Bispectral Index Monitoring During Testing in the Electrophysiology Lab
Primary Purpose
Tachycardia, Ventricular
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bispectral index monitoring
Ramsey Sedation Scale
Sponsored by
About this trial
This is an interventional supportive care trial for Tachycardia, Ventricular
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.
Sites / Locations
- Baystate Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ICD testing BIS
ICD testing Ramsey
Arm Description
Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.
Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient Recall of Defibrillation Testing
The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.
Full Information
NCT ID
NCT00749671
First Posted
November 13, 2007
Last Updated
August 26, 2016
Sponsor
Baystate Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00749671
Brief Title
Bispectral Index Monitoring During Testing in the Electrophysiology Lab
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baystate Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICD testing BIS
Arm Type
Active Comparator
Arm Description
Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.
Arm Title
ICD testing Ramsey
Arm Type
Active Comparator
Arm Description
Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT
Intervention Type
Device
Intervention Name(s)
Bispectral index monitoring
Intervention Description
The monitoring of the EEG signal is designed to determine if the sedation is adequate.
Intervention Type
Other
Intervention Name(s)
Ramsey Sedation Scale
Intervention Description
The determination of the degree of sedation is accomplished using an established sedation scale.
Primary Outcome Measure Information:
Title
Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Patient Recall of Defibrillation Testing
Description
The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
james cook, md
Organizational Affiliation
Baystate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Bispectral Index Monitoring During Testing in the Electrophysiology Lab
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