EEG Data Collection to Evaluate New Patient State Index Performance
NCT ID: NCT02954952
Last Updated: 2019-08-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
44 participants
INTERVENTIONAL
2016-11-11
2018-01-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sedline EEG Guided Depth of Anesthesia
NCT05051982
Neurophysiological Intraoperative or Epilepsy Monitoring
NCT01630785
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram
NCT01256749
Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.
NCT02875964
Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy
NCT03533530
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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PSI Rev 2.X is a newer version of the PSI measurement.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects undergoing general surgery.
* neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Masimo Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Ramsay, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Baylor University Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RAMS0005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.