The novelty of the device lies in the usage of a small ultrasound transducer in a highly specialized probe design that can be fixed to the skin surface using a patented, disposable, adhesive solution. The device is easy to use and allows for continuous monitoring of diaphragm excursion and respiratory rate. Nineteen units of the clinical prototype have been manufactured and clinical testing has been ongoing since September 2016.
Using these prototype units our clinical program continues with a set of observational studies throughout 2017. By the end of 2017, we will have developed a CE-marked product to be used in the H2020 funded randomized clinical trial starting in 2018.
The diaphragm is the main muscle of breathing, contributing to 70-75% of the volume of air brought into the lungs in a single breath in normal, healthy people. As such, respiratory problems and failure can be directly linked with diaphragm dysfunction. However, monitoring of the diaphragm is not routinely performed meaning that diaphragm dysfunction is mostly under-recognized.
Our first target application will be patients in the intensive care unit (ICU) under mechanical ventilation (MV), and more specifically for assessing the patient during the weaning process when the breathing tube is removed.
There is currently a severe lack of accurate and cost-effective solutions to support the weaning process. Recent research has shown that ultrasound measurements of diaphragm motion during MV can provide valuable information in the assessment and follow up of patients. However, this technique requires specialized equipment, a skilled operator, and provides only limited and non-continuous data. Respinor aims to fill this gap by demonstrating and commercializing a cost-effective and user friendly ultrasound device that will effectively support the weaning process.
Being a platform technology, clinical evidence of application in additional medical diagnostic groups will be pursued in the future.
- Technical development of prototype unit completed
- Development of first commercial unit in progress
- Verification testing in healthy and a pulmonary patient group completed
- Observational studies in critical care patients being undertaken in 2107/2018
- Randomised trial in weaning to be performed in 2018/2019
- Respinor has established a QA system following ISO 13485
I've been skeptical of the use of ultrasound [in weaning] because it is not useful as a monitoring device. However, you have made it a potential monitoring deviceKey opinion leader 1