EEG Data Collection to Evaluate New Patient State Index Performance

Masimo

Status

Terminated

Conditions

Surgery

Treatments

Device: PSI Rev 2.X

Device: PSI Rev 1.X

Study type

Interventional

Funder types

Industry

Identifiers

NCT02954952

RAMS0005

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 3 patient groups

Standard of care (baseline)

Other group

Description:

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.

Treatment:

Device: PSI Rev 1.X

PSI Rev 1.X

Experimental group

Description:

The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).

Treatment:

Device: PSI Rev 1.X

PSI Rev 2.X

Experimental group

Description:

The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).