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Clinical Trials/NCT03230019
NCT03230019
Unknown
Not Applicable

Two-Lumen Catheterization Versus Chest Tube Placement in Patients With Lung Wedge Resection: A Prospective Randomized Trial

Wen-zhao ZHONG1 site in 1 country96 target enrollmentAugust 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Surgery, Video-Assisted
Sponsor
Wen-zhao ZHONG
Enrollment
96
Locations
1
Primary Endpoint
Postoperative adverse event incidence rate
Last Updated
7 years ago

Overview

Brief Summary

This study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection. Half of participants will receive routine chest tube placement, 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\~40% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization for remedial gas-remove. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus chest tube placement in patients with lung wedge resection.

Registry
clinicaltrials.gov
Start Date
August 25, 2017
End Date
October 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wen-zhao ZHONG
Responsible Party
Sponsor Investigator
Principal Investigator

Wen-zhao ZHONG

Guangdong General Hospital

Guangdong Provincial People's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative adverse event incidence rate

Time Frame: 1 months

To evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (\>800ml) in both groups.

Rate of post-operative related complications

Time Frame: 1 week

To evaluate the rate of post-operative related complications within 7 days of surgery

Length of post-operative hospital stay

Time Frame: 1 week

To evaluate the length of post-operative hospital stay

Secondary Outcomes

  • The time of post-operative extubation(1 week)
  • Postoperative pulmonary function recovery(1 week)
  • Postoperative wound satisfaction(1 month)
  • Postoperative pneumoderm incidence rate(3 days)
  • Postoperative pain score(1 day)

Study Sites (1)

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