SurgeryNCT02954952
EEG Data Collection to Evaluate New Patient State Index Performance
A study testing PSI Rev 1.X and PSI Rev 2.X in people with Surgery, run by Masimo Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- PSI Rev 1.X and PSI Rev 2.X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2016to 11 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
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
- Being tested
- PSI Rev 1.X, PSI Rev 2.X
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSI Rev 1.XDevice
PSI Rev 1.X is an older version of the PSI measurement.
PSI Rev 2.XDevice
PSI Rev 2.X is a newer version of the PSI measurement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: Device: PSI Rev 2.X |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of anesthesia to the time of Return of Consciousness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start11 Nov 2016
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Ramsay, M.D., Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954952
- Sponsor's protocol ID
- RAMS0005
- Status last verified
- Aug 2019
- First submitted
- 2 Nov 2016
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Data Collection to Evaluate New Patient State Index Performance
- ClinicalTrials.gov ID
- NCT02954952
- Acronym / sponsor ID
- RAMS0005
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care (baseline) | Other | Device: PSI Rev 1.XSubjects 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 | Experimental | Device: PSI Rev 1.XThe anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X). |
| PSI Rev 2.X | Experimental | Device: PSI Rev 2.XThe anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSI Rev 1.XPSI Rev 1.X is an older version of the PSI measurement. | Device | PSI Rev 1.X, Standard of care (baseline) |
| PSI Rev 2.XPSI Rev 2.X is a newer version of the PSI measurement. | Device | PSI Rev 2.X |
Primary outcome
Wake up Times, PSI 1.X vs. PSI 2.X
Time frame: From the end of anesthesia to the time of Return of Consciousness
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Ramsay, M.D. principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSI Rev 1.X and PSI Rev 2.X in people with Surgery, run by Masimo Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake up Times, PSI 1.X vs. PSI 2.X (time frame: From the end of anesthesia to the time of Return of Consciousness). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.