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临床试验/NCT02896595
NCT02896595已完成不适用

General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Procedure Time (Minutes)

研究概览

简要总结

In recent years it has been shown that catheter ablation of symptomatic atrial fibrillation (PAF) is superior to antiarrhythmic drug therapy with regards to effectiveness and clinical outcomes. Atrial fibrillation is the most common cardiac arrhythmia, with high rates of concomitant heart failure, stroke and mortality. During an ablation procedure, a patient can be managed with intravenous sedation or General Anesthesia (GA). Within this setting, General anesthesia is associated with improved procedure time and cure rate compared to sedation.

Airway management during GA can be achieved through a laryngeal mask airway (LMA) or an endotracheal tube (ETT). The use of LMA compared to ETT has been shown in different surgical populations to decrease procedure and recovery time, improve hemodynamic stability and reduce anesthetic requirements. It has also shown to decrease airway complications, and postoperative nausea/vomiting which are important factors that affect overall patient satisfaction.

Although general anesthesia in electrophysiology procedures is associated with a higher cure rate, there have been reports of increased airway trauma.Additionally, it is believed that volatile anesthetics may be associated with increased ventricular action potential duration as well as prolonged QT interval. The increased usage of opioids during general anesthesia is also thought to interfere with electrophysiology studies by affecting vagal tone.

At Virginia Commonwealth University (VCU) Health system, Anesthesiologists have been successfully using LMA (General Anesthesia) for ablation in PAF in eligible patients for over five years. The investigators plan to perform a retrospective review of all patients who underwent catheter ablation of PAF at Virginia Commonwealth University Health System from January 2014 - December 2015. The primary endpoint evaluated will be procedure time. Other data collected will include demographics, cardiac history, type of anesthesia, amount of intra-procedure opioids, time to discharge from post anesthesia care unit (PACU), total length of hospital stay, intra-procedure hemodynamics, intra-procedure ionotrope/chronotrope/pressor requirements. and atrial fibrillation recurrence at a 3 month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing primary ablation for paroxysmal atrial fibrillation
  • Able to obtain consent in English language

排除标准

  • Patients <18 years old
  • Patients undergoing ablation for arrhythmias other than paroxysmal atrial fibrillation
  • American Society of Anesthesiologist physical status of 4 or greater
  • Patients undergoing repeat ablation
  • Pregnancy
  • Prisoners
  • Patients unable to give their own consent
  • Patients having trans esophageal echo on the same day
  • Patients unable to give consent in English language
  • Patients will also be excluded if the attending anesthesiologist determines that they would not be suitable candidates for intubation with either method (ETT tube or LMA mask).
  • Patients with severe gastroesophageal reflux disease
  • Patients with high risk of aspiration

结局指标

主要结局

Procedure Time (Minutes)

时间窗: Up to 270 minutes

Will be measured as time from start of procedure to end of procedure, as recorded in minutes

次要结局

  • Intraprocedure Pressor/Ionotrope/Chronotrope Requirements(Up to 270 minutes)
  • Fluoroscopy Time(Up to 270 minutes)
  • Total Anesthesia Time(Up to 270 minutes)
  • Time to Discharge From PACU(Up to 7 days)
  • Total Intra-procedure Opioids(Up to 270 minutes)
  • Airway Trauma(Up to 7 days)
  • Post-procedure Emesis(Up to 7 days)
  • Atrial Fibrillation Recurrence(From end of procedure to six month followup holter monitor)
  • Post-procedure Nausea(Up to 7 days)
  • Aspiration Events(Up to 7 days)
  • Patient Satisfaction(Up to six months)
  • Cost Analysis(Up to six months)
  • Anesthetic Requirements(Up to 270 minutes)
  • Intraoperative Hemodynamics(Up to 270 minutes)
  • Electrophysiology Parameters(Up to 270 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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