- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00749671
Bispectral Index Monitoring During Testing in the Electrophysiology Lab
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ICD testing BIS
Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.
|
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
|
The determination of the degree of sedation is accomplished using an established sedation scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: james cook, md, Baystate Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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