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OpenTrials
Completed

NCT Number: NCT02896595

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General Anesthesia with endotracheal tube

Device

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

Device

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.

Primary outcomes

  1. Procedure Time (Minutes)

    Time frame: Up to 270 minutes

    Will be measured as time from start of procedure to end of procedure, as recorded in minutes

Secondary outcomes

  1. Fluoroscopy Time

    Time frame: Up to 270 minutes

    As measured and reported by electrophysiology and radiology notes, recorded in minutes

  2. Total Anesthesia Time

    Time frame: 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

  3. Time to Discharge From PACU

    Time frame: Up to 7 days

    time from arrival to PACU until discharge from anesthesia care

  4. Total Intra-procedure Opioids

    Time frame: Up to 270 minutes

    Measured in mcg of Fentanyl

  5. Anesthetic Requirements

    Time frame: Up to 270 minutes

    average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)

  6. Anesthetic Requirements

    Time frame: Up to 270 minutes

    average amount of intravenous anesthetics

  7. Intraoperative Hemodynamics

    Time frame: Up to 270 minutes

    heart rate (beats per minute)

  8. Intraoperative Hemodynamics

    Time frame: Up to 270 minutes

    mean arterial pressure

  9. Intraoperative Hemodynamics

    Time frame: Up to 270 minutes

    systolic blood pressure

  10. Intraoperative Hemodynamics

    Time frame: Up to 270 minutes

    diastolic blood pressure

  11. Intraprocedure Pressor/Ionotrope/Chronotrope Requirements

    Time frame: Up to 270 minutes

    total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively

  12. Electrophysiology Parameters

    Time frame: Up to 270 minutes

    duration of paroxysmal atrial fibrillation prior to procedure

  13. Electrophysiology Parameters

    Time frame: Up to 270 minutes

    size of left atrium (mm)

  14. Electrophysiology Parameters

    Time frame: Up to 270 minutes

    left ventricular ejection fraction

  15. Airway Trauma

    Time frame: 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

  16. Post-procedure Nausea

    Time frame: 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

  17. Post-procedure Emesis

    Time frame: Up to 7 days

    Measured by number of times patient has emesis during post-procedure time period

  18. Atrial Fibrillation Recurrence

    Time frame: 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

  19. Aspiration Events

    Time frame: Up to 7 days

    aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented

  20. Patient Satisfaction

    Time frame: 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

  21. Cost Analysis

    Time frame: Up to six months

    an analysis of cost to patient as well as overall hospital costs will be conducted

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 12, 2016
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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