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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: General Anesthesia with laryngeal mask airway; Device: General Anesthesia with endotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02896595

HM20007902

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

General Anesthesia with endotracheal tube

Active Comparator group

Description:

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.

Treatment:

Device: General Anesthesia with endotracheal tube

General Anesthesia with laryngeal mask airway

Active Comparator group

Description:

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.

Treatment:

Device: General Anesthesia with laryngeal mask airway