EEG Data Collection to Evaluate New Patient State Index Performance

Not Applicable

Terminated

• Conditions: Surgery
• Interventions: Device: PSI Rev 1.X; Device: PSI Rev 2.X

• Registration Number: NCT02954952
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Study Start: 2016-11-11
• Primary Completion: 2018-01-11
• Study Completion: 2018-01-11
• Results First Submitted: 2019-03-05
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Results First Posted: 2019-08-22
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSI Rev 1.X	PSI Rev 1.X	The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).
PSI Rev 2.X	PSI Rev 2.X	The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).
Standard of care (baseline)	PSI Rev 1.X	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.

Primary Outcome Measures

Name	Time	Method
Wake up Times, PSI 1.X vs. PSI 2.X	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.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States