SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
NCT03128931 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2022-04-07
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.
Conditions
- Anesthesia
Interventions
- DEVICE
-
Pediatric SedLine forehead EEG sensor
Pediatric EEG sensor.
Sponsors & Collaborators
-
Masimo Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Months
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-23
- Primary Completion
- 2018-11-29
- Completion
- 2018-11-29
- FDA Device
- Yes
Countries
- United States
Study Locations
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