Comparison of Oxygen Interventions and Defibrillator Efficiency

Summary

Background:

Cardiac arrhythmias can be terminated by electrical current applied by an external defibrillator. This treatment, named cardioversion, has been used for decades in the treatment of atrial fibrillation.

Several kinds of defibrillators exist, though the relative efficacy and safety of these defibrillators is not clear.

During cardioversion, oxygen is being administered, and it has been a long-held belief that oxygen is always beneficial for the patient. This is now being challenged by recent studies suggesting excessive oxygenation to be potentially dangerous for the patients.

Objective:

1. To compare the efficiency and safety of two different defibrillators
2. To investigate the effects of excessive oxygen on injury of the heart following cardioversion.

Experimental design:

Patients will be recruited at the outpatient clinic at the Department of Cardiology, Regional Hospital of Randers, Denmark as a part of the pre-cardioversion check.

Patients will be randomized to cardioversion using one of two defibrillators and randomized to treatment with room air or 100% oxygen.

The cardiac condition will be measured by blood samples before cardioversion, 4 hours after cardioversion and 3 months after cardioversion. Heart rhythm will be measured by ECG before cardioversion, 1 minute-, 30 minutes- and 4 hours after cardioversion.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

DEVICE

Cardioversion with a pulsed biphasic waveform

Cardioversion will be performed by a pulsed biphasic (Multipulse Biowave®) waveform (Schiller Defigard 5000) with an energy setting of 90J, 120J, 150J, 200J. Primary endpoint: The proportion of patients in sinus rhythm four hours post cardioversion.

PROCEDURE

Normoxia during cardioversion

Patients will be treated with room air with a flow of 10-15 L/minute for 3 minutes prior to cardioversion and nasal room air with a flow of 3 L/minute for 30 minutes following cardioversion

DEVICE

Cardioversion with a biphasic truncated exponential waveform

Cardioversion will be performed by a biphasic truncated exponential waveform (LIFEPAK 20), with a energy setting of 100J, 150J, 200J, 250J. Primary endpoint: The proportion of patients in sinus rhythm four hours post cardioversion.

PROCEDURE

Hyperoxia during cardioversion

Patients will be treated with 100% oxygen with a flow of 10-15 L/minute for 3 minutes prior to cardioversion and nasal 100% oxygen with a flow of 3 L/minute for 30 minutes following cardioversion

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Randers Regional Hospital

  lead OTHER

Principal Investigators

• Bo Løfgren, MD, PhD · Randers Regional Hospital

• Kasper G. Lauridsen, MB · Randers Regional Hospital

• Anders S. Schmidt, MB · Randers Regional Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2014-12-31

Completion

2016-01-31

Countries

• Denmark

Study Locations