Anesthesia
Conditions
Brief summary
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
Interventions
DEVICESedLine Vs Comparator Test Group
Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years old and older at the time of consent. * ASA status I, II, or III. * English-speaking subjects. * Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
Exclusion criteria
* Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit. * Subjects who are developmentally delayed. * Subjects deemed not suitable for study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Sedation Indices Performance Across Anesthesia Range | Duration of surgery | The correlation was computed using 1 min average values between the PSi and the comparator's sedation index. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SedLine Vs Comparator Test Group SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment failure | 4 |
| Overall Study | Procedure Cancelled | 4 |
Baseline characteristics
| Characteristic | SedLine Vs Comparator Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Race/Ethnicity, Customized African American | 5 participants |
| Race/Ethnicity, Customized American Indian | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Not reported | 14 participants |
| Race/Ethnicity, Customized Other | 5 participants |
| Race/Ethnicity, Customized White | 74 participants |
| Region of Enrollment United States | 100 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 1 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Correlation of Sedation Indices Performance Across Anesthesia Range
The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.
Time frame: Duration of surgery
Population: Due to the complexity of data collection, complete data for analysis was available from 61 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SedLine Vs Comparator Test Group | Correlation of Sedation Indices Performance Across Anesthesia Range | 0.8314 Pearson r |