Bispectral Index Monitoring During Testing in the Electrophysiology Lab
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes [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 [30 minutes]
The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.
Eligibility Criteria
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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
Sponsors and Collaborators
- Baystate Medical Center
Investigators
- Principal Investigator: james cook, md, Baystate Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07-186
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bispectral Index Monitoring | Ramsey Scale Monitoring |
|---|---|---|
| Arm/Group Description | Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. | Group assigned to sedation monitoring using the Ramsey Scale for ICD testing |
| Period Title: Overall Study | ||
| STARTED | 11 | 9 |
| COMPLETED | 11 | 9 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | ICD Testingwith Bispectral Monitoring | Nurse Administered Moderate Sedation | Total |
|---|---|---|---|
| Arm/Group Description | Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. | Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient | Total of all reporting groups |
| Overall Participants | 11 | 9 | 20 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
11
100%
|
9
100%
|
20
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Male |
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Region of Enrollment (participants) [Number] | |||
| United States |
11
100%
|
9
100%
|
20
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ICD Testing | ICD testing2 |
|---|---|---|
| Arm/Group Description | Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. | Ramsey Sedation Scale Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale. |
| Measure Participants | 11 | 9 |
| Mean (95% Confidence Interval) [units on a scale] |
4.27
|
4.33
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ICD Testing BIS | ICD Testing Ramsey |
|---|---|---|
| Arm/Group Description | Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT. Bispectral index monitoring: The monitoring of the EEG signal is designed to determine if the sedation is adequate. | Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale. |
| Measure Participants | 11 | 9 |
| Number [percentage of patients with DFT recall] |
0
|
0
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | ICD Testingwith Bispectral Monitoring | Nurse Administered Moderate Sedation | ||
| Arm/Group Description | Bispectral Index Monitoring Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate. | Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient | ||
All Cause Mortality |
||||
| ICD Testingwith Bispectral Monitoring | Nurse Administered Moderate Sedation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| ICD Testingwith Bispectral Monitoring | Nurse Administered Moderate Sedation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ICD Testingwith Bispectral Monitoring | Nurse Administered Moderate Sedation | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/11 (0%) | 0/9 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | James R. Cook MD |
|---|---|
| Organization | Baystate |
| Phone | 413-794-4492 |
| james.cook@bhs.org |
- 07-186