EEG Data Collection to Evaluate New Patient State Index Performance
Not Applicable
Terminated
- Conditions
- Surgery
- Registration Number
- NCT02954952
- Lead Sponsor
- Masimo Corporation
- Brief Summary
This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI measurement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- ASA status of I, II, or III.
- Subjects undergoing general surgery.
- neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.).
Exclusion Criteria
- subjects with any deformities, diseases, or for any other reason that may present proper fit and application of SedLine sensors.
- inability to obtain subject's physiological, vital, demographics, and real time anesthesia data.
- Subjects who are pregnant.
- known history of drug abuse.
- subjects deemed not suitable for study at the discretion of the Principal Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Wake up Times, PSI 1.X vs. PSI 2.X From the end of anesthesia to the time of Return of Consciousness Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms underlying the newer PSI measurement in NCT02954952?
How does the updated Patient State Index compare to standard-of-care EEG monitoring in surgical patients?
Are there specific biomarkers that correlate with improved outcomes using Masimo SedLine's new PSI?
What adverse events are associated with newer PSI technology during anesthesia in NCT02954952?
How does Masimo's updated PSI algorithm differ from competitor EEG monitoring systems in surgical settings?
Trial Locations
- Locations (1)
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Baylor University Medical Center🇺🇸Dallas, Texas, United States