General Anesthesia With ETT vs LMA in Patients Undergoing Ablation for Atrial Fibrillation

Overview

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.

Full Title of Study: “General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Health Services Research
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: December 11, 2018

Interventions

• 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.

Arms, Groups and Cohorts

• Active Comparator: General Anesthesia with endotracheal tube
  • Patients assigned to the ETT tube group will have ETT placed in the safest manner deemed appropriate by attending anesthesiologist. Possible ways to have ETT placed will be using direct laryngoscopy, glidescope or fiberoptic intubations. Size of ETT will be decided based on patient characteristics and discretion of attending anesthesiologist. Once placed, auscultation and capnography will be used to ensure correct placement of ETT.
• Active Comparator: General Anesthesia with laryngeal mask airway
  • Patients assigned to the LMA group will have LMA placed in a standard fashion by anesthesia provider. LMA size will be decided based on patient characteristics and at the discretion of attending anesthesiologist. LMA used will be LMA Supreme (Teleflex Medicals, Ireland). Once placed auscultation will be used to ensure correct placement of LMA.

Clinical Trial Outcome Measures

Primary Measures

• Procedure Time (Minutes)
  • Time Frame: Up to 270 minutes
  • Will be measured as time from start of procedure to end of procedure, as recorded in minutes

Secondary Measures

• Fluoroscopy Time
  • Time Frame: Up to 270 minutes
  • As measured and reported by electrophysiology and radiology notes, recorded in minutes
• Total Anesthesia Time
  • Time Frame: Up to 270 minutes
  • Total anesthesia time as measured in minutes and recorded in the anesthesia record, from anesthesia start time to anesthesia stop time
• Time to Discharge From PACU
  • Time Frame: Up to 7 days
  • time from arrival to PACU until discharge from anesthesia care
• Total Intra-procedure Opioids
  • Time Frame: Up to 270 minutes
  • Measured in mcg of Fentanyl
• Anesthetic Requirements
  • Time Frame: Up to 270 minutes
  • average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)
• Anesthetic Requirements
  • Time Frame: Up to 270 minutes
  • average amount of intravenous anesthetics
• Intraoperative Hemodynamics
  • Time Frame: Up to 270 minutes
  • heart rate (beats per minute)
• Intraoperative Hemodynamics
  • Time Frame: Up to 270 minutes
  • mean arterial pressure
• Intraoperative Hemodynamics
  • Time Frame: Up to 270 minutes
  • systolic blood pressure
• Intraoperative Hemodynamics
  • Time Frame: Up to 270 minutes
  • diastolic blood pressure
• Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
  • Time Frame: Up to 270 minutes
  • total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
• Electrophysiology Parameters
  • Time Frame: Up to 270 minutes
  • duration of paroxysmal atrial fibrillation prior to procedure
• Electrophysiology Parameters
  • Time Frame: Up to 270 minutes
  • size of left atrium (mm)
• Electrophysiology Parameters
  • Time Frame: Up to 270 minutes
  • left ventricular ejection fraction
• Airway Trauma
  • Time Frame: Up to 7 days
  • Any noted trauma in the anesthesia or post-procedure notes, including damage to lips/teeth, laryngospasm, need for reintubation post procedure
• Post-procedure Nausea
  • Time Frame: Up to 7 days
  • Measured by number of doses of antiemetics given in the post-procedure time period mg of Zofran (ondanesteron) given post-operatively
• Post-procedure Emesis
  • Time Frame: Up to 7 days
  • Measured by number of times patient has emesis during post-procedure time period
• Atrial Fibrillation Recurrence
  • Time Frame: From end of procedure to six month followup holter monitor
  • defined as recurrence of paroxysmal atrial fibrillation recurring at any time after 6 weeks past the day of procedure. As standard of care these patients are followed up with Holter monitoring for a period of 6 months. Holter monitoring will be done for 48 hour time periods immediately post-procedure, 2 weeks, 6 weeks, 4 months and 6 months post procedure as is standard of care
• Aspiration Events
  • Time Frame: Up to 7 days
  • aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
• Patient Satisfaction
  • Time Frame: Up to six months
  • patients will be given an survey by study personnel prior to discharge from the hospital; survey will be conducted in person by study personnel
• Cost Analysis
  • Time Frame: Up to six months
  • an analysis of cost to patient as well as overall hospital costs will be conducted

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Virginia Commonwealth University
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Praveen Prasanna, MD, Principal Investigator, Virginia Commonwealth University