Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
Not Applicable
Completed
- Conditions
- Anesthesia
- Interventions
- Device: SedLine Vs Comparator Test Group
- Registration Number
- NCT03865316
- Lead Sponsor
- Masimo Corporation
- Brief Summary
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- Patients 18 years old and older at the time of consent.
- ASA status I, II, or III.
- English-speaking subjects.
- Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
Exclusion Criteria
- Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
- Subjects who are developmentally delayed.
- Subjects deemed not suitable for study at the discretion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SedLine Vs Comparator Test Group SedLine Vs Comparator Test Group -
- Primary Outcome Measures
Name Time Method Correlation of Sedation Indices Performance Across Anesthesia Range Duration of surgery The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UC Davis Medical Center
🇺🇸Sacramento, California, United States