EEG Data Collection to Evaluate New Patient State Index P... | NCT02954952

NCT02954952

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Frequency of Somatic Events, PSI 1.X vs. PSI 2.X

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Michael Ramsay, M.D.	Baylor Health Care System	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University Medical Center		Dallas	Texas	75246	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Standard of Care (Baseline)	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. PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
FG001	PSI Rev 1.X	The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X). PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
FG002	PSI Rev 2.X	The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X). PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00036 subjects FG0015 subjects FG0023 subjects
COMPLETED		FG00035 subjects FG0014 subjects FG0023 subjects
NOT COMPLETED		FG0001 subjects FG0011 subjects FG0020 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0010 subjects FG0020 subjects
No data collected		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Standard of Care (Baseline)	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. PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Data were not collected.

Posted

From the end of anesthesia to the time of Return of Consciousness

ID	Title	Description
OG000	Standard of Care (Baseline)	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. PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
OG001	PSI Rev 1.X

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard of Care (Baseline)	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. PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Director of Clinical Research	Masimo Corporation	949-297-7416		clinicalresearchdept@masimo.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 2, 2016	Feb 22, 2019	Prot_SAP_000.pdf

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

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