Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock

Overview

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 physiological monitoring system. It consists of a sensor patch with multiple red and near-infrared light sources and detectors (NIRS and PPG), a pre-applied medical-grade adhesive, an ECG/ICG sensor patch, and a display unit (tablet running the NIRSense application) that receives data over Bluetooth and stores it. The sensor estimates StO2 in microvascular tissue up to about 2.5 cm below the skin and derives PPG-based metrics including pulse rate, respiratory rate, and perfusion index. The device has not been cleared or approved by the U.S. FDA. Design: Prospective data collection, single-center observational study. Two populations are targeted: (1) patients with acute myocardial infarction, with or without shock (SCAI B to D), admitted for coronary angiography and subsequent interventions, and (2) patients with acute decompensated heart failure admitted for pulmonary artery catheter insertion and subsequent interventions. Participants are enrolled from the existing Cleveland Clinic Florida patient population in a way that avoids disruption of clinical workflow. After informed consent, sensors are placed on the sternum, forearm, and other locations according to manufacturer specifications and remain in place while the patient is in the cardiac intensive care unit, for approximately 24 to 72 hours. Sensors may be repositioned during catheterization or imaging at the investigator's discretion. Participation is limited to the single standard-of-care admission; there is no study follow-up visit or call. Data collected: Continuous sensor data (StO2, SpO2, pulse rate, respiratory rate, ECG/ICG-derived stroke volume, PPG-derived metrics) and sensor placement images. Data collected during standard-of-care treatment and shared with the sponsor: demographics, Fitzpatrick skin type, medical history, concomitant medications, physical examination, vital signs, a single 12-lead ECG, blood pressure, heart rate, cardiac output (thermodilution) where obtained, clinically ordered lactate values, SCAI stage, and clinical course. Adverse events and device deficiencies are recorded from enrollment through sensor removal. Clinical staff complete a usability survey after using the device on 5 patients. Analysis: Descriptive statistics for demographics and baseline characteristics; adverse events summarized by frequency and percentage, severity, and device relatedness. Effectiveness analyses use all evaluable data and compare device measurements with standard-of-care hemodynamic parameters and with SCAI stage trajectory, as specified in the Statistical Analysis Plan. Following an interim analysis of the 20-patient pilot, enrollment may be expanded to 200 patients under a protocol amendment; that expansion is not part of this record.