21 Clinical Trials for Various Conditions
Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac surgery. It allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. The imaging of cardiac structures is used to direct optimal surgical intervention and assess surgical results. Cardiac output (CO) is the result of stroke volume (SV) multiplied by the heart rate. Measurement of cardiac output (CO) is used to quantify the performance of the left ventricle. It is commonly achieved using a pulmonary artery catheter (PAC) (also known ad Swann-Ganz catheter). A known amount of saline solution is injected in the proximal part of the catheter and the variation of blood temperature detected at the tip. Cardiac output is measured based on the duration and degree of temperature change. This method remains an accepted gold standard. TEE allows measurement of cardiac output using a number of different 2D and 3D imaging modalities. Although current guidelines identify the Method of the Disks(MOD) as the gold standard other technique could potentially be more precise. In this study, the investigators want to assess the accuracy of four different TEE methods to measure cardiac output compared with Thermodilution as a standard of care.
The purpose of the study is to learn more about how the heart works during cesarean delivery under spinal anesthesia (medicines given in the spine that numb parts of your body to block pain) in women. The investigators would like to find out if the information about the heart can help in treating blood pressure changes that occur during the cesarean delivery. The investigators would also like to find out if this information can help reduce the chances of nausea and vomiting during the cesarean delivery. The activity of the heart changes during spinal anesthesia and cesarean section. In the past, a sensor placed directly into the heart was the only way to see how the heart worked. Currently, there are monitors that can sense the heart's activity via sensors that are placed on the skin during cesarean delivery. In this study, the investigators will use the ICON cardiac output (ICON) monitor. The ICON monitor is approved by the US Food and Drug Administration (FDA) to monitor (check) the activity of your heart. This study aims to: 1. Determine if additional cardiac output measurements help anesthesiologists maintain appropriate hemodynamics as defined as within 20% of baseline BP and if it changed their choice of vasopressors (primary outcome). 2. Determine if additional cardiac output measurements help to decrease the incidence of nausea and vomiting during cesarean delivery (secondary outcome).
The investigators would like to find out if AESCULON®, a new device that non-invasively and continuously measures cardiac output using electrical cardiometry, works as well as one existing method--Fick method in patients undergoing cardiopulmonary exercise testing.
The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (\<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent cardiac output will be obtained and compared on participants using standard 2-D TTE and Ultrasound Cardiac Output Monitor (USCOM).
Subjects in this study have been diagnosed with pulmonary hypertension and their doctors have referred them for an exercise test as part of their normal, routine care. The exercise test will either be a treadmill test or a 6 minute walk test. During a treadmill test, a patient typically walks on a treadmill while their heart is monitored using an electrocardiogram, which records the electrical activity of the heart through 10 small electrode patches attached to the skin of the chest, arms and legs. Additionally, heart rate and blood pressure are monitored throughout the test. A 6-Minute Walk test requires patients to walk for up to 6 minutes to determine how far they can go in order to measure the heart function related to exercise. The purpose of this study is to measure internal heart pressures using a device called Noninvasive Cardiac Output Monitoring (NICOM) during an exercise test. Normally heart pressures are measured during invasive (meaning that doctors have to go inside the body using a needle or surgery) heart procedures. The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. In this study, the investigators will evaluate the non-invasive measurements provided by the NICOM device during the exercise test and see how it relates to information from some of subjects' past heart procedures. This research is being done to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the exercise test that is scheduled as part of the subjects' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in pediatric patients undergoing surgery involving cardiopulmonary bypass (CPB). Cardiac output will be measured after cardiopulmonary bypass using a device that employs ultrasound dilution technology. At times, cardiac output will be measured during a procedure called modified ultrafiltration (MUF). The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using other FDA approved techniques and devices.
