27 Clinical Trials for Various Conditions
The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart. In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings. Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs. For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded. For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery. A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed. Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.
Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements. Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.
This study is a prospective observational chart review. The aim of the study is to evaluate tricuspid regurgitation volume using 3D volumetric assessment as an accurate method for tricuspid regurgitation severity in comparison to VCA.
The purpose of this study is to better understand if transesophageal echocardiography during cardiac surgery can predict problems with kidney function after cardiac surgery.
Image quality of intraoperative transesophageal echocardiography (TEE) tends to get worse during long hours of operations. An orogastric tube (OGT) is often inserted in the beginning of the case, and left there for intermittent suction as needed, or removed before TEE exam to prevent echoic artifacts. However, if left there, the effect of suction might be limited due to unreliable tip position of the OG tube. If removed, stomach will be distended again. We devised the OG tube attached TEE for practical suction and assessed its effect on image quality intraoperatively.
The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used to successfully guide an epidural catheter to a targeted thoracic level in pediatric patients. The catheter will be placed in the epidural space under real-time TEE imaging and assistance by a trained TEE operator (this could include an anesthesiologist or cardiologist).
The aim of this prospective observational study is to assess whether transesophageal echocardiography (TEE) can be used to identify the structures within the vertebral foramen of the spinal column and to determine the range of spinal segments which can be visualized.
The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical gold standard imaging modality for visualization of the right atrial appendage (RAA) and left atrial appendage (LAA) for detection of thrombi as well as risk factors associated with thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative imaging modalities that can visualize these structures. Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture and periprocedural catheter visualization. A majority of imaging acquired during AF ablation is performed with the ICE catheter in the right atrium (RA). However, these standard views are often unable to provide sufficient visualization of the LAA structure due to the relatively long distance between the ICE catheter and LAA. Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of the LAA over other locations by reducing the anatomic distance between the imaging catheter and structure of interest. Recent retrospective studies have confirmed improved assessment of the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared with TEE for evaluation of LAA thrombus. However, these studies did not systematically evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA. Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is required. We hypothesize that this prospective and blinded study will confirm ICE as non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of thrombi.
Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery. The purpose of the study is to compare these two methods of echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely performed simultaneously. The study will also compare the echocardiography data to a third technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.
The investigators hypothesize that transesophageal echocardiography is a valid method to obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a correlation between abnormal TEE resistive index measurements, intraoperative events and post-operative creatinine changes
The study doctors are trying to determine if the TEE measurements from your stomach are helpful in measuring the blood flow to the kidneys.
SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm. HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Each patient will receive three randomized bubble studies (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent. The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10 mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video (\~200 studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection will be monitored and recorded.
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure. Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.
The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation. Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve replacement (AVR): surgical AVR (SAVR), mini-sternotomy AVR (mini AVR), and transcatheter AVR (TAVR).
The purpose of the study is to collect user feedback on the Vivid E95 ultrasound system and probes during clinical procedures on the device's intended population in order to optimize the device.
The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.
The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia. These dental protector devices are class I devices which are exempt from the FDA 510(k) premarket notification requirements.
This is a pilot study of patients undergoing structural heart disease procedures that utilize TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical Center. Patients in this study will undergo their procedure utilizing the TEE/Angio fusion software prototype. This protocol is primarily intended to ascertain the potential utility of the software prototype in the study population and to provide data and feedback to improve the workflow and algorithms of the prototype. As such, a primary outcome variable and statistical analysis plan have not been identified. However, procedural time, measures of radiation exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual valvular regurgitation or paravalvular regurgitation as applicable, and complications will be recorded.
The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation. Despite these improved outcomes, procedure related length of hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One important reason for this is that many people experience right ventricular dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent studies suggest that correction of the TV during LVAD implantation has improved survival for those with severe regurgitation. However, this has not been evaluated for mild or moderate regurgitation. The goal of this study is to look at the clinical impact of surgical correction of mild to moderate TR in participants who are also undergoing LVAD implantation. The study will look at the degree of TR at various time points post-surgery, as well as any major cardiac adverse events, duration of hospitalization, and quality of life. The investigators hope to show that surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular dysfunction and have a positive impact on health outcomes.
The study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography.
