跳至主要内容
临床试验/NCT03591952
NCT03591952已完成不适用

Gravity- Versus Suction-driven Large Volume Thoracentesis: a Randomized Controlled Study

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
1
主要终点
Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups

研究概览

简要总结

Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. While most proceduralists use suction to drain the pleural fluid, some drain effusions by gravity only. The investigators propose to evaluate whether gravity-driven thoracentesis results in less discomfort for patients than suction-drive thoracentesis.

详细描述

Therapeutic thoracentesis aims to drain fluid from the pleural space to alleviate breathlessness. The amount of and speed with which the fluid can be safely drained in one setting is unclear, and likely depends on the physiology of the pleural effusion. The principle concern when draining a large amount of fluid quickly from the pleural space is that excessively negative pleural pressure may be generated; this occurs if the lung is unable to freely re-expand into the space previously occupied by fluid. Excessively negative pleural pressure and the resulting high transpulmonary pressure gradient are thought to be associated with several complications, including pneumothorax ex vacuo, chest discomfort, and re-expansion pulmonary edema (REPE). Evidence suggests that monitoring pleural pressures during thoracentesis via manometry does not mitigate this problem. In fact, data shows that whether manometry is used or not, most patients do experience clinically significant increase in chest discomfort during thoracentesis. Current methods for draining the pleural fluid include suction- (via vacuum bottles, wall suction or the use of large syringes with a one-way valve tubing system) or gravity-driven thoracentesis. Pressures generated by all suction techniques range from -200 to -500 cmH2O, and far exceed what are considered safe pleural pressures. Accordingly, in case of non-expandable lung, excessively negative pressures may develop quickly, exposing patients to complications. Some clinicians advocate for gravity drainage, which generates less negative pressures in the pleural space (specifically defined as the vertical distance between the catheter and the drainage bag, generally around -50 to -100 cmH20). While this technique is considered standard of care by some as it is potentially more comfortable for patients, it is also likely associated with longer procedures, and is not generally favored by clinicians who in general prefer suction drainage, despite the possible higher risk of complications.The investigators propose to study the impact of gravity- versus suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure, and consider as secondary endpoints: the duration of the procedure, the amount of pleural fluid drained, the rate of REPE, the rate of pneumothorax ex vacuo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Subjects will be randomly allocated into intervention (gravity-driven) and control (suction-driven) groups by opening an opaque study envelope just prior to starting the procedure containing group assignment. Participants will be blinded to the use of gravity VS. suction drainage to prevent knowledge of their group assignment from biasing their pain assessments.

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 interspace, while the patient sits upright.

排除标准

  • •Inability to provide informed consent
  • •Patient has already been enrolled in this study
  • •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 on bedside pre-procedure ultrasound
  • •Inability to sit for the procedure

研究组 & 干预措施

Suction

Active Comparator

The pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care.

干预措施: Suction-Driven Thoracentesis (Procedure)

Gravity

Experimental

The pleural fluid will be drained using gravity drainage to a bag positioned approximately 100 cm (approximately 40 inches) below the catheter entry point (see picture below) using the 40 inch tubing provided in the thoracentesis kit (CareFusion or Arrow).

干预措施: Gravity-Driven Thoracentesis (Procedure)

结局指标

主要结局

Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups

时间窗: One-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)

As measured in millimeters along a 10 cm Visual Analog Scale (VAS). The estimated minimal clinically important difference is 15 mm. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention versus (vs) control, will be made using the t-test or Wilcoxon Rank Sum test. Mixed model will be employed to assess the trend of pain score measured across pre-, intra-, and post-procedure.

次要结局

  • Incidence of clinically-significant re-expansion pulmonary edema(20 minutes after thoracentesis catheter is removed (on day 1))
  • Incidence of pneumothorax(20 minutes after thoracentesis catheter is removed (on day 1))
  • Volume of pleural fluid removed by the thoracentesis procedure(Immediately after the thoracentesis catheter is removed, on day 1)
  • Duration of procedure(During the procedure, on day 1, intraoperative)
  • Incidence of radiographically-apparent re-expansion pulmonary edema(20 minutes after thoracentesis catheter is removed (on day 1))
  • Improvement in dyspnea scores(From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1))

研究者

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

Fabien Maldonado

Associate Professor of Allergy/Pulmonary & Critical Care Medicine

Vanderbilt University Medical Center

研究点 (1)

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