Anesthesia
Conditions
Brief summary
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
Interventions
DEVICEPediatric SedLine forehead EEG sensor
Pediatric EEG sensor.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients 17 years old and younger * ASA status I, II, or III. * Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic).
Exclusion criteria
* Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit. * Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions). * Subjects who are developmentally delayed. * Subjects deemed not suitable for study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants For Whom the EEG Data Collection Was Completed | Duration of surgery | EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .
Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment Issues | 3 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Test Group |
|---|---|
| Age, Categorical <=18 years | 41 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Number of Participants For Whom the EEG Data Collection Was Completed
EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
Time frame: Duration of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Group | Number of Participants For Whom the EEG Data Collection Was Completed | 41 Participants |