Bispectral Index Monitoring During Testing in the Electrophysiology Lab

• ClinicalTrials.gov Identifier: NCT00749671
• Recruitment Status: Terminated
• First Posted: September 9, 2008
• Results First Posted: October 19, 2016
• Last Update Posted: October 19, 2016
• Sponsor: Baystate Medical Center
• Information provided by (Responsible Party): James Cook, Baystate Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tachycardia, Ventricular	Device: Bispectral index monitoring; Other: Ramsey Sedation Scale	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Study Start Date: October 2007
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes [ Time Frame: 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.

Secondary Outcome Measures :

1. Patient Recall of Defibrillation Testing [ Time Frame: 30 minutes ]
   The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Sponsors and Collaborators

Baystate Medical Center

Investigators

• Principal Investigator: james cook, md; Baystate Medical Center

More Information

• Responsible Party: James Cook, Director, EP Lab, Baystate Medical Center
• ClinicalTrials.gov Identifier: NCT00749671
• Other Study ID Numbers: 07-186
• First Posted: September 9, 2008
• Results First Posted: October 19, 2016
• Last Update Posted: October 19, 2016
• Last Verified: September 2015

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes