跳至主要内容
临床试验/NCT07338019
NCT07338019招募中不适用

The Buzdar Technique for Pulmonary Parenchymal Chest Tube Removal: Prospective Evaluation of a Novel Minimally Invasive Protocol

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Complete chest tube removal

研究概览

简要总结

Chest tube thoracostomy remains a lifesaving intervention in trauma and thoracic surgery, used for the management of pneumothorax, hemothorax, empyema, and pleural effusions. Despite being one of the most frequently performed procedures worldwide, complication rates remain high, ranging from 20% to 40% [1]. Among these, pulmonary parenchymal chest tube (PPcT) insertion represents a rare but potentially devastating event, leading to hemorrhage, air leak, bronchopleural fistula, or infection. In Pakistan, where chest trauma and pneumothorax constitute major thoracic morbidities, PPcT cases are encountered with increasing frequency but remain underreported. Current literature describes only invasive surgical approaches-such as thoracotomy or video-assisted thoracic surgery (VATS)-for PPcT removal [9,10], with no established minimally invasive alternatives.

In response to this clinical challenge, the Department of Thoracic Surgery at (Hospital Name), Punjab, Pakistan, has developed and implemented a novel, minimally invasive three-stage removal technique, termed the Buzdar Technique, designed to ensure safe extraction of intraparenchymal chest tubes without surgical intervention. The technique follows a standardized protocol involving:

Healing phase: Tube left in situ for approximately two weeks to allow localized fibrosis and stabilization of the lung parenchyma.

Initial retraction: Gradual 2-cm withdrawal with optional 360° rotation under radiologic and clinical supervision, followed by 24-hour observation and chest imaging.

Sequential retractions: Weekly staged retractions of 2 cm until the last fenestration exits the pleural cavity, enabling safe final removal.

This prospective cohort study, conducted from July 2025 to June 2026, aims to evaluate the safety, effectiveness, and clinical outcomes of the Buzdar Technique in managing iatrogenic PPcT. Data will include patient demographics, procedural details, complications, radiologic recovery, and overall outcomes. Success will be defined as complete tube removal without pneumothorax, air leak, bleeding, or need for surgical intervention.

Preliminary institutional experience over the past decade has shown excellent results, with minimal morbidity, no requirement for thoracotomy or VATS, and full radiologic recovery in the majority of patients. The expected outcomes of this prospective evaluation are to validate these findings, establish the Buzdar Technique as a reproducible, evidence-based approach, and contribute to the global literature on non-surgical management of PPcT.

If proven effective, this technique could represent a paradigm shift in the management of intraparenchymal chest tubes-offering a safe, staged, and minimally invasive alternative to surgical removal, particularly beneficial for centers in low- and middle-income countries where advanced surgical options may not always be available.

详细描述

Chest tube thoracostomy remains a cornerstone in the management of pleural and thoracic pathologies, including pneumothorax, hemothorax, empyema, and pleural effusions. By lowering intrapleural pressure and promoting lung re-expansion, it ensures adequate tissue oxygenation and effective ventilation [1, 2]. Despite its widespread use, complication rates following tube thoracostomy remain high-ranging from 20% to 40%-and include insertional, positional, and infectious events. Pneumothorax and chest trauma are among the major causes of thoracic morbidity in Pakistan. In a Karachi-based study, 40% of 146 pneumothorax cases were attributed to traumatic and iatrogenic causes, with intercostal tube drainage utilized in 81% of patients. Similarly, another study reported that 35% of thoracic trauma patients experienced tube-related complications such as empyema and bronchopleural fistula. These findings underscore the urgent need for procedural standardization, improved operator training, and enhanced complication management strategies.

Tube thoracostomy is a frequently performed procedure in emergency and trauma care settings, taught in most surgical and medical training curricula and standardized within the Advanced Trauma Life Support (ATLS) program. Nevertheless, globally, insertion-related complications continue to present significant clinical challenges. International literature has emphasized the importance of standardized classification and reporting systems for chest tube-related complications, broadly categorizing them into insertional, positional, removal, infectious, and device-related events. The implementation of such standardized systems and adherence to best-practice protocols have been shown to reduce complication rates significantly-from 12.6% to as low as 4.4% in some trauma centers.

Among insertional complications, pulmonary parenchymal chest tube (PPcT) represents one of the most serious, occurring when the chest tube inadvertently traverses into the lung tissue. PPcT is particularly associated with patients who have pleural adhesions, poor pulmonary compliance, or consolidated lungs. Despite its potential to cause catastrophic outcomes such as bleeding or bronchopleural fistula, PPcT remains underreported and lacks standardized management guidelines. Reported interventions for removal are limited to invasive surgical approaches such as thoracotomy with thoracoplasty and video-assisted thoracic surgery (VATS) without lung resection. However, no literature currently describes minimally invasive, staged, or gradual removal techniques for such cases.

At the Department of Thoracic Surgery, Services Hospital, Lahore, Punjab, Pakistan, several cases of PPcT have been managed over the last decade. In response to this clinical challenge, our team developed a novel, minimally invasive three-stage removal strategy, termed the Buzdar Technique, initiated in 2006. This standardized protocol aims to achieve safe removal of intraparenchymal chest tubes without the need for thoracotomy or VATS while minimizing morbidity and preventing recurrence or pneumothorax. The method involves: (1) leaving the tube in situ for approximately two weeks to promote localized fibrosis; (2) gradual 2-cm retractions with optional 360° rotation under radiologic and clinical monitoring, followed by a 24-hour observation and chest radiograph; and (3) sequential weekly retractions until the last fenestration exits the pleural space, at which point safe removal is achieved.

This prospective cohort study, conducted from July 2025 to June 2026, aims to evaluate the effectiveness, safety, and clinical outcomes of the Buzdar Technique for managing pulmonary parenchymal chest tubes. By documenting its results systematically, this study seeks to provide evidence for a reproducible, less invasive alternative to surgical extraction, potentially establishing a new standard of care in managing PPcT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥18 years with confirmed intraparenchymal chest tube placement on chest CT or X-ray.
  • Hemodynamically stable patients suitable for conservative staged removal.
  • Patients providing informed consent.

排除标准

  • Patients requiring immediate thoracotomy due to massive bleeding or large bronchopleural fistula.
  • Patients with uncorrectable coagulopathy or unstable cardiopulmonary status.
  • Patients refusing participation or lost to follow-up.

研究组 & 干预措施

Pulmonary Parenchymal Tube Group

Experimental

The Buzdar Technique is a standardized, three-stage, minimally invasive approach designed to safely remove intraparenchymal chest tubes without thoracotomy or VATS. It aims to promote controlled fibrosis and gradual parenchymal healing before complete tube withdrawal.

干预措施: Gradual chest tube removal (Procedure)

结局指标

主要结局

Complete chest tube removal

时间窗: 02 weeks

Successful removal of the Pulmonary Parenchymal chest Tube without pneumothorax, significant air leak, or bleeding.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeeshan Sarwar

Doctor

University of Health Sciences Lahore

研究点 (1)

Loading locations...

相似试验