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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
General Anesthesia with endotracheal tube
General Anesthesia with laryngeal mask airway
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General Anesthesia with endotracheal tube

General Anesthesia with laryngeal mask airway

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fluoroscopy Time
As measured and reported by electrophysiology and radiology notes, recorded in minutes
Total Anesthesia Time
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
time from arrival to PACU until discharge from anesthesia care
Total Intra-procedure Opioids
Measured in mcg of Fentanyl
Anesthetic Requirements
average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)
Anesthetic Requirements
average amount of intravenous anesthetics
Intraoperative Hemodynamics
heart rate (beats per minute)
Intraoperative Hemodynamics
mean arterial pressure
Intraoperative Hemodynamics
systolic blood pressure
Intraoperative Hemodynamics
diastolic blood pressure
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
Electrophysiology Parameters
duration of paroxysmal atrial fibrillation prior to procedure
Electrophysiology Parameters
size of left atrium (mm)
Electrophysiology Parameters
left ventricular ejection fraction
Airway Trauma
Any noted trauma in the anesthesia or post-procedure notes, including damage to lips/teeth, laryngospasm, need for reintubation post procedure
Post-procedure Nausea
Measured by number of doses of antiemetics given in the post-procedure time period mg of Zofran (ondanesteron) given post-operatively
Post-procedure Emesis
Measured by number of times patient has emesis during post-procedure time period
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
Aspiration Events
aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
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
Cost Analysis
an analysis of cost to patient as well as overall hospital costs will be conducted

Full Information

First Posted
August 29, 2016
Last Updated
January 9, 2020
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02896595
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Anesthesia with endotracheal tube
Arm Type
Active Comparator
Arm 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.
Arm Title
General Anesthesia with laryngeal mask airway
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
General Anesthesia with endotracheal tube
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
General Anesthesia with laryngeal mask airway
Intervention Description
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 Outcome Measure Information:
Title
Procedure Time (Minutes)
Description
Will be measured as time from start of procedure to end of procedure, as recorded in minutes
Time Frame
Up to 270 minutes
Secondary Outcome Measure Information:
Title
Fluoroscopy Time
Description
As measured and reported by electrophysiology and radiology notes, recorded in minutes
Time Frame
Up to 270 minutes
Title
Total Anesthesia Time
Description
Total anesthesia time as measured in minutes and recorded in the anesthesia record, from anesthesia start time to anesthesia stop time
Time Frame
Up to 270 minutes
Title
Time to Discharge From PACU
Description
time from arrival to PACU until discharge from anesthesia care
Time Frame
Up to 7 days
Title
Total Intra-procedure Opioids
Description
Measured in mcg of Fentanyl
Time Frame
Up to 270 minutes
Title
Anesthetic Requirements
Description
average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)
Time Frame
Up to 270 minutes
Title
Anesthetic Requirements
Description
average amount of intravenous anesthetics
Time Frame
Up to 270 minutes
Title
Intraoperative Hemodynamics
Description
heart rate (beats per minute)
Time Frame
Up to 270 minutes
Title
Intraoperative Hemodynamics
Description
mean arterial pressure
Time Frame
Up to 270 minutes
Title
Intraoperative Hemodynamics
Description
systolic blood pressure
Time Frame
Up to 270 minutes
Title
Intraoperative Hemodynamics
Description
diastolic blood pressure
Time Frame
Up to 270 minutes
Title
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
Description
total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
Time Frame
Up to 270 minutes
Title
Electrophysiology Parameters
Description
duration of paroxysmal atrial fibrillation prior to procedure
Time Frame
Up to 270 minutes
Title
Electrophysiology Parameters
Description
size of left atrium (mm)
Time Frame
Up to 270 minutes
Title
Electrophysiology Parameters
Description
left ventricular ejection fraction
Time Frame
Up to 270 minutes
Title
Airway Trauma
Description
Any noted trauma in the anesthesia or post-procedure notes, including damage to lips/teeth, laryngospasm, need for reintubation post procedure
Time Frame
Up to 7 days
Title
Post-procedure Nausea
Description
Measured by number of doses of antiemetics given in the post-procedure time period mg of Zofran (ondanesteron) given post-operatively
Time Frame
Up to 7 days
Title
Post-procedure Emesis
Description
Measured by number of times patient has emesis during post-procedure time period
Time Frame
Up to 7 days
Title
Atrial Fibrillation Recurrence
Description
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
Time Frame
From end of procedure to six month followup holter monitor
Title
Aspiration Events
Description
aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
Time Frame
Up to 7 days
Title
Patient Satisfaction
Description
patients will be given an survey by study personnel prior to discharge from the hospital; survey will be conducted in person by study personnel
Time Frame
Up to six months
Title
Cost Analysis
Description
an analysis of cost to patient as well as overall hospital costs will be conducted
Time Frame
Up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Praveen Prasanna, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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