Optimizing weaning from mechanical ventilation with RESPINOR DXT

RESPINOR is developing a novel non-invasive medical device, DXT (Diaphragm Excursion Technology), to improve clinical decision-making in critically ill patients in the Intensive Care Unit (ICU). DXT has the first ultrasound sensors that can stick to the skin to provide continuous monitoring of our main breathing muscle. RESPINOR has successfully finalized clinical feasibility studies in France and Norway, for the first target segment, mechanical ventilation (MV). These studies demonstrated that patients who failed to be weaned from the ventilator had a lower diaphragm excursion compared to patients who were successfully weaned, meaning DXT can identify if the diaphragm is strong enough to ensure the patient are successfully taken off the ventilator. We identified a cut-off value of 1.1 cm, confirming proof of concept regarding weaning success. Our ambition is to become the next vital sign for assessing work of breathing. Every day a patient receives MV, the risk of permanent impairment to the breathing ability increases along with the treatment costs. It is important to bring patients off MV and back to spontaneous breathing as quickly as possible. The process of withdrawing ventilatory support is known as weaning. DXT will be the first in kind to provide objective, accurate, non-invasive, continuous monitoring of the diaphragm to support the weaning process. The diaphragm is our main breathing muscle, and accounts for 70% of the air we breathe in. During MV, patients experience significant weakening of the diaphragm already after one day. Weaning failure can be directly linked with diaphragm dysfunction but monitoring of the diaphragm is not routinely performed. Up to 30% of patients are reintubated after disconnecting from MV, and reintubation is associated with severe risk. Hence, diaphragm dysfunction is often underdiagnosed. With DXT we aim to improve clinical decision-making in critically ill patients, with non-invasive technology, measuring the diaphragm movement and providing real-time continuous feedback with an easy-to-use technology. The project goal was to develop predictive indices to optimize time on MV by establishing cut-off values to predict weaning outcome. This to ensure patients are liberated from the ventilator at the right time when the diaphragm is strong enough to enable patients to breathe by themselves. Through a successful project, DXT has the potential to optimize extubation timing, reduce re-intubation rate, improve patient outcomes, and thereby reduce healthcare costs. The project consortium consisted of RESPINOR and two academic partners: Hôpitaux Universitaires Pité Salpêtrière in France; and Oslo University Hospital, Rikshospitalet, Norway. The DE-RISK WF study started according to plan with first ethics committee approval in Q1 2021, and first patient included in April 2021 at Rikshospitalet. The last patient was included according to plan in Q1 (16. March) 2022. In total, 193 patients were included in the clinical study. The financial milestone was completed with a private placement of 20 million NOK in September 2021. All planned project activities were completed on time and on budget. However, analysis of the clinical data according to the study protocol showed that the study did not meet the primary endpoint. Retrospective analysis of the data revealed unanticipated user errors, causing poor signal quality with DXT. By adjusting for this in the analysis, it became clear that the primary endpoint could have been met. RESPINOR identified the root causes and implemented several improvements to improve the usability of DXT. To demonstrate that these improvements were successful, RESPINOR has in collaboration with the hospitals that participated in the DE-RISK WF study, started a new project, and a new clinical study (DE-RISK WF II) that will include 145 patients. In this study, all hospitals had to include 3 "run-in" patients each to demonstrate that the changes to the DXT, produced good signal quality before including patients in the study. The 7 hospitals have included a total of 21 run-in patients, and the signal quality was found to be acceptable in all of these patients, demonstrating that the implemented improvements of the DXT were highly successful. The DE-RISK WF II study is estimated to be completed in Q2 2023. After this, RESPINOR will file for CE mark and FDA approval. After implementing all improvements to DXT and the start of the DE-RISK WF II study, the partner hospitals have expressed strong customer satisfaction with DXT and highlight the user friendliness of the device.

RESPINOR is developing a novel, non-invasive, ultrasound based medical technology, DXT (Diaphragm Excursion Technology), that provides real-time, continuous monitoring (of respiratory rate and diaphragm excursion), to improve clinical decision-making in critically ill patients in the ICU. 2,1 million patients per year require mechanical ventilation (MV) across the EU and the US, and there is a significant medical need to improve the weaning process. If patients are too long on MV, they risk major damage to the diaphragm and the long-term prognosis is severe. 65% of surviving patients on prolonged MV are completely dependent on help with activities of daily living 1 year after treatment. However, if patients are extubated too early, they need to be reintubated. The risks associated with reintubation are serious, including increased mortality. Today, up to 30% of patients are reintubated, and after 1 year, 25-50% of these patients are deceased. Moreover, these patients account for 3% of hospital patients, but 12% of all hospital costs. Incremental cost per patient on MV is estimated to €1617 per day and with an average of 4,8 days, this represents an expenditure of at least €15 billion annually. Hence, for every extra day a patient stays on MV, the risk of permanent impairment to the breathing ability increases along with treatment costs. It is therefore highly important to bring patients off MV and back to spontaneous breathing as quickly as possible. Yet today there are no standardized and objective technologies for continuous monitoring of the diaphragm available. The literature has documented that monitoring of the diaphragm can reduce time on MV by 25%. Furthermore, reducing time on MV with 1 day for 10% of patients, represent a potential cost saving of 340 mill EUR yearly. This project has addressed these socioeconomic needs, and delivers a novel monitoring medical technology that aid the better decision making for patients on MV. Specialists at hospitals will get access to an easy to use technology, with high accuracy for predicting weaning outcome with a well established threshold. The project resulted in a significantly improved DXT product, from a prototype to a close to commercial version. Furthermore, we developed a new DXT tape kit which resulted in a patent application. During this project data from 193 patients were collected in the DE-RISK WF study which enabled RESPINOR to improve the usability of DXT significantly.

RESPINOR is developing a novel, non-invasive, ultrasound based medical device, DXT (Diaphragm Excursion Technology), that provides real-time, continuous monitoring of respiratory rate and diaphragm excursion. DXT has a broad range of potential benefits and represents an enabling technology platform for applications in critical care and other areas of respiratory medicine. DXT is the first ever ultrasound sensor that can stick to the skin to provide continuous monitoring. RESPINOR has successfully finalized clinical feasibility studies in Europe for the first target segment, Mechanical Ventilation (MV), with technical proof of principle and proof of concept confirmed. MV is one of the most common therapies in the intensive care unit (ICU). It is a vital support for patients, but not a risk-free intervention. The transition from MV back to spontaneous breathing is undertaken via a process known as “weaning” and involves decreasing the level of support from the ventilator. Deciding the correct time of weaning from MV is critical as delayed weaning and extubation are associated with longer ICU stay, increased morbidity and mortality. However, 20-30% remains ventilator-dependent for prolonged periods, and extubation failure has been as high as 30% is some studies. Consequently, there is a need for technologies to better predict weaning from mechanical ventilation to optimize time for extubation. The project goal is to develop predictive indices to optimize time on MV by establishing cut-off values to predict weaning outcome. Through a successful project, DXT has the potential to optimize extubation timing, reduce re-intubation rate, improve patient outcomes, and reduce healthcare costs. The project consortium consists of RESPINOR and two academic partners: Hôpitaux Universitaires Pité Salpêtrière, the largest hospital in France; and Oslo University Hospital, Rikshospitalet, Norway, with special assignments in research and the development of new methods of treatment.