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NCT03865316 Clinical Trial

Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia

Anesthesia Clinical Trial

Official title:
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03865316
Other study ID # APPL0009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2019
Est. completion date March 11, 2021

Study information
Verified date March 2022
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date March 11, 2021
Est. primary completion date March 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• SedLine Vs Comparator Test Group
Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of Sedation Indices Performance Across Anesthesia Range The correlation was computed using 1 min average values between the PSi and the comparator's sedation index. Duration of surgery
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