Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNIRSense Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior known severe allergy to medical-grade adhesive or tape (self-reported)
Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational.
The investigator believes the participant is not an appropriate candidate for the study
Trial population
Adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction undergoing coronary angiography, or with acutely decompensated heart failure, who are in SCAI shock stage B, C, or D. Participants are recruited from the existing patient population of the recruitment site.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NIRSense Tissue Oximetry Sensor System
DeviceInvestigational 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Acute myocardial infarction1 intervention
Group B: Acute decompensated heart failure1 intervention
Trial outcomes
Primary outcomes
1
Correlation between NIRSense sensor measurements and standard-of-care hemodynamic parameters
Correlation coefficients (Pearson and Spearman) between time-matched NIRSense measurements (tissue oxygen saturation, perfusion index, SpO2, pulse rate, respiratory rate, ICG-derived stroke volume) and standard-of-care clinical measurements (arterial blood pressure, heart rate, pulmonary artery and central venous pressures where a pulmonary artery catheter is present, cardiac output by thermodilution, and lactate).
Time frame
Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor applicationSecondary outcomes
1
Feasibility: proportion of intended monitoring time with valid sensor data
Percentage of the intended monitoring period during which each sensor provided valid StO2 and PPG data, per sensor site, including data recovered from onboard memory after wireless transmission gaps.
Time frame
Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application2
Patient tolerance: device-related adverse events and device deficiencies
Number and percentage of participants with adverse events, adverse device effects (including skin irritation or redness at the adhesive site), and device deficiencies, and number of participants requesting early sensor removal.
Time frame
From enrollment through sensor removal, approximately 24 to 72 hours3
Association between NIRSense measurement trends and change in SCAI shock stage
Change in NIRSense measurements (StO2, StO2 variability, perfusion index, stroke volume) relative to the time of clinically documented change in SCAI shock stage, including the lead time between the first sustained change in device metrics and the clinically recognized deterioration.
Time frame
Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application4
Distribution of NIRSense measurements by SCAI shock stage
Summary statistics of StO2, perfusion index, and ICG-derived stroke volume at each sensor site by SCAI shock stage (B, C, D, E), to inform development of a predictive model of shock status.
Time frame
Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor applicationOther outcomes
1
Clinical staff usability feedback
Responses to a paper survey completed by study staff (principal investigator, nurses, residents, and others involved in the study) on their experience using the sensor system.
Time frame
After the device has been used on 5 patients (approximately 1 to 6 months after first enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NIRSense Inc.
Lead sponsor
Cleveland Clinic Florida
Collaborator
Source ClinicalTrials.gov