Every 10th newborn baby is a premature birth, worldwide. Progress in the care of very immature premature babies has led to a rate of healthy survival of over 90% today, compared to marginal survival rates 40 years ago. One of the key building blocks has been the improvement of ventilation. Studies have shown that ventilation triggered by self-breathing leads to significantly better long-term results than ventilation modes used in the past. In order to further increase the rate of healthy survival, it is therefore necessary to further develop ventilation in such a way that the ventilator is triggered by the child's own breathing using an easy-to-use sensor system.
The goal of smartNIV is the development of an intelligent non-invasive ventilation system for premature infants, which is controlled by a highly elastic multi-sensor patch. This patch is applied to the skin at the transition between chest and abdomen to measure the typical deformations of the thorax caused by breathing and to provide the ventilator with a control signal.
The multi-sensor concept offers the advantage that the failure of even several sensors does not lead to the failure of the entire system. In addition, the flat patch is intended to increase the tolerance against positional inaccuracies to such an extent that simple but reliable application by medical personnel is guaranteed. Furthermore, the patch can be easily resized and is therefore also suitable for very small premature babies. In addition to the novel, highly elastic sensor hardware, the innovation lies in the evaluation software based on artificial intelligence, which will adapt automatically and in real time to the ventilation situation. Conventional systems are hard-coded and therefore very susceptible to interference compared to e.g. unexpected child movements.
All in all, this new medical technology should not only enable triggered respiratory support, but also the recording of the entire respiratory curve, i.e. not only the beginning of inhalation, but also the beginning of exhalation and the intensity of the breathing effort in between. For the first time ever, non-invasive, gentle ventilation would be able to support the breathing effort of a premature infant to the nearest millisecond, which is currently only available for invasive ventilation. It is expected that this will not only relieve the financial burden on the healthcare system, but will also give premature and newborn babies significantly better chances of surviving healthy.
In order to exploit the results, the project consortium aims at a downstream development of the demonstrator into an approved medical device. The supply of the hardware and software as well as the final production and marketing of the entire system should be handled within the consortium.
Project period: 07/2020 – 12/2022
Funding organization: BMBF
Project responsible: Eugen Koch