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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: General Anesthesia with laryngeal mask airway; Device: General Anesthesia with endotracheal tube

• Registration Number: NCT02896595
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-29
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2018-12-11
• Study Completion: 2019-01-31
• Results First Submitted: 2019-12-13
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-09
• Results First Posted: 2020-01-21
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing primary ablation for paroxysmal atrial fibrillation
• Able to obtain consent in English language
• BMI <35

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia with laryngeal mask airway	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.
General Anesthesia with endotracheal tube	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Airway Trauma	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 Emesis	Up to 7 days	Measured by number of times patient has emesis during post-procedure time period
Intraoperative Hemodynamics	Up to 270 minutes	diastolic blood pressure
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements	Up to 270 minutes	total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
Fluoroscopy Time	Up to 270 minutes	As measured and reported by electrophysiology and radiology notes, recorded in minutes
Total Anesthesia Time	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	Up to 7 days	time from arrival to PACU until discharge from anesthesia care
Total Intra-procedure Opioids	Up to 270 minutes	Measured in mcg of Fentanyl
Anesthetic Requirements	Up to 270 minutes	average amount of intravenous anesthetics
Electrophysiology Parameters	Up to 270 minutes	left ventricular ejection fraction
Atrial Fibrillation Recurrence	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
Cost Analysis	Up to six months	an analysis of cost to patient as well as overall hospital costs will be conducted
Post-procedure Nausea	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
Aspiration Events	Up to 7 days	aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
Patient Satisfaction	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States