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Improved Drainage Strategy for Patients With Lung Wedge Resection

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04207671
Enrollment
600
Registered
2019-12-23
Start date
2020-03-31
Completion date
2022-05-31
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drainage

Keywords

Tubeless, Wedge resection, Improved drainage strategy

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.

Interventions

PROCEDUREComplete omission of chest tube

No chest tube implacement

PROCEDUREImproved drainage strategy

A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove

Sponsors

Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence rate of massive pneumothorax on day 1 after surgery1 dayTo evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray)

Secondary

MeasureTime frameDescription
Pain score on day 1 after surgery1 dayTo 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 stay1 weekTo evaluate the length of post-operative hospital stay.
Postoperative pulmonary function recovery1 monthTo evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.

Contacts

Primary ContactJia-Tao Zhang, Ph.D
18820792959@163.com+86-83827812-51311
Backup ContactWen-Zhao Zhong, Ph.D
13609777314@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026