Study title: Continuous measurement of diaphragm excursion as a predictor of extubation failure

The primary objective of this study is to compare diaphragm excursion values obtained around a 30- minute spontaneous breathing trial (SBT) using RESPINOR DXT in patients who are successfully and unsuccessfully weaned.

We expect this study to gain new valuable knowledge about spontaneous diaphragm activity during weaning from mechanical ventilation support and show that our device will offer a valuable tool to identify the optimal time for weaning and disconnection from the ventilator.

This study is observational and is the first use of RESPINOR DXT within the intensive care population. Similar observational studies with different objectives are planned to commence in Paris, Angers, and Lyon in April 2019. The data will be used to provide clinical evidence to support the development of protocols for further studies that will define specific patient benefits.

RESPINOR AS: A Norwegian medical device company founded in 2015 based on IP, prototypes and clinical development at the University of Oslo and NeoRad AS. RESPINOR is developing an objective measure of breathing for critically ill patients within intensive care. RESPINOR DXT (Diaphragm Excursion Technology) is non-invasive, easy to use and provides precise, real-time continuous monitoring of the diaphragm function, our main breathing muscle. Monitoring the up-and-down movement of the liver, RESPINOR DXT measures diaphragm excursion using the liver as a proxy for the motion of the diaphragm. The monitoring of the diaphragm may provide useful information to guide clinical decision making in patients with respiratory dysfunction. RESPINOR DXT was twice ranked number one in the European Commission’s Horizon 2020 program, both in phase I and phase II, addressing an unmet medical need because every breath counts.

Currently, the company has initiated clinical observational studies in Europe (Norway, France, and Italy), which will lead to a multinational multicenter study for the first indication in mechanical ventilation (MV).

RESPINOR’s technology has a broad range of potential benefits and represents an enabling technology platform for application in critical care and other areas of respiratory medicine.

Mechanical ventilation (MV): Patients are placed on invasive MV because they are unable to sustain breathing on their own in such a way as to maintain sufficient gas exchange (oxygen uptake, carbon dioxide elimination). The most common underlying clinical conditions that are associated with acute respiratory failure and the subsequent need for MV include postoperative respiratory failure, neurologic disease, pneumonia, chronic obstructive pulmonary disorder (COPD), congestive heart failure, and sepsis.

However, MV is associated with a number of complications including muscle atrophy (shrinkage due to underuse) and muscle fiber damage related to increases in protein breakdown caused by unloading of the diaphragm as the ventilator assumes control of respiration, pneumonia, and lung injury due to excessive pressure or volume of air forced into the lungs by the ventilator. The process of diaphragm muscle fiber damage and atrophy has been shown to begin as soon as within 3-4 days of commencing MV.

As such, the intensive care clinician must balance the need for MV to maintain adequate gas exchange with getting the patient off the ventilator as soon as possible (a process known as “weaning”) so as to avoid diaphragm dysfunction.

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