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临床试验/NCT03635034
NCT03635034已完成不适用

Examining the Routine Use of Bladder Catheters During Atrial Fibrillation Procedures

St. Vincent Cardiovascular Research Institute2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
Composite of catheter associated complications at day one and thirty will be assessed among the two arms - those with bladder catheters and those who did not receive the bladder catheter during the ablation procedure.

研究概览

简要总结

Inserting a Bladder catheter during catheter ablation is standard practice at most Institutions. Unfortunately, bladder catheters are associated with adverse outcomes, including catheter associated cystitis, hematuria, dysuria, and urethral damage.

The investigator proposes a prospective, randomized clinical trial comparing group A that will receive a catheter during the ablation procedure and group B that will not receive the procedure. The Investigator hypothesizes the group receiving the bladder catheters will have a higher rate of complications.

详细描述

(AF) is the commonest arrhythmia worldwide and accounts for significant morbidity. The mainstay of treatment for drug refractory AF is catheter ablation. A preponderance of evidence indicates better outcomes when this procedure is performed under general anesthesia; this is standard of care at our institution. However, for a variety of reasons including long procedure time, procedural intravenous fluid administration, and prolonged bedrest following the procedure, standard of care at our institution and others is for bladder catheter placement during the procedure (4). Unfortunately, bladder catheters used during cardiac surgery have been associated with adverse outcomes, including catheter associated cystitis, hematuria, dysuria, and urethral damage(

Fortunately, the landscape of AF ablation is changing rapidly, and procedure times are rapidly decreasing. Improvements in three dimensional mapping technology has allowed for less reliance on fluoroscopy and allows for real time visualization of ablation lesions. Improvements in ablation catheters have allowed for significantly reduced intravenous fluid administration during the procedure. The Site has also adopted an expedited protocol for venous hemostasis following the procedure that involves a figure-of-eight groin stitch, allowing for earlier mobility and a shorter bed rest following the procedure. Therefore, we question the need for routine bladder catheter placement during AF ablation procedures

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • All subjects presenting to the St. Vincent EP lab for AF ablation Ability to sign informed consent

排除标准

  • Recent (within 1 month) cystitis, history of urinary retention or incontinence, prior bladder catheter associated complications, hematuria, chronic kidney disease (stage II, III, IV, or V), dialysis, prostate cancer, renal cancer, bladder cancer, expected procedure duration >6 hours.

结局指标

主要结局

Composite of catheter associated complications at day one and thirty will be assessed among the two arms - those with bladder catheters and those who did not receive the bladder catheter during the ablation procedure.

时间窗: Post-op day 1 and 30 days

Per patient reported outcomes, subjects will be asked if they experienced any of the following complications: cystitis, hematuria, dysuria, urethral damage and urinary retention. The primary composite outcome of cystitis, hematuria, dysuria, urethral damage or urinary retention will be compared using Chisq or Fisher's exact test. Additional bivariate correlates to the primary outcome will be analysed including age, gender, operator, procedure satisfaction score, procedure duration, procedural fluid administration, total hospital stay fluid administration, and baseline clinical variables. Variables with p value \<o.o5 on bivariate analysis will be included in a multivariate regression model.

次要结局

未报告次要终点

研究者

发起方
St. Vincent Cardiovascular Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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