Comparing Active Versus Passive Aspiration in Therapeutic Thoracentesis: Efficacy, Procedure Time, and Patient Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Volume of Fluid Aspirated
研究概览
简要总结
This single-blind randomized controlled trial (RCT) aims to compare the efficacy and safety of active manual aspiration versus passive gravity drainage during therapeutic thoracentesis for large symptomatic pleural effusions. A total of 60 eligible patients will be randomized into two equal groups. The active aspiration group will undergo fluid removal using manual syringe suction, while the passive aspiration group will undergo drainage via gravity. The primary outcomes of the study are the total procedure time and the volume of pleural fluid aspirated. Secondary outcomes include patient-reported pain (measured on a Numeric Rating Scale), patient-reported dyspnea (measured by the mMRC scale), the incidence of procedure-related cough, and the reason for procedure termination. The goal of this study is to determine which technique offers a better balance of efficiency and patient comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Patients of either gender.
- •Aged above 18 years.
- •With symptomatic large pleural effusion (either exudative or transudative).
- •Requiring therapeutic pleurocentesis.
- •Modified Medical Research Council (mMRC) dyspnea scale grade 3-4.
排除标准
- •Uncorrected bleeding diathesis.
- •Chest wall cellulitis at the intended site of puncture.
- •Uncooperative patients.
- •Loculated pleural effusion.
- •Traumatic hemothorax.
- •Empyema thoracis.
- •Hydropneumothorax.
- •Patients who refused to participate.
结局指标
主要结局
Volume of Fluid Aspirated
时间窗: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
The total volume of pleural fluid successfully removed during the procedure, measured in milliliters (ml).
Procedure Time for Therapeutic Thoracentesis
时间窗: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
The total duration of the thoracentesis procedure, measured in minutes, from the initial needle insertion until the procedure was terminated. Termination occurred when no more fluid could be drained, the target volume was reached, or due to patient complications like cough or discomfort.
次要结局
- Patient-Reported Pain(Immediately upon procedure completion (at the time of needle removal) and fluid extraction.)
- Patient-Reported Dyspnea(Immediately upon procedure completion (at the time of needle removal) and fluid extraction.)
- Incidence of Cough(Immediately upon procedure completion (at the time of needle removal) and fluid extraction.)
研究者
Talha Mahmud
Professor Dr. Talha Mahmud
Sheikh Zayed Federal Postgraduate Medical Institute