Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2019
CompletedFirst Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2021
CompletedResults Posted
Study results publicly available
April 11, 2022
CompletedApril 11, 2022
March 1, 2022
2.1 years
February 4, 2019
March 11, 2022
March 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
SedLine Vs Comparator Test Group
EXPERIMENTALInterventions
Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Eligibility Criteria
You may qualify if:
- 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.).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Medical Center
Sacramento, California, 95817, United States
Related Publications (1)
Jones JH, Nittur VR, Fleming N, Applegate RL 2nd. Simultaneous comparison of depth of sedation performance between SedLine and BIS during general anesthesia using custom passive interface hardware: study protocol for a prospective, non-blinded, non-randomized trial. BMC Anesthesiol. 2021 Apr 6;21(1):105. doi: 10.1186/s12871-021-01326-5.
PMID: 33823811DERIVED
Results Point of Contact
- Title
- Cristina Johnson
- Organization
- Masimo Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2019
First Posted
March 6, 2019
Study Start
January 25, 2019
Primary Completion
March 11, 2021
Study Completion
March 11, 2021
Last Updated
April 11, 2022
Results First Posted
April 11, 2022
Record last verified: 2022-03