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

Clinical Evaluation of Using NIRSense Sensor Patch to Measure Microvascular Perfusion Responses and Predict Decompensation in Cardiogenic Shock Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Heart tracing (ECG), Pills, Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Clinical staff complete a usability survey after using the device on 5 patients."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether wearable sensors can spot worsening heart-related shock earlier, when the heart cannot pump enough blood. It is for adults in the Cleveland Clinic Florida heart intensive care unit with a heart attack or worsening heart failure. Patients wear the sensors for about 24 to 72 hours during usual care, and sensor readings do not guide treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have worsening heart failure with symptoms needing treatment and heart failure listed as a reason for the hospital stay; OR have a heart attack and undergo a test that uses dye and X-rays to check heart arteries.
  • Be in the intensive care unit with heart-related shock at stage B, C, or D on the SCAI scale used by doctors.
  • Be age 18 or older.
  • Weigh more than 40 kg (about 88 pounds).

Who can't join

  • Have a known severe allergy to medical tape or the glue used to attach medical products.
  • Be in another study of an experimental drug or device that could affect this study. Long-term follow-up for a product now sold commercially does not count as an experimental study.
  • The study doctor believes you are not a suitable person for this study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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-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

Study sites (1)

FL