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal echocardiography (TEE). RLS intracardiac shunts are associated with a number of clinically important syndromes including paradoxical thromboembolism (causing stroke or other systemic infarct), migraine headaches (particularly with aura), desaturation with obstructive sleep apnea, and decompression illness. From a research perspective, the detection of shunts in subjects with these types of syndromes is critical in helping to define the role of RLS in these disease processes. From a clinical perspective, shunt detection will be increasingly important in an era where interventional procedures for repairing cardiac defects are available for subjects determined to be at risk. The currently accepted reference standard for detection of an intra-cardiac patent foramen ovale/atrial septal defect (PFO/ASD) RLS is a transesophageal echocardiography (TEE), a procedure that is invasive, uncomfortable, and requires conscious sedation. Alternative options include transthoracic echocardiography (TTE) with injection of agitated saline (with and without Valsalva strain), a procedure that is far less sensitive than TEE due to the echocardiography imaging limitations seen in many adults. Finally, transcranial Doppler (TCD) with injection of agitated saline (with and without Valsalva strain) is a newer entrant into this arena that does not require sedation or any invasive instrumentation. The Cardiox Model 100 FDS utilizes an optical sensor positioned on the surface of the subject's skin at the scaphoid fossa of the ear. Next, a predetermined dose of an indicator dye, indocyanine green (ICG), is injected at a predetermined rate into a peripheral antecubital vein of the subject while the subject performs a breathing maneuver called a Valsalva maneuver. The exhalation by the subject into a mouthpiece connected to a pressure transducer via a flexible tubing extension, or its equivalent (ie, performing the Valsalva maneuver), is an essential step for all existing RLS detection methods. The Valsalva maneuver by the subject creates a pressure differential between the right and left sides of the heart. This Valsalva maneuver results in blood flow from the right side of the heart to the left side of the heart through an ASD, and/or causes a PFO, if present, to open, also allowing blood to flow directly from the right side to the left side of the heart without passing through the lungs (pulmonary vasculature) for oxygenation. The Earpads, including their fluorescence sensor arrays (FSA), are used to measure the relative concentration (ie, fluorescence signal level) of ICG dye in the bloodstream as a function of time. If a premature inflection or peak occurs in the ICG dye concentration level at a time point prior to the rise and fall of the concentration associated with the main bolus of indicator, then a RLS is present in the heart. The amplitude of this premature ICG dye-dilution curve (referred to as "RLS-indicator dilution curve") is used to subsequently quantify the magnitude of the right-to-left shunt by ratiometrically comparing the amplitude of this RLS indicator dilution curve to the amplitude of the main indicator dilution curve associated with that portion of the injected ICG dye that follows the normal pathway from the right side of the heart, through the lungs, and into the left side of the heart (referred to as "normal indicator dilution curve").
The purpose of this study is to determine whether Libman-Sacks endocarditis (inflammation of the heart valves) is the cause of neuropsychiatric manifestations (stroke, transient ischemic attacks, cognitive dysfunction, seizures, acute confusional state, or psychosis) in patients with systemic lupus erythematosus. Hypothesis of the study: Libman-Sacks endocarditis (especially valve vegetations or "small valve growths") generate macro (large) and micro (tiny) emboli that occlude the medium and small cerebral vessels resulting in altered perfusion, ischemic brain injury, and major NPSLE (stroke, TIA, seizures, cognitive dysfunction, acute confusional state, or psychosis).
The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
In this study researchers plan to perform a diagnostic test called transesophageal echocardiography in order to see and record the movement and function of the heart. Transesophageal echocardiography is similar to an upper gastrointestinal endoscopy. Different views of the heart are taken by a small, flexible instrument positioned in the esophagus (the tube that connects the mouth to the stomach). This allows doctors to create a clear picture of the heart through the wall of the esophagus rather than from outside the body through the muscles, fat, and bones of the chest wall. During transesophageal echocardiography pictures of the heart will be taken while patients rest and as patients receive a medication called dobutamine. Dobutamine is a medication that makes the heart beat stronger and faster, similar to what exercise does to the heart. Researchers are particularly interested in studying patients with defects in the valves of the heart, especially aortic regurgitation and mitral regurgitation. Patients with these defects in the heart valves tend to develop abnormalities in the size and function of the left ventricle. The left ventricle is one of the four chambers of the heart responsible for ejecting blood out of the heart into the circulation. Researchers believe that by identifying changes in the function of heart muscle, they may be able to predict the occurrence of muscle damage due to the diseased valves. The purpose of this study is to determine whether the function of heart muscle measured during dobutamine stress transesophageal echocardiography can predict the later development of problems in the function and size of the left ventricle.