Study Stopped
Study was terminated as enrollment rate did not meet the requirement of the Sponsor.
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2018
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedApril 7, 2022
April 1, 2022
1.9 years
April 14, 2017
May 28, 2020
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Test Group
EXPERIMENTALThe subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucille Packard Children's Hospital
Stanford, California, 94305, United States
Results Point of Contact
- Title
- Vikram Ramakanth
- Organization
- Masimo Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 25, 2017
Study Start
December 23, 2016
Primary Completion
November 29, 2018
Study Completion
November 29, 2018
Last Updated
April 7, 2022
Results First Posted
July 7, 2020
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share