Bispectral Index Monitoring During Testing in the Electrophysiology Lab

Study Overview
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Brief Summary
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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 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.

Detailed Description
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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.

Official Title
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To Assess the Utility of BIS Monitoring in the Administration of Moderate Sedation in Patients Undergoing Implantable Cardioverter -Defibrillator (ICD) Implantation With Defibrillatory Threshold (DFT) Testing

Conditions
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Tachycardia, Ventricular

Intervention / Treatment
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* Device: Bispectral index monitoring
* Other: Ramsey Sedation Scale


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICD testing BIS<br>Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT. | Device: Bispectral index monitoring<br>* The monitoring of the EEG signal is designed to determine if the sedation is adequate.<br>|
| Active Comparator: ICD testing Ramsey<br>Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT | Other: Ramsey Sedation Scale<br>* The determination of the degree of sedation is accomplished using an established sedation scale.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes | Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness: OAAS score 5-awake and responds readily to name spoken in normal tone. OAAS score 4-lethargic responses to name in normal tone. OAAS score 3-responds only after name is called loudly and/or repeatedly. OAAS score 2-responds only after name called loudly and mild shaking. OAAS score 1-does not respond when name is called loudly and mild shaking or prodding. OAAS score 0-does not respond to noxious stimulation. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Recall of Defibrillation Testing | The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no. | 30 minutes |