Table of Contents
RT’s three key takeaways:
- New regulatory category: The Food and Drug Administration (FDA), with approval of Syncron-E, has established software classification for ventilation waveform analysis.
- Automated asynchrony detection: The software helps respiratory therapists identify ineffective efforts, which are the most common type of patient-ventilator discrepancy and often go undetected during manual bedside checks.
- Clinical implications: By providing a structured way to analyze recorded waveform data, the technology addresses a common problem associated with muscle injury, prolonged ventilation and difficulty weaning.
According to the company, Autonomous Healthcare received FDA De Novo marketing approval for Syncron-E, a software that helps assess patient-ventilator asynchrony by detecting evidence of ineffective efforts.
The De Novo grant introduces a new FDA device classification, ventilator waveform analysis software, making Syncron-E the first device in this category. The software is an add-on aid for respiratory therapists to analyze previously recorded ventilation waveform data from adult patients 22 years of age or older receiving invasive mechanical ventilation.
Patient-ventilator asynchrony occurs when there is a mismatch between the patient’s needs and what the ventilator is delivering. According to the company, this is a common issue in the intensive care unit that can cause patient discomfort and is associated with poorer outcomes for critically ill patients. Ineffective effort, where a patient tries to breathe but the ventilator fails to deliver a supportive breath, is the most common type of asynchrony.
Published research shows that these efforts can affect nearly half of ventilated patients and are associated with inspiratory muscle injuries, prolonged time on the ventilator and difficulty weaning, the release said. Because these events occur intermittently and can be subtle, they are often missed during manual bedside waveform reviews.
Syncron-E analyzes previously recorded ventilation waveforms and summarizes the results for a respiratory therapist to review. This replaces a manual task with a structured, automated method of identifying evidence of ineffective efforts.
“This FDA de novo grant is a milestone in development and a pivotal moment for Autonomous Healthcare,” said Behnood Gholami, PhD, co-founder and CEO of Autonomous Healthcare. “We took the harder route and created a new category of devices because clinicians need tools that simply didn’t exist before.”
The software is now marketed in the USA as a Class II medical device.
“Asynchrony is a very common problem in the ICU. However, because it occurs sporadically and respiratory therapists care for many patients at the same time, it often goes undetected. Detection is the first step in addressing clinical problems, and we believe Syncron-E will help change that,” said James M. Bailey, MD, PhD, Chief Medical Officer of Autonomous Healthcare.
https://respiratory-therapy.com/products-treatment/industry-regulatory-news/fda-approvals/fda-syncron-e-patient-ventilator-asynchrony/
