EEG Data Collection to Evaluate New Patient State Index Performance

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 Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Device: PSI Rev 1.X; Device: PSI Rev 2.X

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of care (baseline); Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.	Device: PSI Rev 1.X; PSI Rev 1.X is an older version of the PSI measurement.
Experimental: PSI Rev 1.X; The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).	Device: PSI Rev 1.X; PSI Rev 1.X is an older version of the PSI measurement.
Experimental: PSI Rev 2.X; The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).	Device: PSI Rev 2.X; PSI Rev 2.X is a newer version of the PSI measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the end of anesthesia to the time of Return of Consciousness

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Anesthesia Drug Used, PSI 1.X vs. PSI 2.X	Compare the total amount of anesthesia drug used between the PSI 1.X group and the PSI 2.X group.	Through study completion
Frequency of Somatic Events, PSI 1.X vs. PSI 2.X	Compare the frequency of somatic events between the PSI 1.X group and the PSI 2.X group.	Through study completion

Collaborators and Investigators

• Sponsor: Masimo Corporation
• Investigators: Principal Investigator: Michael Ramsay, M.D., Baylor Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2016
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: RAMS0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes