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Lack of enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD testing BIS | Active Comparator | Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT. |
|
| ICD testing Ramsey | Active Comparator | Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bispectral index monitoring | Device | The monitoring of the EEG signal is designed to determine if the sedation is adequate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Recall of Defibrillation Testing | The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| james cook, md | Baystate Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bispectral Index Monitoring | Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. |
| FG001 | Ramsey Scale Monitoring | Group assigned to sedation monitoring using the Ramsey Scale for ICD testing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ICD Testingwith Bispectral Monitoring | Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. |
| BG001 | Nurse Administered Moderate Sedation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICD Testingwith Bispectral Monitoring | Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James R. Cook MD | Baystate | 413-794-4492 | james.cook@bhs.org |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Ramsey Sedation Scale | Other | The determination of the degree of sedation is accomplished using an established sedation scale. |
|
Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | While gender was recorded at baseline, we no longer have access to the dataset to tabulate | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | ICD testing2 | Ramsey Sedation Scale Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale. |
|
|
| Secondary | Patient Recall of Defibrillation Testing | The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no. | Posted | Number | percentage of patients with DFT recall | 30 minutes |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Nurse Administered Moderate Sedation | Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient | 0 | 9 | 0 | 9 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |