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

NCT03865316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-04-11

Study results available
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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.

Conditions

  • Anesthesia

Interventions

DEVICE

SedLine Vs Comparator Test Group

Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2021-03-11
Completion
2021-03-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865316 on ClinicalTrials.gov