SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation

Masimo Corporation45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anesthesia

Interventions

Pediatric SedLine forehead EEG sensorDEVICE

Pediatric EEG sensor.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lucille Packard Children's Hospital

Stanford, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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