Atrial Fibrillation
Conditions
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.
Interventions
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.
DEVICEGeneral 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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 end tidal volatile anesthetics Measured as intra operative anesthetic (MAC) |
| Intraoperative Hemodynamics | Up to 270 minutes | heart rate (beats per minute) |
| Intraprocedure Pressor/Ionotrope/Chronotrope Requirements | Up to 270 minutes | total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively |
| Electrophysiology Parameters | Up to 270 minutes | duration of paroxysmal atrial fibrillation prior to procedure |
| Fluoroscopy Time | Up to 270 minutes | As measured and reported by electrophysiology and radiology notes, recorded in minutes |
| 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 |
| Post-procedure Emesis | Up to 7 days | Measured by number of times patient has emesis during post-procedure time period |
| 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 |
| 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 |
| Cost Analysis | Up to six months | an analysis of cost to patient as well as overall hospital costs will be conducted |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 50 |
| 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 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | General Anesthesia With Endotracheal Tube | Total | General Anesthesia With Laryngeal Mask Airway |
|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 1.3 | 63.5 years STANDARD_DEVIATION 11 | 61.6 years STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) White | 38 Participants | 84 Participants | 46 Participants |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 23 Participants | 46 Participants | 23 Participants |
| Sex: Female, Male Male | 27 Participants | 54 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Procedure Time (Minutes)
Will be measured as time from start of procedure to end of procedure, as recorded in minutes
Time frame: Up to 270 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Procedure Time (Minutes) | 128.7 minutes | Standard Deviation 4.2 |
| General Anesthesia With Laryngeal Mask Airway | Procedure Time (Minutes) | 137.8 minutes | Standard Deviation 6.1 |
Secondary
Airway Trauma
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Anesthesia With Endotracheal Tube | Airway Trauma | 0 Incidents |
| General Anesthesia With Laryngeal Mask Airway | Airway Trauma | 0 Incidents |
Secondary
Anesthetic Requirements
average amount of intravenous anesthetics
Time frame: Up to 270 minutes
Population: Data not collected for this variable
Secondary
Anesthetic Requirements
average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)
Time frame: Up to 270 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Anesthetic Requirements | 0.78 Minimum Alveolar Concentration (MAC) | Standard Error 0.02 |
| General Anesthesia With Laryngeal Mask Airway | Anesthetic Requirements | 0.76 Minimum Alveolar Concentration (MAC) | Standard Error 0.03 |
Secondary
Aspiration Events
aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
Time frame: Up to 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Anesthesia With Endotracheal Tube | Aspiration Events | 0 Events |
| General Anesthesia With Laryngeal Mask Airway | Aspiration Events | 0 Events |
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
Time frame: From end of procedure to six month followup holter monitor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| General Anesthesia With Endotracheal Tube | Atrial Fibrillation Recurrence | 2 incidents |
| General Anesthesia With Laryngeal Mask Airway | Atrial Fibrillation Recurrence | 2 incidents |
Secondary
Cost Analysis
an analysis of cost to patient as well as overall hospital costs will be conducted
Time frame: Up to six months
Population: Data not collected
Secondary
Electrophysiology Parameters
left ventricular ejection fraction
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Electrophysiology Parameters
duration of paroxysmal atrial fibrillation prior to procedure
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Electrophysiology Parameters
size of left atrium (mm)
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Fluoroscopy Time
As measured and reported by electrophysiology and radiology notes, recorded in minutes
Time frame: Up to 270 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Fluoroscopy Time | 27.1 minutes | Standard Error 1.7 |
| General Anesthesia With Laryngeal Mask Airway | Fluoroscopy Time | 28.7 minutes | Standard Error 1.9 |
Secondary
Intraoperative Hemodynamics
systolic blood pressure
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Intraoperative Hemodynamics
heart rate (beats per minute)
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Intraoperative Hemodynamics
mean arterial pressure
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Intraoperative Hemodynamics
diastolic blood pressure
Time frame: Up to 270 minutes
Population: Data was not collected
Secondary
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
Time frame: Up to 270 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Intraprocedure Pressor/Ionotrope/Chronotrope Requirements | total intra-procedule ephedrine | 8.8 milligrams | Standard Error 2.2 |
| General Anesthesia With Endotracheal Tube | Intraprocedure Pressor/Ionotrope/Chronotrope Requirements | total intra-procedule phenylephrine | 0.2 milligrams | Standard Error 0.03 |
| General Anesthesia With Laryngeal Mask Airway | Intraprocedure Pressor/Ionotrope/Chronotrope Requirements | total intra-procedule ephedrine | 5.4 milligrams | Standard Error 1.6 |
| General Anesthesia With Laryngeal Mask Airway | Intraprocedure Pressor/Ionotrope/Chronotrope Requirements | total intra-procedule phenylephrine | 5.5 milligrams | Standard Error 5.2 |
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
Time frame: Up to six months
Population: Not all participant provided survey data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Patient Satisfaction | Satisfied | 9 Participants |
| General Anesthesia With Endotracheal Tube | Patient Satisfaction | Very dissatisfied | 0 Participants |
| General Anesthesia With Endotracheal Tube | Patient Satisfaction | Very satisfied | 34 Participants |
| General Anesthesia With Laryngeal Mask Airway | Patient Satisfaction | Very satisfied | 36 Participants |
| General Anesthesia With Laryngeal Mask Airway | Patient Satisfaction | Satisfied | 6 Participants |
| General Anesthesia With Laryngeal Mask Airway | Patient Satisfaction | Very dissatisfied | 2 Participants |
Secondary
Post-procedure Emesis
Measured by number of times patient has emesis during post-procedure time period
Time frame: Up to 7 days
Population: Data not collected for this variable
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
Time frame: Up to 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Post-procedure Nausea | 0.3 Milligrams | Standard Error 0.2 |
| General Anesthesia With Laryngeal Mask Airway | Post-procedure Nausea | 0.9 Milligrams | Standard Error 0.3 |
Secondary
Time to Discharge From PACU
time from arrival to PACU until discharge from anesthesia care
Time frame: Up to 7 days
Population: Data not collected for this variable
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
Time frame: Up to 270 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Total Anesthesia Time | 179 minutes | Standard Error 4.9 |
| General Anesthesia With Laryngeal Mask Airway | Total Anesthesia Time | 184.7 minutes | Standard Error 6.3 |
Secondary
Total Intra-procedure Opioids
Measured in mcg of Fentanyl
Time frame: Up to 270 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia With Endotracheal Tube | Total Intra-procedure Opioids | 111.7 mcg | Standard Error 6.8 |
| General Anesthesia With Laryngeal Mask Airway | Total Intra-procedure Opioids | 109.2 mcg | Standard Error 5.4 |