Bispectral Index Monitoring During Testing in the Electrophysiology Lab

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
James Cook, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00749671
First received: November 13, 2007
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention
Tachycardia, Ventricular
Device: Bispectral index monitoring using Aspect Monitor
Other: Ramsey Sedation Scale

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • A change in OAAS scores of one point at the 30 minute data collection time period. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • comfort [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2007
Estimated Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICD testing
Bispectral Index Monitoring
Device: Bispectral index monitoring using Aspect Monitor
The monitoring of the EEG signal is designed to determine if the sedation is adequate.
Experimental: 2
Ramsey Sedation Scale
Other: Ramsey Sedation Scale
The determination of the degree of sedation is accomplished using an established sedation scale.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749671

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

No publications provided

Responsible Party: James Cook, Director, EP Lab, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00749671     History of Changes
Other Study ID Numbers: 07-186
Study First Received: November 13, 2007
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014