Bispectral Index Monitoring During Testing in the Electrophysiology Lab

NCT ID: NCT00749671

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2013-08-31

Brief Summary

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

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.

Conditions

Tachycardia, Ventricular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ICD testing BIS

Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.

Group Type: ACTIVE_COMPARATOR

Bispectral index monitoring

Intervention Type: DEVICE

The monitoring of the EEG signal is designed to determine if the sedation is adequate.

ICD testing Ramsey

Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT

Group Type: ACTIVE_COMPARATOR

Ramsey Sedation Scale

Intervention Type: OTHER

The determination of the degree of sedation is accomplished using an established sedation scale.

Interventions

Bispectral index monitoring

The monitoring of the EEG signal is designed to determine if the sedation is adequate.

Intervention Type: DEVICE

Ramsey Sedation Scale

The determination of the degree of sedation is accomplished using an established sedation scale.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baystate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Cook

Director, EP Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

james cook, md

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Locations

Baystate Medical Center

Springfield, Massachusetts, United States

Countries

United States

Other Identifiers

07-186

Identifier Type: -

Identifier Source: org_study_id