Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis

Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis

The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the prediction of sepsis onset in ICU patients at risk of developing sepsis. Patients will be monitored for up to 48 hours, and the collected physiological and biomarker data will be used to support the development of artificial intelligence and machine learning models for sepsis prediction.

This is a prospective clinical performance study involving ICU patients at risk of developing sepsis. The study will assess the integration of portable sensor devices into the CPC telemonitoring platform for the collection and visualization of physiological and biomarker data.

The CPC12S device will collect vital physiological parameters, including electrocardiography, oxygen saturation, non-invasive blood pressure, respiratory rate, heart rate, body position, and physical activity. A CPC temperature and humidity sensor will be used for continuous monitoring of body temperature and humidity. In addition, the IDRO investigational sweat lactate sensor will be integrated into the system to collect sweat lactate data.

The study will be conducted in phases. In the first phase, patients will be monitored using the CPC12S device together with the temperature and humidity sensor. In the second phase, patients will be monitored using the CPC system, the temperature and humidity sensor, and the IDRO sweat lactate sensor.

All patients will be monitored for up to 48 hours. The collected data will be analyzed together with clinical information recorded by healthcare professionals. The primary objective is to support prediction of sepsis onset by integrating data from the CPC12S device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor. Secondary objectives include completing the integration of the IDRO sensor into the CPC system, validating the IDRO sweat lactate measurements against standard clinical blood lactate measurements, and developing an algorithm based on device-recorded and clinical data for sepsis prediction.

The data collected in this study will not be used to guide clinical decisions during the study. Medical care and clinical decisions will remain under the responsibility of the hospital medical team according to standard clinical practice.

Inclusion Criteria:

• Adult patients aged 18 years or older.
• Patients admitted to the intensive care unit who are at risk of developing sepsis.
• Patients with one or more relevant risk factors for sepsis, including pre-existing medical conditions, invasive medical devices, recent procedures or conditions, active infections, clinical risk factors, or prolonged ICU/hospital stay.
• Signed informed consent.Exclusion Criteria:
• Inability or unwillingness to provide informed consent or comply with study requirements.
• ICU stay shorter than 6 hours.
• Damaged tattoos, bare skin, recent scar tissue, inflammation, infection, skin barrier alteration, serous or bloody discharge, or metal plates/nails at the area where the Macroduct Advanced system and IDRO device will be placed.
• Patients admitted to the ICU with already diagnosed sepsis.
• Patients participating in other clinical studies.
• Moribund patients or patients with very short life expectancy.
• Patients with do-not-resuscitate status at admission.
• Patients with implanted devices such as an implanted defibrillator, implanted neurostimulator, implanted pacemaker, or implanted ECG monitor.
• Patients in whom short-term interference between the Macroduct device and clinical monitoring cannot be accepted.
• Patients with a history of epilepsy or seizures.
• Pregnant patients or patients who may be pregnant.
• Patients with previous adverse reactions to electrotherapy.
• Patients who present adverse reactions during the first sampling with the Macroduct device.
• Patients for whom the procedure is contraindicated for medical reasons according to the physician's decision.
• Patients with known sensitivity or allergy to pilocarpine nitrate, or any medical contraindication to pilocarpine administration.
• Patients in environments with flammable anesthetics or oxygen-enriched environments.