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

Not Applicable

Terminated

• Conditions: Anesthesia
• Interventions: Device: Pediatric SedLine forehead EEG sensor

• Registration Number: NCT03128931
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-23
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2018-11-29
• Study Completion: 2018-11-29
• Results First Submitted: 2020-05-28
• Results First Submitted QC: 2020-06-23
• Results First Posted: 2020-07-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Group	Pediatric SedLine forehead EEG sensor	The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Stanford, California, United States