EEG Data Collection to Evaluate New Patient State Index Performance

Surgery Clinical Trial

Official title:

EEG Data Collection to Evaluate New Patient State Index Performance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02954952
• Other study ID #: RAMS0005
• Status: Terminated
• Phase: N/A
• Start date: November 11, 2016
• Est. completion date: January 11, 2018

Study information

• Verified date: August 2019
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• PSI Rev 1.X
PSI Rev 1.X is an older version of the PSI measurement.
• PSI Rev 2.X
PSI Rev 2.X is a newer version of the PSI measurement.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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