NIRSense Inc.
This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and photoplethysmography (PPG), combined with an electrocardiography/impedance cardiography (ECG/ICG) sensor, to continuously monitor tissue oxygen saturation (StO2), peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, stroke volume, and related metrics. Up to 20 adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction or acute decompensated heart failure and in Society for Cardiovascular Angiography and Interventions (SCAI) shock stage B, C, or D will wear the sensors on the sternum, forearm, and other locations for approximately 24 to 72 hours during standard care. Sensor data will be compared with standard-of-care hemodynamic and laboratory measurements and with the patient's clinical course to evaluate the feasibility of the device, the correlation of its measurements with established clinical parameters, and its potential to detect deterioration in SCAI shock stage earlier. No treatment decisions are made based on the study device.
Background: Cardiogenic shock (CS) carries a poor prognosis and is the leading cause of death in patients with acute myocardial infarction. When decompensation occurs there is an imperative to institute treatment rapidly. Standard intensive care unit monitoring relies on intermittent hemodynamic and laboratory measures. Continuous, noninvasive measurement of tissue perfusion and oxygenation could allow earlier recognition of deterioration and earlier intervention. Device: The NIRSense Tissue Oximetry Sensor System is an investigational, non-significant-risk, noninvasive wearable optical physi…
Inclusion Criteria: * Acutely decompensated symptomatic heart failure (HF) documented by: (a) symptoms of HF requiring current treatment; (b) Society for Cardiovascular Angiography and Interventions (SCAI) stage B, C, or D; and (c) hospital admission with HF as the primary or secondary diagnosis; OR acute myocardial infarction (MI) patient undergoing coronary angiography * Admitted to the intensive care unit and currently in SCAI stage B, C, or D * Age 18 years or older * Weight greater than 40 kg Exclusion Criteria: * Prior known severe allergy to medical-grade adhesive or tape (self-repor…
Investigational noninvasive wearable sensor patches using near-infrared spectroscopy and photoplethysmography to continuously measure tissue oxygen saturation, SpO2, pulse rate, respiratory rate, and perfusion index, plus an ECG/ICG sensor patch for stroke volume, with a tablet display and recording application. Sensors are applied to the sternum, forearm, and other locations with a medical-grade adhesive and worn for approximately 24 to 72 hours during standard cardiac ICU care. Sensor data are collected for research only and are not used for treatment decisions.