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IRCT20130707013886N2 IRCT 2022-11-12 Tehran University of Medical Sciences Vagus nerve stimulation for reducing postoperative atrial fibrillation TRAVAG-POAF Feasibility, acceptability, safety and efficacy of transcutaneous auricular vagus nerve stimulation for reducing postoperative atrial fibrillation in patients undergoing coronary artery bypass graft surgery; A study protocol for a pilot randomized sham-controlled trial 2022-11-01 anticipated 20 Complete https://irct.ir/trial/66317 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization will be done via permuted block technique. Randomization unit will be the blocks with sizes of 2 and 4. Randomization tools in "www.sealedenvelope.com" will be used for performing randomization. Researcher A is responsible for randomization and determine specific codes for each patients. Only those researchers (B and C) who are responsible for performing the intervention will be aware of allocation. Outcome assessors (D) will be blinded from allocation, Blinding description: Participant: In this study, stimulation causes a tingling sensation in the ear area. The participants are told that after the tingling sensation, this feeling may decrease or disappear altogether, which is due to the reduction of sensitivity of the skin of that area. In the active intervention group, this tingling does not change over time or becomes slightly less but does not disappear because it receives constant stimulation. But in the sham group, stimulation is first given for 1 minute (this amount does not produce a clinical effect) so that the patient does not have the mindset that he will not receive the stimulation, and then the stimulation is stopped. Outcome assessor and data analyst: Outcome assessor collect the outcomes without talking to the patient and the researcher who performs the intervention and then send them to the researcher who is responsible for data management and analysis. N/A Postoperative atrial fibrillation. Intervention 1: Intervention group: Exposure to the active status of ta-VNS set to burst pulses of 30 on, 30 s off, 20 Hz frequency, 200 microseconds PW, and at 80% or 0.5 mA current on the left tragus. Active stimulation is turned on for 40 minutes, followed by 20 minutes of rest, and then 40 minutes of stimulation, starting from day 0 and repeated daily until discharge day or day 4. Intervention 2: Control group: Exposure to sham status of ta-VNS that set to the same parameters as active, but transform no current. Sham stimulation is turned on for 40 minutes followed by 20 minutes rest, and then 40 minutes of stimulation, starting from day 0 and repeated daily until discharge day or day 4. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after individuals' identities have been removed. When: Considering that this study is a preliminary study, its data will be published after the main clinical trial. To whom: It will be available for researchers working in academic and scientific institutions. Conditions: The use of data in secondary studies such as systematic reviews and meta-analyses is allowed. Where to obtain: Correspondence with the email of the primary investigator of the study. How to obtain: After reviewing the application in the research team, it will reach the applicant within 1 month. Comments:
public Danesh Soltani
Tehran Heart Center, North Karegar street, Tehran
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9256 soltani.danesh@yahoo.com Tehran University of Medical Sciences scientific Ali Vasheghani-Farahani
Tehran Heart Center, North Karegar st., Tehran
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9721 avasheghani@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult subjects who are candidate for an elective CABG Age ≥ 18 Sinus rhythm at baseline ECG 18 years no limit Both Patients with a documented history of AF and other supraventricular arrhythmia Hemodynamic instability that required inotropic agents Severe congestive heart failure (New York Heart Association class III or IV) Congenital heart disease Chronic use of amiodarone High-degree atrioventricular block that required temporary pacing Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker Recent stroke within the past 6 months Recurrent vasovagal syncope Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia The presence of a pacemaker or an implanted cardioverter-defibrillator Pregnancy Facial or ear pain, or recent ear trauma Unable or unwilling to comply with protocol requirements I48.0 Paroxysmal atrial fibrillation Treatment - Devices N/A Intervention group: Exposure to the active status of ta-VNS set to burst pulses of 30 on, 30 s off, 20 Hz frequency, 200 microseconds PW, and at 80% or 0.5 mA current on the left tragus. Active stimulation is turned on for 40 minutes, followed by 20 minutes of rest, and then 40 minutes of stimulation, starting from day 0 and repeated daily until discharge day or day 4. Control group: Exposure to sham status of ta-VNS that set to the same parameters as active, but transform no current. Sham stimulation is turned on for 40 minutes followed by 20 minutes rest, and then 40 minutes of stimulation, starting from day 0 and repeated daily until discharge day or day 4. Feasibility of the intervention. Timepoint: At the end of the study. Method of measurement: The amount of time (in minutes) of device use per day and Number of completed session. Feasibility of the measurements and assessments procedures. Timepoint: At the end of the study. Method of measurement: The number of completed assessments. Acceptability of the intervention. Timepoint: At the end of the study. Method of measurement: TAQ questionnaire. Safety of the study. Timepoint: After intervention on a daily basis. Method of measurement: Physical examination. Occurrence of in-hospital POAF. Timepoint: Days 0 to 4 (or at discharge day, whichever is earlier). Method of measurement: 24-hour ECG holter monitoring. Time to first POAF event. Timepoint: Patients will be seen on a daily basis from day 0 to day 4 and the timing of first POAF event will be recorded. Method of measurement: 24-hour ECG holter monitoring. Duration of incident post-op atrial fibrillation. Timepoint: Daily assessment from day 0 to day 4 until the first POAF event occurred and recording the duration of that. Method of measurement: 24-hour ECG holter monitoring. Heart rate during incident first POAF event. Timepoint: Daily assessment from day 0 to day 4 until the first POAF event occurred and recording the HR during that. Method of measurement: 24-hour ECG holter monitoring. Changes in heart rate after intervention. Timepoint: before and after intervention on a daily basis. Method of measurement: ICU monitoring device. Changes in blood pressure after intervention. Timepoint: before and after intervention on a daily basis. Method of measurement: ICU monitoring device. Changes in hs-CRP level. Timepoint: Days 0, 2 and 4. Method of measurement: Laboratory assessment. Changes in NT-Pro BNP level. Timepoint: Days 0, 2 and 4. Method of measurement: Laboratory assessment. Changes in CBC parameters. Timepoint: Days 0, 2 and 4. Method of measurement: Laboratory assessment. Days of hospitalization. Timepoint: At discharge day. Method of measurement: The number of hospitalization days. Tehran University of Medical Sciences Approved 2021-11-04 Ethics committee of Tehran Heart Center Tehran Heart Center, North Karegar street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)