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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Thibault Roumengous, PhD
- Phone Number: 804-625-1135
- Email: thibault@nirsense.com
Study Locations
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Florida
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Weston, Florida, United States, 33331
- Recruiting
- Cleveland Clinic Florida, Weston Hospital
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Contact:
- David A. Baran, MD
- Phone Number: 954-659-5290
- Email: barand@ccf.org
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Contact:
- Maxwell Sapper
- Email: sapperm2@ccf.org
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Principal Investigator:
- David A. Baran, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acute myocardial infarction
Patients with acute myocardial infarction, with or without shock (SCAI stage B to D), admitted for coronary angiography and subsequent interventions.
Enrolled at the time of consent for coronary angiography.
|
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.
Other Names:
|
|
Acute decompensated heart failure
Patients with acute decompensated heart failure (SCAI stage B to D) admitted for pulmonary artery catheter insertion and subsequent interventions.
Consented before or after catheterization.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between NIRSense sensor measurements and standard-of-care hemodynamic parameters
Time Frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
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).
|
Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: proportion of intended monitoring time with valid sensor data
Time Frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
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.
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Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
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Patient tolerance: device-related adverse events and device deficiencies
Time Frame: From enrollment through sensor removal, approximately 24 to 72 hours
|
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.
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From enrollment through sensor removal, approximately 24 to 72 hours
|
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Association between NIRSense measurement trends and change in SCAI shock stage
Time Frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
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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.
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Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
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Distribution of NIRSense measurements by SCAI shock stage
Time Frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
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.
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Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical staff usability feedback
Time Frame: After the device has been used on 5 patients (approximately 1 to 6 months after first enrollment)
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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.
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After the device has been used on 5 patients (approximately 1 to 6 months after first enrollment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David A. Baran, MD, Cleveland Clinic Florida
- Study Director: Thibault Roumengous, PhD, NIRSense Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSE2401
- 25-127 (Other Identifier: Cleveland Clinic IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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