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EEG Data Collection to Evaluate New Patient State Index Performance

NCT02954952 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-08-22

Study results available
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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.

Conditions

  • Surgery

Interventions

DEVICE

PSI Rev 1.X

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

DEVICE

PSI Rev 2.X

PSI Rev 2.X is a newer version of the PSI measurement.

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Principal Investigators

  • Michael Ramsay, M.D. · Baylor Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-11
Primary Completion
2018-01-11
Completion
2018-01-11
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 NCT02954952 on ClinicalTrials.gov