临床试验/NCT06727578

NCT06727578招募中不适用

A Pilot Assessment of the Safety and Efficacy of Pleural Irrigation for Retained Pleural Infection Using a Novel Irrigation Device

Beth Israel Deaconess Medical Center2 个研究点分布在 1 个国家目标入组 10 人开始时间: 2025年5月25日最近更新: 2026年8月27日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Beth Israel Deaconess Medical Center
入组人数: 10
试验地点: 2
主要终点: Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Single-arm pilot trial of the use of intrapleural saline irrigation to treat retained pleural infections for patients with contraindications to standard of care intrapleural enzymatic therapy.

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: 否

入选标准

•Retained pleural effusion identified via bedside ultrasound within the first 24 hours after chest tube insertion
•Patient is contraindicated from receiving intrapleural enzymatic therapy within the first 24 hours after chest tube insertion

排除标准

•Non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy)
•Post-procedural empyema or complicated parapneumonic effusion

结局指标

主要结局

Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.

时间窗: Daily for 8 days

次要结局

未报告次要终点

研究者

发起方

Beth Israel Deaconess Medical Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Adnan Majid, MD

Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,

Beth Israel Deaconess Medical Center

研究点 (2)

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