Cardiac Arrest Clinical Trial
Official title:
Electrical Safety of Rescuers in Contact With Patients During Implanted Cardioverter Defibrillator Discharge
Patients at risk of developing life-threatening heart rhythms may require the implantation of
a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart
rhythm and delivers an electrical shock to the heart when indicated, in order to return the
heart back to a normal rhythm. Many thousands of these devices have been implanted and are
electrically active in patients who collapse and need resuscitation.
When a patient with an ICD collapses, the device may discharge without warning while a
rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed
below the left collar bone typically deliver 35-50 J energy when they discharge, but newer
ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when
discharging; typically 50-80J energy.
Rescuers performing external chest compressions on a patient during conventional ICD
discharge have reported the sensation of a painful electrical shock and permanent nerve
damage. In these situations, rescuers appear to have been exposed to electrical current from
the ICD considerably in excess of that which is considered a safe threshold.
Studies of surface current resulting from discharge of conventional ICDs have been reported
in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at
considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs
deliver approximately 50% more energy and have the potential to result in exposure of a
rescuer to even higher currents.
With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers
will soon find themselves exposed to leakage current from these devices, there is a need to
examine the leakage currents arising from these devices and assess any subsequent risk to a
rescuer performing external chest compressions.
Rationale for Study:
When patients undergo elective implantation of an ICD, the device is tested by inducing
ventricular fibrillation (VF) in the patient and allowing the ICD to sense, charge and
discharge in an attempt to shock the patient back into a normal rhythm. This provides a
controlled, elective situation in which to measure the cutaneous current on the patient's
skin which is the current to which a rescuer could potentially be exposed.
By understanding the leakage currents from these devices, the investigators will be able to
better understand the safety of rescuers in contact with patients fitted with an ICD and make
specific recommendations to enable to safe undertaking of uninterrupted external chest
compressions while the ICD may be discharging.
STUDY OBJECTIVES
Primary Objective:
To measure cutaneous leakage current on the chest wall during conventional and S-ICD
discharge.
Secondary Objectives:
To make recommendations based on this data regarding the safety of rescuers in contact with a
patient during ICD discharge.
ENDPOINTS
Primary Endpoint:
Maximum cutaneous current measured at multiple sites on the chest wall during ICD discharge.
STUDY DESIGN This is a prospective cohort study, aiming to study sequential patients
undergoing elective ICD implantation and testing over a 12 month period at University
Hospital Southampton.
The patient will undergo elective ICD implantation according to normal protocol. There will
be no change in their treatment. After induction of general anaesthesia, an array of small
self-adhesive electrodes (similar to ECG 'dots') will be placed on the patient's chest wall,
and connected to a multichannel recording device.
After implantation of the ICD, the device will be tested as per normal protocol. VF is
induced in the patient. The ICD senses this arrhythmia, charges and immediately delivers a
shock to the myocardium. As this shock is delivered, the investigators will record the
current reaching the surface electrode array using the multichannel recorder. Most patients
only require one shock as defibrillation rates with ICDs are >90%. If a second shock is
required, the ICD will charge automatically and discharge once again. If this occurs, the
investigators will also measure the cutaneous current at this second, higher energy level.
The study is then concluded. Any subsequent shocks are delivered through external paddles and
the investigators would not require any data from this stage of the procedure.
STUDY POPULATION Number of Participants The investigators aim to assess 20 patients
undergoing conventional ICD implantation and a further 20 patients undergoing S-ICD
implantation.
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