PRODUCT · MECHANICAL VENTILATION

Syncron-E™

Waveform intelligence for mechanical ventilation.

FDA De Novo Authorization

THE PROBLEM

Asynchrony is common, harmful, and mostly invisible.

Detecting it depends on a clinician being at the bedside at the right moment, reading subtle waveform patterns. In a busy ICU, most events go unseen.

ASSOCIATED WITH

Longer time on ventilation

ASSOCIATED WITH

Extended ICU stays

ASSOCIATED WITH

Increased mortality

THE SOLUTION

Every breath analyzed. Every event scored.

Syncron-E analyzes pressure and flow waveforms breath by breath, flagging ineffective effort, the most frequent type of patient-ventilator asynchrony, for the respiratory therapist to review.

PEER-REVIEWED RESEARCH

Syncron-E draws on years of peer-reviewed research in ventilator waveform analysis.

Validation of an automated system for detecting ineffective triggering asynchronies during mechanical ventilation

Phan TS et al. (2020)

Journal of Clinical Monitoring and Computing

Replicating human expertise of mechanical ventilation waveform analysis in detecting patient-ventilator cycling asynchrony using machine learning

Gholami B et al. (2018)

Computers in Biology and Medicine

INTENDED USE

Syncron-E is an adjunctive aid intended for respiratory therapists to analyze previously recorded ventilator waveform data from adult patients 22 years and older receiving invasive mechanical ventilation, to detect evidence of ineffective effort. It is not intended for use in time-sensitive scenarios and does not replace clinical judgment.

Syncron-E is authorized for marketing in the U.S. through the FDA De Novo classification process as a Class II medical device. Caution: Federal law restricts this device to sale by or on the order of a physician.

Syncron-E™ is the first FDA-authorized system for detecting the most frequent type of patient-ventilator asynchrony called ineffective effort.

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