This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using AI-based software (CardioMIND and CardioQSync). The study devices offer non-invasive, multiplexed, AI-enabled direct-from-ECG detection as a novel alternative to traditional diagnostic methods, including imaging, hemodynamic monitoring systems, catheter-based devices, and biochemical assays. Continuous COR ECG data collected in hospital, outpatient clinic, or home settings will be analyzed to evaluate the predictive accuracy, sensitivity, specificity, and performance of these devices in differentiating between screen-positive and screen-negative subjects. The panel of screened indications encompasses a broad spectrum of clinically relevant cardiovascular, cardiopulmonary, and sleep-related diagnostic parameters, which are critical for advanced patient assessment and management. In the cardiovascular domain, the protocol emphasizes the detection and classification of heart failure, assessment of ejection fraction severity, and identification of myocardial infarction, including pathological Q-waves and STEMI. It further addresses diagnostic markers for arrhythmogenic conditions such as QT interval prolongation, T-wave alternans, and ventricular tachycardia, as well as insights into ischemia, atrial enlargement, ventricular activation time, and heart rate turbulence. Additional parameters, such as heart rate variability, pacing efficacy, electrolyte imbalances, and structural abnormalities, including left ventricular hypertrophy, contribute to comprehensive cardiovascular risk stratification. In the non-invasive cardiopulmonary context, the protocol incorporates metrics like respiratory sinus arrhythmia, cardiac output, stroke volume, and stroke volume variability, providing critical insights into hemodynamic and autonomic function. The inclusion of direct-from-ECG metrics for sleep-related disorders, such as the apnea-hypopnea index, respiratory disturbance index, and oxygen saturation variability, underscores the protocol's utility in addressing the intersection of cardiopulmonary and sleep medicine. This multifaceted approach establishes a robust framework for precision diagnostics and holistic patient management. The COR 1.0 and COR 2.0 wearables provide multi-lead ECG recordings, with COR 2.0 offering extended capabilities for cardiopulmonary metrics and longer battery life (up to 14 days). COR 2.0 supports tri-modal operations: (i) Extended Holter Mode: Outputs Leads II and III, mirroring the functionality of COR 1.0 for broader ECG monitoring applications. (ii) Cardiopulmonary Mode: Adds real-time recording of Lead I, V2, respiratory impedance, and triaxial accelerometer outputs, providing advanced cardiopulmonary insights. (iii) Real-Time Streaming Mode: Streams data directly to mobile devices or computers via Bluetooth Low Energy (BLE), enabling real-time waveform rendering and analysis. The COR 2.0 units are experimental and not yet FDA-cleared. Primary endpoints include sensitivity (true positive rate) \> 80%, specificity (true negative rate) \> 90%, and statistical agreement with reference devices for cardiovascular, cardiopulmonary, and sleep metrics. Secondary endpoints focus on predictive values (PPV and NPV) and overall diagnostic performance. The study employs eight distinct sub-protocols (A through H) to address a variety of cardiovascular, cardiopulmonary, and sleep-related diagnostic goals. These sub-protocols are tailored to specific clinical endpoints, varying in duration (30 minutes to 14 days) and type of data collection. Up to 15,000 participants will be enrolled across multiple sub-protocols. Screening ensures eligibility, and subjects must provide informed consent before participation. Dropouts and non-compliant subjects will be excluded from final analyses.
The purpose of this study is to test the accuracy of a new noninvasive way to measure how much blood our heart pumps per minute. This new way measures the heart's pumping activity from outside the body, instead of breaking the skin and measuring it from the inside. Subjects will breathe normally through a mask while we record how fast and how much air they are breathing. We will have them "re-breathe" some of the air they breathed out by adjusting the ventilator. During this time, we will use the air breathed out to calculate how much blood per minute the subject's heart is pumping. We will also measure how much blood the heart is pumping at this time by injecting fluid into the catheter in the neck and then drawing about 1 teaspoon of blood from the catheters in the neck and arm. We will compare the calculated and measured values of the amount of blood pumped out of the heart for accuracy. After we complete this procedure, we will remove the mask and allow you to rest for 10-30min. Following the rest period, we will repeat the process and collect a second set of measurements. We will draw a total of 4 teaspoons of blood for the study. If you cannot comfortably breathe along with the ventilator, we will withdraw you from the study. If you want to stop taking part in the study at any time, let the study doctor know that you wish to withdraw. We will take off the mask, and your time in the study will end. This decision will not affect your regular medical care.
