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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - DiaMon (Continuous Diaphragm Monitoring for mechanically ventilated patients)

Teaser

Summary

Mechanical ventilation (MV) is one of the most common interventions implemented in the intensive care unit (ICU) and more than half of the patients in the ICU are ventilated the first 24 hours after ICU admission. Conventional invasive ventilation is associated with a number of complications such as diaphragm muscle cell shrinkage and associated muscle weakness, pneumonia and damage to the lung tissue due to incorrect ventilator settings. Many of the complications increase in likelihood with duration of ventilation. Nonetheless, if a patient is decoupled from the ventilator (via a process known as â€œweaningâ€) too early they might not be ready to breathe on their own and will have to be re-intubated for an extended period of time. Studies indicate that 15% of the patients that are extubated must be put back on MV for extended treatment. Timing and adjustment of MV and of initiating the weaning process is therefore critical to ensure timely and safe recovery. In addition, ventilation in ICUs has enormous costs for healthcare systems. Incremental MV costs are estimated to be USD$1,500 (â‚¬1410) per patient per day. Subjects receiving prolonged MV in ICUs account for 6% of all ventilated patients but consume 37% of ICU resources. With an estimation of 1.35 million MV patients in the EU for an average of 4-5 days, this represents an enormous expenditure of â‚¬7.5 billion annually. In sum, it is highly important to bring patients from MV back to normal breathing as quickly as possible, while ensuring successful weaning.

The diaphragm is the most important respiratory muscle and yet, it is rarely measured during weaning, due to the complicated and personnel-intensive method of standard ultrasound imaging and low diagnostic accuracy of palpation. Further, continuous monitoring is not possible with either of these alternative techniques. DiaMon is the first ever ultrasound sensor that can stick to the skin during weaning to provide continuous, objective data in a non-invasive way to support decision making during extubation from MV.

The objectives set out in our SME phase 1 application have been achieved as described in this report. We have confirmed a clinical need, identified a clinical indication (weaning), established a business plan based on market research, commenced clinical testing and established collaborations for future validation trials. Our clinical plan has been constructed in such a way that it minimises risk of failure in the validation phase.

After successfully completing the feasibility study, we strongly believe that Respinor AS is ready to undertake the SME Instrument phase 2 project to realise our development, clinical validation and commercialisation objectives.

Work performed

The DiaMon project aims to mature, clinically validate and commercialise a small ultrasound-based sensor for accurate and continuous monitoring of diaphragm movement, in a user-friendly and operator independent manner, to support the MV treatment process.
In line with the objectives of the SME instrument phase 1 project, the focus of this project has been on delivering the following tasks:

1. Define value proposition of DiaMon with key stakeholders.
2. Develop a market study and financial risk analysis and compile it into a business plan.
3. Prepare clinical trials for Phase 2.

The outcomes from this project have led us to develop and test a feasible business model on engaging stakeholders. Weâ€™ve further initiated a clinical feasibility study and both of these outcomes have reduced the overall risks of the SME instrument phase 2 project to be submitted for consideration in January 2017.

Final results

There is currently a lack of accurate and cost-effective solutions to significantly enhance MV and reduce its duration as indicated by the growing numbers of failed/delayed extubations. Recent research has shown that ultrasound measurements can provide valuable information in the assessment and follow up of patients on mechanical ventilators. However, this technique requires expensive equipment, a skilled operator, and provides only limited and non-continuous data. DiaMon utilises the advantages of ultrasounds ability to safely and non-invasively monitor the diaphragm but also overcoming its disadvantages of the need for the presence of a skilled operator to obtain data to inform patient decision-making.

It is critical to provide optimally adjusted MV to secure a safe, efficient, and as short as possible treatment. Overextending the lungs during initial set-up can lead to lung injury. Poorly adjusted ventilation and untimely discontinuation (too soon/too late) is associated with a prolonged need for treatment and involves substantial strain on the patient and healthcare resources. The continuous monitoring of the diaphragm movement through DiaMon will significantly enhance the MV process from initiation to discontinuation.