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

Atrial Fibrillation Clinical Trial

Official title:

General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896595
• Other study ID #: HM20007902
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: January 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 31, 2019
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fluoroscopy Time	As measured and reported by electrophysiology and radiology notes, recorded in minutes	Up to 270 minutes
Secondary	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
Secondary	Time to Discharge From PACU	time from arrival to PACU until discharge from anesthesia care	Up to 7 days
Secondary	Total Intra-procedure Opioids	Measured in mcg of Fentanyl	Up to 270 minutes
Secondary	Anesthetic Requirements	average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)	Up to 270 minutes
Secondary	Anesthetic Requirements	average amount of intravenous anesthetics	Up to 270 minutes
Secondary	Intraoperative Hemodynamics	heart rate (beats per minute)	Up to 270 minutes
Secondary	Intraoperative Hemodynamics	mean arterial pressure	Up to 270 minutes
Secondary	Intraoperative Hemodynamics	systolic blood pressure	Up to 270 minutes
Secondary	Intraoperative Hemodynamics	diastolic blood pressure	Up to 270 minutes
Secondary	Intraprocedure Pressor/Ionotrope/Chronotrope Requirements	total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively	Up to 270 minutes
Secondary	Electrophysiology Parameters	duration of paroxysmal atrial fibrillation prior to procedure	Up to 270 minutes
Secondary	Electrophysiology Parameters	size of left atrium (mm)	Up to 270 minutes
Secondary	Electrophysiology Parameters	left ventricular ejection fraction	Up to 270 minutes
Secondary	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
Secondary	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
Secondary	Post-procedure Emesis	Measured by number of times patient has emesis during post-procedure time period	Up to 7 days
Secondary	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
Secondary	Aspiration Events	aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented	Up to 7 days
Secondary	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
Secondary	Cost Analysis	an analysis of cost to patient as well as overall hospital costs will be conducted	Up to six months