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

Masimo

Status: Terminated

Conditions: Anesthesia

Treatments: Device: Pediatric SedLine forehead EEG sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03128931

HAMM0001

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 12 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Test Group

Experimental group

Description:

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

Treatment:

Device: Pediatric SedLine forehead EEG sensor