EEG Data Collection to Evaluate New Patient State Index Performance

Masimo Corporation1 site in 1 country44 target enrollmentNovember 11, 2016

ConditionsSurgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgery
Sponsor: Masimo Corporation
Enrollment: 44
Locations: 1
Primary Endpoint: Wake up Times, PSI 1.X vs. PSI 2.X
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI measurement.

Registry

clinicaltrials.gov

Start Date

November 11, 2016

End Date

January 11, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ASA status of I, II, or III.
•Subjects undergoing general surgery.
•neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.).

Exclusion Criteria

•subjects with any deformities, diseases, or for any other reason that may present proper fit and application of SedLine sensors.
•inability to obtain subject's physiological, vital, demographics, and real time anesthesia data.
•Subjects who are pregnant.
•known history of drug abuse.
•subjects deemed not suitable for study at the discretion of the Principal Investigator.

Outcomes

Primary Outcomes

Wake up Times, PSI 1.X vs. PSI 2.X

Time Frame: From the end of anesthesia to the time of Return of Consciousness

Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group.