Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency
      department (ED) patients. If the irregular heartbeat has been present for less than 48 hours,
      there is a chance that emergency treatment can convert the heartbeat into normal rhythm.

      There are currently two options for accomplishing this; both are widely and safely used in
      EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1)
      Patients are given an intravenous medication called procainamide; this converts patients into
      a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep with a
      general anesthetic) for about ten minutes, while an electrical current is conducted across
      the chest; this converts patients into a normal heart rhythm around 90% of the time.

      Procainamide can cause low blood pressure in about 10% of patients; this is usually corrected
      by administering intravenous fluids. Sedation can cause low blood pressure in about 10% of
      patients, and breathing trouble in about 10% of patients; this is usually corrected by
      administering intravenous fluids, and administering more oxygen, respectively. In thousands
      of patients studied around the world, there does not appear to have been a reported stroke or
      death as a result of these procedures.

      A physician will choose one method, but if it fails, will move to the next method. There are
      thus two options. (1) Chemical conversion, followed by electrical conversion; and (2)
      Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+
      chance of converting AF into a normal heart rhythm. However, the investigators believe that
      an electrical-chemical sequence will be faster than a chemical-electrical sequence, while
      both will be equally safe.

      If patients agree to take part in the study, they will be randomized to one of the two
      options. They will have their breathing, oxygen levels, blood pressure, and heartbeat
      monitored for their entire ED stay.

      The investigators plan to enrol 86 patients at five hospitals over the course of about one
      year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as
      conversion to normal rhythm, and adverse events (such as trouble breathing or low blood
      pressure) will be documented. In addition, an investigator will contact you at three and
      thirty days after your visit to make sure that there are no problems. Importantly, although
      the principal and site investigators will be aware of the primary outcome, attending
      emergency physicians who actually provide patient care will NOT be aware of the primary
      outcome--otherwise this could bias patient management.

      When the study is finished, the results will be given to the writing committee merely as the
      "A" and "B" arms, and not specified as either the "chemical-first" or "electrical-first"
      arms. The writing committee will compose two manuscripts, (1) assuming that "A" is the
      "chemical-first" arm and "B" the "electrical-first" arm, and (2) assuming that "A" is the
      "electrical-first"arm, and "B" the "chemical-first" arm. After both manuscripts have been
      approved by all authors, the blinding will be removed and only the correct manuscript
      submitted for publication.
    


Intervention name(s): Electrical-first; Chemical-first
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be placed on cardiopulmonary blood pressure monitoring, and sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient. If atrial fibrillation is maintained, the patient will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient, otherwise a cardiologist will be consulted.; Patients will be placed on cardiopulmonary blood pressure monitoring, and will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient. If the rhythm has not changed, then the patient will be continue to have cardiopulmonary monitoring, but also be attended by a respiratory therapist. The patient will be sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient, otherwise a cardiologist will be consulted.
Other intervention name(s): DC cardioversion; procainamide
Intervention MeSH terms: Procainamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment