EEG Data Collection to Evaluate New Patient State Index Performance

NCT02954952 | Terminated Results FDA Device

• 1 other identifier: RAMS0005
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total Anesthesia Drug Used, PSI 1.X vs. PSI 2.X

  Through study completion

• Frequency of Somatic Events, PSI 1.X vs. PSI 2.X

  Through study completion

Study Arms (3)

Standard of care (baseline)

OTHER

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

EXPERIMENTAL

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

Device: PSI Rev 1.X

PSI Rev 2.X

EXPERIMENTAL

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

Device: PSI Rev 2.X

Interventions

PSI Rev 1.X DEVICE

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

PSI Rev 1.X; Standard of care (baseline)

PSI Rev 2.X DEVICE

PSI Rev 2.X is a newer version of the PSI measurement.

PSI Rev 2.X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

949-297-7416

Study Officials

• Michael Ramsay, M.D.

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: November 11, 2016
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)