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are severe clinical conditions that, despite advances in therapeutics over the past 20 years, lead to serious morbidity and mortality. Guidelines on the diagnosis and treatment of pulmonary hypertension (PH) recommend the use of a multiparametric risk stratification tool to determine severity of disease, which should guide initial therapy and therapy modulation. This multiparametric risk stratification schema includes objective assessment of exercise capacity, right ventricular function and hemodynamic parameters in order to classify patients into severity categories. Cardiac index (CI) and right atrial pressure (RAP), measured via right heart catheterization (RHC), are the hemodynamic parameters used in risk assessment of PH. Arguably, stroke volume index (SVI) is the most important hemodynamic parameter for assessment of PH severity and there is currently no validated method for noninvasive measurement of cardiac output (CO), CI or SVI. Currently, a major obstacle in the field is that hemodynamic measurements are not obtained on a regular basis in the risk assessment and therapy modulation of patients with PAH and CTEPH. If a noninvasive method of hemodynamic measurement could be correlated with other objective measurements of risk assessment, it could become an invaluable tool in therapy initiation and modulation in the ambulatory setting. This is a single center study to evaluate the use of non-invasive measurement of CO and stroke volume to assess risk and response to treatment in patients with PAH and non- operable CTEPH. We anticipate to enroll a total of 100 subjects at Ronald Reagan UCLA Medical Center. A maximum of 10 hour in total for the study including the consent process, pre-procedure care, RHC procedure, and follow up visit. The initial visit will be approximately 4 hours with the RHC procedure itself will only be 20 minutes. Each follow up visit will be 1.5 hour. Patients with known or suspected PAH or CTEPH will undergo a RHC as part of his or her standard of care. Three techniques of CO measurement will be performed sequentially at the time of the RHC. The device that will be used is the Edwards ClearSight system and EV1000 clinical platform, a device that measures NIBP. Patients will be followed over the period of 1 year every 3 months to obtain serial measurements for six-minute walk distance (6MWD), World Health Organization (WHO)/New York Heart Association Functional Class (FC), B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP), and non-invasive hemodynamic measurements. Additional visits will be scheduled to obtain the serial measurements one month prior and one month following if a patient is initiating or changing PH-specific therapy. As this is a study looking at the feasibility of non-invasive measurement of cardiac output and stroke volume for risk assessment and response to therapy in pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH), study personnel performing the study procedures will not be blinded to the clinical diagnosis and the management of the subject.
Pulmonary embolism impacts over 1 in 1000 adults annually and is the third leading cause of cardiovascular death after heart attack and stroke. The consequence of each PE is widely variable. Physiologically, the morbidity and mortality of PE is ultimately caused by failure of the right ventricle. The acute rise in pulmonary vascular resistance caused by a PE can overwhelm the right ventricle, resulting in a drop in cardiac output and death from failure of the heart to provide vital perfusion. Despite the importance of stroke volume and cardiac output in the current understanding of PE mortality, they are notably absent from risk stratification scores because they historically could only be measured invasively. Novel non-invasive methods of estimating stroke volume and associated cardiac output have the potential to revolutionize PE risk stratification and care. Non-invasive blood pressure (NIBP) monitors can even measure stroke volume beat to beat, allowing for continuous evaluation of cardiac function. NIBP systems are typically composed of a finger cuff with an inflatable bladder, pressure sensors, and light sensors. An arterial pulse contour is formed using the volume clamp method of blood pressure measurement combined with calibration and brachial pressure reconstruction algorithms. The stroke volume with each heart beat can be estimated as the area under the systolic portion of the blood pressure curve divided by the afterload. NIBP monitors may improve clinical care of PE because they allow for assessment of dynamic cardiac changes in real time. Detection of worsening stroke volume in acute PE could inform providers of impending cardiac collapse, and improvement of stroke volume may function as a positive prognostic factor or marker of therapeutic success. Use of NIBP monitors during acute PE to identify clinically significant changes in cardiac function may advance both PE prognostication and management. Our clinical study proposes to monitor hemodynamic parameters including stroke volume in patients with acute pulmonary embolism using non-invasive blood pressure monitors. The relationship between hemodynamic parameters and PE outcomes will be assessed, as well as the changes in hemodynamic parameters with PE intervention. To our knowledge, interval monitoring of stroke volume during acute PE with NIBP monitors has never been reported before.
A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" \[LTIA\]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.
Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.
Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."
Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.
Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.
Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system
toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.
This study will test the capability of a non-invasive instrument (the PhysioFlow impedance cardiography instrument) to measure cardiac output in patients with congenital heart disease (CHD). This instrument works by placing electrodes on the skin of a patient and measuring electrical impedance through the chest, which is proportional to blood volume and blood flow at any given time. The instrument has been validated in patients with structurally normal hearts, but in the only two studies using it for patients with CHD, it was deemed too inaccurate for clinical use. The manufacturer of the device would require access to data on the patients in order to improve its accuracy, and that has not been feasible thus far. This study would begin by comparing cardiac output based on the PhysioFlow monitor to standard techniques, then after possible changes to the instrument to enhance accuracy, would test the instrument again in the same way.
The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.
The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.