Tachycardia, Ventricular
Conditions
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.
Interventions
The monitoring of the EEG signal is designed to determine if the sedation is adequate.
The determination of the degree of sedation is accomplished using an established sedation scale.
Sponsors
Baystate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Nurse Administered Moderate Sedation Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | ICD Testingwith Bispectral Monitoring | Nurse Administered Moderate Sedation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 9 Participants | 20 Participants |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
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.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ICD Testing | Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes | 4.27 units on a scale |
| ICD testing2 | Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes | 4.33 units on a 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.
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Testing | Patient Recall of Defibrillation Testing | 0 percentage of patients with DFT recall |
| ICD testing2 | Patient Recall of Defibrillation Testing | 0 percentage of patients with DFT recall |