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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03128931
• Other study ID #: HAMM0001
• Status: Terminated
• Phase: N/A
• Start date: December 23, 2016
• Est. completion date: November 29, 2018

Study information

• Verified date: April 2022
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Pediatric SedLine forehead EEG sensor
Pediatric EEG sensor.

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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