Trial Outcomes & Findings for General Anesthesia With ETT vs LMA in Patients Undergoing Ablation for Atrial Fibrillation (NCT NCT02896595)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Up to 270 minutes

Results posted on

2020-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.	Total n=100 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 1.3 • n=93 Participants	61.6 years STANDARD_DEVIATION 1.8 • n=4 Participants	63.5 years STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	27 Participants n=4 Participants	54 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	38 Participants n=93 Participants	46 Participants n=4 Participants	84 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment United States	50 participants n=93 Participants	50 participants n=4 Participants	100 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 270 minutes

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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Procedure Time (Minutes)	128.7 minutes Standard Deviation 4.2	137.8 minutes Standard Deviation 6.1

SECONDARY outcome

Timeframe: Up to 270 minutes

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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Fluoroscopy Time	27.1 minutes Standard Error 1.7	28.7 minutes Standard Error 1.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Total Anesthesia Time	179 minutes Standard Error 4.9	184.7 minutes Standard Error 6.3

SECONDARY outcome

Timeframe: Up to 7 days

Population: Data not collected for this variable

time from arrival to PACU until discharge from anesthesia care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Measured in mcg of Fentanyl

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Total Intra-procedure Opioids	111.7 mcg Standard Error 6.8	109.2 mcg Standard Error 5.4

SECONDARY outcome

Timeframe: Up to 270 minutes

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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Anesthetic Requirements	0.78 Minimum Alveolar Concentration (MAC) Standard Error 0.02	0.76 Minimum Alveolar Concentration (MAC) Standard Error 0.03

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data not collected for this variable

average amount of intravenous anesthetics

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

heart rate (beats per minute)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

mean arterial pressure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

systolic blood pressure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

diastolic blood pressure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements total intra-procedule ephedrine	8.8 milligrams Standard Error 2.2	5.4 milligrams Standard Error 1.6
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements total intra-procedule phenylephrine	0.2 milligrams Standard Error 0.03	5.5 milligrams Standard Error 5.2

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

duration of paroxysmal atrial fibrillation prior to procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

size of left atrium (mm)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 270 minutes

Population: Data was not collected

left ventricular ejection fraction

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Airway Trauma	0 Incidents	0 Incidents

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Post-procedure Nausea	0.3 Milligrams Standard Error 0.2	0.9 Milligrams Standard Error 0.3

SECONDARY outcome

Timeframe: Up to 7 days

Population: Data not collected for this variable

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Atrial Fibrillation Recurrence	2 incidents	2 incidents

SECONDARY outcome

Timeframe: Up to 7 days

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

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=50 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=50 Participants 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.
Aspiration Events	0 Events	0 Events

SECONDARY outcome

Timeframe: Up to six months

Population: Not all participant provided survey data

patients will be given an survey by study personnel prior to discharge from the hospital; survey will be conducted in person by study personnel

Outcome measures

Outcome measures
Measure	General Anesthesia With Endotracheal Tube n=43 Participants 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.	General Anesthesia With Laryngeal Mask Airway n=44 Participants 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.
Patient Satisfaction Satisfied	9 Participants	6 Participants
Patient Satisfaction Very satisfied	34 Participants	36 Participants
Patient Satisfaction Very dissatisfied	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to six months

Population: Data not collected

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

Outcome measures

Outcome data not reported

Adverse Events

General Anesthesia With Endotracheal Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia With Laryngeal Mask Airway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Praveen Prasanna

Virginia Commonwealth University Health Department of Anesthesiology

Phone: 804-828-2207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place