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General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial (NCT02896595)

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 Commonwelath 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.
  • Device: General Anesthesia with endotracheal tube
    Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs.
    • Device: General Anesthesia with laryngeal mask airway
      Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs.
      Ages eligible for Study
      18 Years to 99 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Patients undergoing primary ablation for paroxysmal atrial fibrillation
      • Able to obtain consent in English language
      • BMI <35
      Exclusion Criteria:
      • 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
      • BMI >35
      • 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

      1 locations

      United States (1)
      • Virginia Commonwealth University
        recruiting
        Richmond, Virginia, United States, 23298
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 August, 2016
      Updated:
      04 January, 2017
      Participants:
      96
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