Bispectral Index Monitoring During Testing in the Electrophysiology Lab

BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been
the standard of practice for patients undergoing a wide range of electrophysiology
procedures during the past decade. Currently a subjective sedation assessment tool is the
standard of practice within the Electrophysiology Lab (EP Lab). Bispectral Index monitoring
(BIS) is an objective measure of the depth of sedation presently employed at Baystate
Medical Center in the Intensive Care Unit and within the department of anesthesia.

AIM The aim of this research study is to assess the utility of BIS monitoring in measuring
the depth of sedation in patients undergoing defibrillation threshold testing (DFT). Our
primary endpoint is: A change in Observer's Assessment of Alertness/Sedation Scales (OAAS)
scores of one point at the 30 minute data collection time period.

Our secondary endpoints are: Lack of explicit recall of DFT testing and measurement of
perioperative level of comfort.

STUDY DESIGN AND SCOPE The population to be studied is those patients receiving a primary
ICD implant or an ICD battery change with defibrillation threshold testing (DFT).

All patients who have consented for ICD placement and DFT testing with moderate sedation
will be invited to participate in this research study. Patients who are not candidates for
DFT testing, as is determined by the EP physician, will be excluded from the study.

Demographic data including: age, gender, BMI, current medications and history of sleep apnea
will be collected. Data detailing the amount of drug administered during the procedure and
any use of reversal agents, will be retrieved from the medical record.

The study will be conducted within the Electrophysiology lab at Baystate Medical Center. An
enrollment of 60 subjects is expected to be completed within 6 months. 30 patients will
originate from the outpatient population and 30 from the inpatient.

Follow up assessments using the OAAS scale will be completed at 30 min, 1 hour and 4 hours
post procedure. Also, perioperative comfort and recall of DFT testing will be assessed at
the 4 hour mark.

Inclusion Criteria:

- All patients who are having ICD placement and DFT testing will be invited to
participate in this research study.

Exclusion Criteria:

- Patients who are not candidates for DFT testing, as is determined by the EP physician

- An example of such a patient would be one who is hemodynamically unstable;

- DFT testing is contraindicated in this case.