cancer. 2018 Nov;9(11):1406-1412. doi: 10.1111/1759-7714.12850. Epub 2018 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Length of post-operative hospital stay	To evaluate the length of post-operative hospital stay.	1 week
Secondary	Postoperative pulmonary function recovery	To evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.	1 month