Surgery
Conditions
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.
Interventions
DEVICEPSI Rev 1.X
PSI Rev 1.X is an older version of the PSI measurement.
DEVICEPSI Rev 2.X
PSI Rev 2.X is a newer version of the PSI measurement.
Sponsors
Masimo Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wake up Times, PSI 1.X vs. PSI 2.X | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Somatic Events, PSI 1.X vs. PSI 2.X | Through study completion | Compare the frequency of somatic events between the PSI 1.X group and the PSI 2.X group. |
| Total Anesthesia Drug Used, PSI 1.X vs. PSI 2.X | Through study completion | Compare the total amount of anesthesia drug used between the PSI 1.X group and the PSI 2.X group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 5 |
| 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. | 3 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | No data collected | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Standard of Care (Baseline) | PSI Rev 1.X | PSI Rev 2.X | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 1 Participants | 2 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 4 Participants | 1 Participants | 30 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 14.3 | 55.2 years STANDARD_DEVIATION 15.5 | 67 years STANDARD_DEVIATION 2.6 | 56.5 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 27 Participants | 5 Participants | 3 Participants | 35 Participants |
| Region of Enrollment United States | 36 Participants | 5 Participants | 3 Participants | 44 Participants |
| Sex/Gender, Customized Female | 22 Participants | 4 Participants | 1 Participants | 27 Participants |
| Sex/Gender, Customized Male | 13 Participants | 1 Participants | 2 Participants | 16 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 0 / 36 | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 0 / 36 | 0 / 5 | 0 / 3 |
Outcome results
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.
Time frame: From the end of anesthesia to the time of Return of Consciousness
Population: Data were not collected.
Other Pre-specified
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.
Time frame: Through study completion
Other Pre-specified
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.
Time frame: Through study completion