Atrial FibrillationNCT02896595
General Anesthesia With ETT vs LMA in Patients Undergoing Ablation for Atrial Fibrillation
A study testing General Anesthesia with endotracheal tube and General Anesthesia with laryngeal mask airway in people with Atrial Fibrillation, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- General Anesthesia with endotracheal tube and General Anesthesia with laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary ablation for paroxysmal atrial fibrillation
- Able to obtain consent in English language
- BMI <35
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial
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.
Read more
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
- Being tested
- General Anesthesia with endotracheal tube, General Anesthesia with laryngeal mask airway
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia with endotracheal tubeDevice
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 airwayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: General Anesthesia with laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Time (Minutes)
Will be measured as time from start of procedure to end of procedure, as recorded in minutes
Measured: Up to 270 minutes
Secondary outcomes (21)
Fluoroscopy Time
As measured and reported by electrophysiology and radiology notes, recorded in minutes
Measured: Up to 270 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
Measured: Up to 270 minutes
Time to Discharge From PACU
time from arrival to PACU until discharge from anesthesia care
Measured: Up to 7 days
Total Intra-procedure Opioids
Measured in mcg of Fentanyl
Measured: Up to 270 minutes
Anesthetic Requirements
average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)
Measured: Up to 270 minutes
Anesthetic Requirements
average amount of intravenous anesthetics
Measured: Up to 270 minutes
Intraoperative Hemodynamics
heart rate (beats per minute)
Measured: Up to 270 minutes
Intraoperative Hemodynamics
mean arterial pressure
Measured: Up to 270 minutes
Intraoperative Hemodynamics
systolic blood pressure
Measured: Up to 270 minutes
Intraoperative Hemodynamics
diastolic blood pressure
Measured: Up to 270 minutes
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively
Measured: Up to 270 minutes
Electrophysiology Parameters
duration of paroxysmal atrial fibrillation prior to procedure
Measured: Up to 270 minutes
Electrophysiology Parameters
size of left atrium (mm)
Measured: Up to 270 minutes
Electrophysiology Parameters
left ventricular ejection fraction
Measured: Up to 270 minutes
Airway Trauma
Any noted trauma in the anesthesia or post-procedure notes, including damage to lips/teeth, laryngospasm, need for reintubation post procedure
Measured: Up to 7 days
Post-procedure Nausea
Measured by number of doses of antiemetics given in the post-procedure time period mg of Zofran (ondanesteron) given post-operatively
Measured: Up to 7 days
Post-procedure Emesis
Measured by number of times patient has emesis during post-procedure time period
Measured: Up to 7 days
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
Measured: From end of procedure to six month followup holter monitor
Aspiration Events
aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented
Measured: Up to 7 days
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
Measured: Up to six months
Cost Analysis
an analysis of cost to patient as well as overall hospital costs will be conducted
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion11 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praveen Prasanna, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896595
- Sponsor's protocol ID
- HM20007902
- Status last verified
- Jan 2020
- First submitted
- 29 Aug 2016
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia With Endotracheal Tube Versus Laryngeal Mask Airway in Patients Undergoing Catheter Ablation for Atrial Fibrillation, a Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02896595
- Acronym / sponsor ID
- HM20007902
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia with endotracheal tube | Active comparator | Device: General Anesthesia with endotracheal tubePatients 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 laryngeal mask airway | Active comparator | Device: General Anesthesia with laryngeal mask airwayPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing primary ablation for paroxysmal atrial fibrillation
- Able to obtain consent in English language
- BMI <35
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Anesthesia with endotracheal tubePatient 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. | Device | General Anesthesia with endotracheal tube |
| General Anesthesia with laryngeal mask airwayPatients 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. | Device | General Anesthesia with laryngeal mask airway |
Primary outcome
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
21 secondary outcomes
Fluoroscopy Time
Time frame: Up to 270 minutes
Total Anesthesia Time
Time frame: Up to 270 minutes
Time to Discharge From PACU
Time frame: Up to 7 days
Total Intra-procedure Opioids
Time frame: Up to 270 minutes
Anesthetic Requirements
Time frame: Up to 270 minutes
Anesthetic Requirements
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
Time frame: Up to 270 minutes
Intraoperative Hemodynamics
Time frame: Up to 270 minutes
Intraprocedure Pressor/Ionotrope/Chronotrope Requirements
Time frame: Up to 270 minutes
Electrophysiology Parameters
Time frame: Up to 270 minutes
Electrophysiology Parameters
Time frame: Up to 270 minutes
Electrophysiology Parameters
Time frame: Up to 270 minutes
Airway Trauma
Time frame: Up to 7 days
Post-procedure Nausea
Time frame: Up to 7 days
Post-procedure Emesis
Time frame: Up to 7 days
Atrial Fibrillation Recurrence
Time frame: From end of procedure to six month followup holter monitor
Aspiration Events
Time frame: Up to 7 days
Patient Satisfaction
Time frame: Up to six months
Cost Analysis
Time frame: Up to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Prasanna, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia with endotracheal tube and General Anesthesia with laryngeal mask airway in people with Atrial Fibrillation, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Time (Minutes) (time frame: Up to 270 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.