Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
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.