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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: General Anesthesia with endotracheal tube
* Device: General Anesthesia with laryngeal mask airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia with endotracheal tube<br>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. | Device: General Anesthesia with endotracheal tube<br>* 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.<br>|
| Active Comparator: General Anesthesia with laryngeal mask airway<br>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. | Device: General Anesthesia with laryngeal mask airway<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Time (Minutes) | Will be measured as time from start of procedure to end of procedure, as recorded in minutes | Up to 270 minutes | 

Secondary Outcome Measures

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