E!11964 Wireless and miniaturized skin conductance sensors to assess pain, nerve block and patient outcome

A new publication for the "NerveBlockSensor" project has been published in 2020, by Dr. Semih Gungor, who leads the validation study for Painsensor applied to nerve blocks. The study is published in the Brazilian Journal of Anaesthesia. The New Pain Sensor has been developed by Cubist, our Swedish industrial partner in the consortium, via a wireless interface with the Masimo, Philips and Mindray patient monitors. The production line for prototypes for the Pain sensor has been established in 2020 by our subcontractor Senetics AG, Germany and the certification of the sensor will benn handled by Intertek in Nurenberg and this work is concluded autumn 2021. 3 Prototypes have been produced and delivered Med-Storm for clinical trials. The Intervention center in Oslo and the Medical Technical Department at Rikshospitalet, will perform safety tests before the prototypes are tested in clinically.Now 26 demo devices have been distributed to international partners. The sale mainly in Europe started in 2022..

Prosjektet har bidratt til både vitenskapelig klinisk samarbeid samt redesign og tilpasning mot kliniske behov. Dette hadde ikke vært mulig uten denne delfinansiering. Spesielt nyttig var det å knytte forpliktende samarbeid med Europeiske fagmiljø, da vi anser EU markedet som vårt hjemmemarked grunnet regulatoriske forhold.

To improve mobilization, decrease pain and opioid use, and predict patient outcome, novel IP-protected miniaturized and wireless CE-certified skin conductance sensors (Sensors) consisting of a rechargeable unit and disposable electrodes with new IP-protected clinical applications will be developed, and connected to Isansys' ICT platform and Windows programs. Isansys has already wireless and wearable sensors for other vital signs than pain (heart rate, blood pressure, respiratory rate and temperature). The Sensors will be used to assess pain " PainSensor", to assess regional nerve block, to improve pain management and to reduce opioid use, " NerveBlockSensor", and to predict and improve patient outcome by assessing autonomous responses, " SkinConductanceActivitySensor". Two channel sensors system and a non-existing miniaturized, wireless and wearable nerve stimulator will be developed to assess and secure nerve activity in the unblocked extremity when comparing to the blocked extremity. During general anaesthesia the nerve stimulator will be used as a neuromuscular transmission monitor (TOF Guard). Three clinical studies will be performed to validate the Sensors, test customers in the different markets, and to develop the new clinical applications with IP-rights: 1. Sean Cochelenbergh MD at the Université Libre de Bruxelles will use NerveStimulatorSensor and the PainSensor during opioid free general anaesthesia and opioid reduced postoperative analgesia to reduce length of hospital stay and the side effects of opioids. 2. Prof. Gungor. MD. Head of Pain Clinic, Hospital for Special Surgery, will use the NerveBlockSensor to assess the duration of nerve blocks in chronic pain patients in the home market to improve pain management. 3. Prof. Menon, University of Cambridge, Addenbrookes hospital and Prof. Nelson, Karolinska University hospital will predict patient outcome after traumatic brain injury using the SkinConductanceActivitySensor to improve individual tailored treatment.