Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | January 25, 2019 |
| End Date: | July 25, 2019 |
| Contact: | Vikram Ramakanth, DE |
| Email: | clinicalresearchdept@masimo.com |
| Phone: | 949-297-7416 |
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.
device systems during surgery. Relative accuracy of the individual depth of sedation indices
will be compared.
Monitoring vital signs (pulse rate, respiratory rate, blood pressure, and temperature),
respiratory, and anesthesia parameters is considered standard for managing patients during
anesthesia. However, the end target organ of action for anesthetic agents (the brain) is not
routinely monitored. Processed EEG-based monitor index such as Patient State Index (PSI™)
have been shown to be useful in assessing brain activity during sedation and general
anesthesia. Due to the absence of an invasive gold standard to measure sedation, accuracy of
any sedation index cannot be computed. However, correlation with the anesthesia drugs or
sedation scales are generally used to determine the performance of the sedation index.
respiratory, and anesthesia parameters is considered standard for managing patients during
anesthesia. However, the end target organ of action for anesthetic agents (the brain) is not
routinely monitored. Processed EEG-based monitor index such as Patient State Index (PSI™)
have been shown to be useful in assessing brain activity during sedation and general
anesthesia. Due to the absence of an invasive gold standard to measure sedation, accuracy of
any sedation index cannot be computed. However, correlation with the anesthesia drugs or
sedation scales are generally used to determine the performance of the sedation index.
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.
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