FDA-Cleared Index Enables Pediatric-Specific Sedation Monitoring

In perioperative and intensive care settings, inaccurate assessment can increase the risk of oversedation and postoperative complications, underscoring the need for age-appropriate monitoring. A newly cleared index now offers a pediatric‑specific approach to sedation scoring, designed around the unique physiology of the developing brain.

Masimo, a Danaher company, has announced that the Patient State Index (PSi) for pediatric patients has received U.S. Food and Drug Administration (FDA) 510(k) clearance as the first and only sedation score specifically designed for the unique physiology of the pediatric brain. Pediatric PSi is a feature of the Masimo SedLine brain function monitoring platform and is intended to help clinicians monitor depth of sedation in children aged four years and older in the operating room and intensive care unit. It is also the only index indicated for pediatric use with both propofol and sevoflurane.

SedLine processes and displays electroencephalogram (EEG) signals from both hemispheres, along with a multi-taper Density Spectral Array (DSA) and PSi, a proprietary computed EEG variable. The pediatric PSi algorithm is specifically calibrated and validated for children and, like the adult PSi, is derived from bilateral brain data. The index can be trended and incorporated into the electronic medical record (EMR) to support perioperative documentation.

In the United States, SedLine brain function monitoring is indicated for adults and for children one year and older, while the PSi feature is indicated for children four years and older. Pediatric SedLine was first cleared by the FDA in 2022. For the latest clearance, researchers submitted clinical data from 169 pediatric patients showing that pediatric PSi scores were responsive and well correlated with manually scored stages of anesthesia and with episodes of burst suppression, a sign of potential oversedation. A comparison with published data evaluating a competing technology not calibrated for pediatric brains confirmed pediatric PSi’s superior performance.

“The risks of oversedating pediatric brains are significant. Their fragility makes it harder to achieve and maintain appropriate levels of sedation and also increases the chances that oversedation will lead to postoperative complications. Sedating children using standard‑of‑care dosing guidelines without depth of sedation monitoring is risky – and so too is a one‑size‑fits‑all approach to index‑based monitoring,” said Professor Zaccaria Ricci, MD, Director of Anesthesiology and the PICU at Meyer Children’s Hospital and Associate Professor in the Department of Health Science at the University of Florence, Italy.

"In Europe, where pediatric SedLine monitoring with the PSi has been available for several years, we have found the index particularly useful in helping us optimize depth of sedation in children and believe it adds significant value to our pediatric anesthesia practices. From a practical perspective, the PSi is also helpful because without it, it’s difficult to trend and record brain function data in patient charts, since you cannot trend DSA or raw EEG data," added Dr. Ricci.