47 Clinical Trials for Various Conditions
Inhaled nitric oxide in patients with pulmonic valve insufficiency.
We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI.
The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement \[PVR\]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.
Thoracic insufficiency syndrome (TIS) is a complex condition that involves chest wall deformities that can affect normal breathing and lung growth. In most cases, children with TIS are also born with spine disorders such as scoliosis. The inability of the thorax to support normal respiration or lung growth can cause respiratory distress and even mortality. Investigators aim to validate MRI imaging sequences to use as an assessment tool for pulmonary function.
The aim of this study is to see if the Vapotherm High Flow Therapy (HFT) device is effective to provide breathing support to patients with Chronic Obstructive Pulmonary Disease or COPD. The investigators believe that patients using HFT will not require as much use of therapies that provide pressure through a face mask, and are already recognized by FDA as support therapies for respiratory insufficiency.
This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.
Pulmonary Disorders are often categorized as Obstructive or Restrictive disorders. This study will establish two channels of investigation, one group within each type of pulmonary dysfunction. State-of-the-Art Objective analytics will be employed to track patients from baseline and 6 month intervals for up to one year. Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange. COPD is generally considered those who are able to better inspire air than to expel. Restrictive lung dysfunctions are generally considered those who are unable to achieve full inspiration function. Both can create some of the same symptoms, low Oxygen exchange, activity intolerance of exertion, shortness of breath (SOB), Pulmonary Hypertension, Loss of lung structure, Pneumothorax (in emphysema), may mandate supplemental Oxygen therapy, failure of airway mucus management (chronic bronchitis, bronchiectasis, etc), and other failure of lung function issues. Restrictive lung disorders represent a group of pulmonary function losses which are due to acquired fibrosis, congenital fibrotic disorders, functional airway damage (scarring), vascular abnormalities in arterial/venous supply, Air pollution and tobacco smoking, chemical inhalation damage, etc. are felt to be common contributor of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with anti-asthma bronchodilators, steroids, and a variety of combination of topical medications. Study is an interventional study to document the safety and efficacy of use of cSVF in chronic broncho-pulmonary disease within both groups.
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.
This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes. The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes. The objectives of this study are to: * Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation * Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS) * Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals
The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.
Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.
Integrated pulmonary index (IPI) is a tool that monitors respiratory status. It takes into account four parameters: respiratory rate, end-tidal CO2, heart rate and O2 saturation using a pulse oximeter and specialized sidestream CO2 monitor. The device can continuously monitor and display the patient's ventilatory state as a single digit, 1-10. In addition, trends can be kept and it can provide early indication of changes in respiratory status. IPI has only been studied in pediatric patients who are under sedation; however, more uses for the monitoring tool are a possibility. One of those possibilities is to use IPI to monitor pediatric patients during the weaning and extubation process to determine if a specific number, or less than a specific number, is associated with extubation failure. Therefore, clinicians and physicians would be better able to determine if the patient is ready for extubation.
The purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
People with acute respiratory failure usually require the use of an artificial breathing machine, known as a mechanical ventilator. Sedative medications, which help keep people calm and reduce anxiety, are often prescribed for children who are on mechanical ventilators. However, the longer that sedative medications are used, the longer a child may need to remain on mechanical ventilation. This study will evaluate the effectiveness of a team approach to sedation management that aims to reduce the number of days that children with acute respiratory failure require mechanical ventilation.
The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.
The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.