EEG Data Collection to Evaluate New Patient State Index Performance

Stopped early · Not applicable

Conditions studied: Surgery

In brief

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.

Key facts

Study ID

NCT02954952

Run by

Masimo Corporation

People needed

44

Starts

2016-11-11

Expected to finish

2018-01-11

Last updated by the study team

2019-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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