EEG Data Collection to Evaluate New Patient State Index Performance

Masimo Corporation44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

PSI Rev 1.XDEVICE

PSI Rev 1.X is an older version of the PSI measurement.

PSI Rev 2.XDEVICE

PSI Rev 2.X is a newer version of the PSI measurement.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

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.

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

Data from ClinicalTrials.gov

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