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

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 Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Device: Pediatric SedLine forehead EEG sensor

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Lucille Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor.	Device: Pediatric SedLine forehead EEG sensor; Pediatric EEG sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Duration of surgery

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2016
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HAMM0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes