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NCT00749671 · ClinicalTrials.gov registry record · NA
Bispectral Index Monitoring During Testing in the Electrophysiology Lab
A NA study, sponsored by Baystate Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT00749671 is a NA study that was terminated before completion, run by Baystate Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT00749671, a NA study, was terminated before completion, sponsored by Baystate Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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
Interventions
- DEVICE Bispectral index monitoring
- OTHER Ramsey Sedation Scale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00749671
The ClinicalTrials.gov registry entry for NCT00749671 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bispectral index monitoring is the first listed.
NCT00749671 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00749671 about?
NCT00749671 is a clinical study titled "Bispectral Index Monitoring During Testing in the Electrophysiology Lab". 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 Elec...
What is the current status of trial NCT00749671?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2007-10. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00749671?
The interventions under investigation include: Bispectral index monitoring (DEVICE), Ramsey Sedation Scale (OTHER).
Who is sponsoring clinical trial NCT00749671?
This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.
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