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

NCT02896595 | Completed Results

• 1 other identifier: HM20007902
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Fluoroscopy Time

  Up to 270 minutes

• Total Anesthesia Time

  Up to 270 minutes

• Time to Discharge From PACU

  Up to 7 days

• Total Intra-procedure Opioids

  Up to 270 minutes

• Anesthetic Requirements

  Up to 270 minutes

Study Arms (2)

General Anesthesia with endotracheal tube

ACTIVE COMPARATOR

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.

Device: General Anesthesia with endotracheal tube

General Anesthesia with laryngeal mask airway

ACTIVE COMPARATOR

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.

Device: General Anesthesia with laryngeal mask airway

Interventions

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 endotracheal tube

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.

General Anesthesia with laryngeal mask airway

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary ablation for paroxysmal atrial fibrillation
• Able to obtain consent in English language
• BMI \<35

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anesthesia, General; Laryngeal Masks

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Praveen Prasanna
• Organization: Virginia Commonwealth University Health Department of Anesthesiology

praveen.prasanna@vcuhealth.org

804-828-2207

Study Officials

• Praveen Prasanna, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 12, 2016
• Study Start: September 1, 2016
• Primary Completion: December 11, 2018
• Study Completion: January 31, 2019
• Last Updated: January 21, 2020
• Results First Posted: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)