Clinical trial NCT02896595: General Anesthesia With ETT vs LMA in Patients Undergoing Ablation for Atrial Fibrillation
Official title: General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Procedure Time (Minutes)
timeFrame: Up to 270 minutes
Secondary outcomes:
measure: Fluoroscopy Time
timeFrame: Up to 270 minutes
measure: Total Anesthesia Time
timeFrame: Up to 270 minutes
measure: Time to Discharge From PACU
timeFrame: Up to 7 days
measure: Total Intra-procedure Opioids
timeFrame: Up to 270 minutes
measure: Anesthetic Requirements
timeFrame: Up to 270 minutes
measure: Anesthetic Requirements
timeFrame: Up to 270 minutes
measure: Intraoperative Hemodynamics
timeFrame: Up to 270 minutes
measure: Intraoperative Hemodynamics
timeFrame: Up to 270 minutes
measure: Intraoperative Hemodynamics
timeFrame: Up to 270 minutes
measure: Intraoperative Hemodynamics
timeFrame: Up to 270 minutes
measure: Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
timeFrame: Up to 270 minutes
measure: Electrophysiology Parameters
timeFrame: Up to 270 minutes
measure: Electrophysiology Parameters
timeFrame: Up to 270 minutes
measure: Electrophysiology Parameters
timeFrame: Up to 270 minutes
measure: Airway Trauma
timeFrame: Up to 7 days
measure: Post-procedure Nausea
timeFrame: Up to 7 days
measure: Post-procedure Emesis
timeFrame: Up to 7 days
measure: Atrial Fibrillation Recurrence
timeFrame: From end of procedure to six month followup holter monitor
measure: Aspiration Events
timeFrame: Up to 7 days
measure: Patient Satisfaction
timeFrame: Up to six months
measure: Cost Analysis
timeFrame: Up to six months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Praveen Prasanna, MD
role: PRINCIPAL_INVESTIGATOR
References: