GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GRAWITAS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- The overall procedural chest pain questionnaire
研究概览
简要总结
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure.
This study is a multicenter, single-blinded, randomized controlled trial designed to compare chest discomfort between gravity-driven and wall suction-driven therapeutic thoracentesis. Patients will be stratified by study centers, and randomly assigned to intervention and control arms; and will remain blinding to their group assignment during the procedure.
详细描述
Aims and Objectives:
The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure.
Expected Outcomes:
We anticipate that gravity driven therapeutic thoracentesis will result in improved clinical outcomes compared to wall suction driven thoracentesis, defined by less chest discomfort throughout the procedure as measured at 5 minutes post-procedure (primary endpoint).
Primary endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Referral to pulmonary services for large-volume thoracentesis
- •Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
- •Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR
- •CT-scan: maximum AP depth of the effusion ≥ 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR Ultrasound: effusion spanning at least three interspaces, with depth of 3 cm or greater in at least one intercostal space, while the patient sits upright.
- •Age >/= 18
排除标准
- •Inability to provide informed consent
- •Study subject has any disease or condition that interferes with safe completion of the study including:
- •Coagulopathy, with criteria left at the discretion of the operator
- •Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians
- •Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
- •Referral is for diagnostic thoracentesis only
- •Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound
- •Inability to sit for the procedure
结局指标
主要结局
The overall procedural chest pain questionnaire
时间窗: through study completion, an average of 1 year
The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment
次要结局
未报告次要终点