Results from clinical evidence studies confirm the ability of RESPINOR DXT to identify patients at increased risk of extubation failure.

RESPINOR has successfully completed the clinical evidence program for the first indication, weaning from mechanical ventilation (MV), and is now preparing for regulatory submission both in Europe and the US.

Two prospective, multinational, multicenter, blinded clinical studies, DE-RISK WF, and DE-RISK WF II, were performed with DXT at 8 hospitals in France and Norway.

A total of 338 patients were included in the studies, whereas 191 patients were extubated (intention to treat population). The results demonstrated that DXT can identify patients at increased risk of extubation failure with a relative risk of 8.2 (95% CI 1.9-35.1, p=0.004). This means that patients who have a diaphragm excursion below the predefined threshold of 1.1 cm have 8 times higher risk of reintubation. No adverse device effects were observed.

• By detecting patients at increased risk of post-extubation acute respiratory failure, DXT can contribute to reducing the number of reintubations and thereby the risk of severe complications.
• This will result in improved patient outcomes and a lower resource burden for healthcare professionals and payers.

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“There are currently no value markers that can reliably predict extubation failure - not even good clinical sense.”

Lead Primary Investigator, Prof. Alexandre Demoule La Pitié-Salpêtrière Hospital, Paris

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With these positive results, RESPINOR is preparing for submission for CE-mark and FDA approval, to ensure that DXT will be available for critically ill patients.

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