Evaluation of SEDline EEG monitoring in pediatric patients undergoing General Anesthesia or sedation
Study ID: STU 122014-039
We intend to collect high resolution eeG data using a SeDLine and o3 modules respectively in pediatric patients and over a wide range of anesthetics, as described in the clinical protocol. in addition, we may collect similar data for inpatient subjects in the newborn intensive Care unit (niCu). For oR subjects, in order to assess the impact of anesthetic drug administration on vital sign parameters routinely used during anesthesia, we intend to collect other noninvasive parametric data including blood pressure, temperature, oxygen saturation and respiratory rate. Blood pressure and temperature will be recorded from the hospital's standard of care devices, while oxygen saturation and respiratory rate will be collected using Masimo Rainbow[RegisteredTM] Pulse Co-oximeter devices. Masimo Rainbow[RegisteredTM] is a noninvasive monitoring platform enabling the assessment of a wide range of blood constituents and physiologic parameters such as total hemoglobin (SpHb), oxygen Saturation (Spo2), Pulse Rate (PR), Perfusion index (Pi). Raw and processed physiological data will be analyzed by Masimo engineering team. Data from this study may be used to create, update and verify that the Patient State index (PSi) algorithm is appropriate for monitoring pediatric patients undergoing anesthesia with a wide variety of anesthetics used in surgical and non-surgical procedures.
Surgical and non-surgical procedures scheduled under General Anesthesia or sedation: * Pediatric patients under 18 who are classified as ASA status I, II, or III * Surgical and non-surgical procedures scheduled under General Anesthesia or sedation (Common procedures include but not restricted to tonsillectomy adenoidectomy, urological procedures, dental rehabilitation, orthopaedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, and colonoscopy. Surgery can be open, laparoscopic, or robotic). Neonates and infants in the NICU for monitoring but not scheduled for surgery: * Neonates and infants who are in the NICU for monitoring but not scheduled for surgery.
To collect o3 cerebral oximetry data, SeDLine eeG, and PSi (patient state index) data along with head size measurements, vital signs, patient demographic, and surgical procedure data during general anesthesia or sedation and/or under monitoring in the niCu.