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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia

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