After some delay due to COVID-19, we are happy to announce that the first patient was included in the Nightingale Phase 3 study at the University Medical Center Utrecht in the Netherlands.
All five sites (Utrecht, Leuven, London, Stockholm and Aachen) are planning to include at least 25 patients that are of high risk of deterioration. The Checkpoint Cardio device will be tested with patients both in the hospital and at home after discharge. We will test the accuracy and usability of the device and evaluate the warning system. The data will be evaluated retrospectively, meaning that during use of the device, both patients and involved healthcare professionals will not be aware of what the system measures. In this way the system cannot affect the clinical decision making, while its reliability is being tested.
We look forward to starting at the other sites as well.