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Two-Lumen Catheterization For Lung Wedge Resection

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03230019
Enrollment
96
Registered
2017-07-26
Start date
2017-08-25
Completion date
2019-10-30
Last updated
2018-11-14

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

Conditions

Thoracic Surgery, Video-Assisted

Keywords

wedge resection, tubeless

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.

Interventions

PROCEDUREchest tube

VATS with chest tube placement

PROCEDUREtwo-lumen catheterization

VATS with two-lumen catheterization long the midclavicular line, second intercostal space

DEVICEtwo-lumen catheter

central venous catheter(two-lumen 7-Fr-20cm)

Sponsors

Guangdong Provincial People's Hospital
CollaboratorOTHER
Wen-zhao ZHONG
Lead SponsorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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
Rate of post-operative related complications1 weekTo evaluate the rate of post-operative related complications within 7 days of surgery
Postoperative adverse event incidence rate1 monthsTo evaluate the incidence rate of pneumothorax (a pneumothorax greater than 2.0 cm on X-ray) or pleural effusion (\>800ml) in both groups.
Length of post-operative hospital stay1 weekTo evaluate the length of post-operative hospital stay

Secondary

MeasureTime frameDescription
Postoperative pulmonary function recovery1 weekTo evaluate the postoperative cardiopulmonary function recovery via 6-minute walk test in both groups.
Postoperative wound satisfaction1 monthTo evaluate the post-operative wound healing condition .
Postoperative pain score1 dayTo evaluate the pain score via NRS pain scale first day after surgery.
Postoperative pneumoderm incidence rate3 daysTo evaluate the postoperative pneumoderm incidence rate in both groups.
The time of post-operative extubation1 weekTo evaluate the time of duration of chest tube or catheterization.

Other

MeasureTime frameDescription
Characteristics of plasma exosome for the solitary pulmonary nodules1 monthWe prospectively collect the preoperative plasma sample of patients with solitary pulmonary nodule in this study to determine the diagnostic value and molecular characteristics of plasma exosome-derived miRNAs for these patients.

Countries

China

Contacts

Primary ContactWen-Zhao Zhong
18820792959@163.com18820792959
Backup ContactSong Dong
dsong@aliyun.com13631381979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026