View clinical trials related to Pulmonary Congestion.
Filter by:This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion. Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent. 1. Liberal oxygenation group = SpO2 target of 96%. 2. Restrictive oxygenation group = SpO2 target of 90%. The allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC. The study will include 122 patients.
1. Introduction and aims: Transcatheter aortic valve replacement (TAVR) is the gold standard for the treatment of elderly patients with severe aortic valve stenosis (AS). AS causes left ventricular remodeling as well as left atrial enlargement, pulmonary artery and right ventricular changes, these changes, and whether they are reversible (reverse remodeling) are major determinants of outcome after TAVR. Heart Failure (HF) is the most frequent cause of cardiac re-hospitalization after TAVR. Most HF exacerbations are related to a progressive rise in cardiac filling pressures that precipitates pulmonary congestion and symptomatic decompensation. Traditionally, pulmonary congestion has been assessed by physical examination and chest radiography but clinical signs and symptoms of congestion are poor surrogates for ventricular filling pressures and are not reliable predictors of imminent hospitalization. Recently, lung ultrasonography (LUS) has been identified as a sensitive and semi-quantitative tool for the assessment of pulmonary congestion in HF. The technique is based on the detection of vertical echogenic artifacts arising from the pleural line, named "B-lines". The number of B-lines is associated with increased risk of adverse events during hospitalization and after hospital discharge. CLUSTER-HF Trial demonstrated that the routine incorporation of LUS during clinical follow-up of patients with recent acute decompensated HF without a surgically correctable cause, was associated with a risk reduction of adverse HF events, mainly urgent HF visits. Thus, LUS could represent a promising tool to detect pulmonary congestion related to AS. To date, there are no studies on the role of LUS in the context of AS and TAVR. The study hypothesis is that in patients with higher number of B-lines before-TAVR and after TAVR, the rate of adverse events during follow-up is higher. 2. Study design: This is a single center prospective study carried out at Fondazione Policlinico Gemelli IRCCS, Roma and involving patients with severe aortic stenosis submitted to TAVR treatment. The expected recruitment period is approximately one year For patients fulfilling inclusion/exclusion criteria, all data about clinical status leading to TAVR, exams and any specific documentation during hospitalization will be collected. 3. Number of patients: For the primary end-point, a sample-size of 91 is computed using the one-sample chi-square test and assuming a proportion of LUS-evaluated pulmonary congested patients before TAVR of 50% and a proportion of 35% of LUS-evaluated pulmonary congested patients after TAVR. To accommodate for possible missing investigations, sample size will be increased to 105 patients. The secondary end-point is the association between pre-TAVR and post-TAVR B-lines and long-term outcomes. Based on previous studies, the investigators know that the incidence of rehospitalization for heart failure during one-year after TAVR is 14% and that patients suffering from heart failure without LUS-evaluated pulmonary congestion are at very low risk of heart failure rehospitalization during follow-up. So, for sample size calculation of the secondary endpoint, the investigators estimated a cumulative incidence higher in the LUS- evaluated pulmonary congestion group with more than 16 B-lines on all scanning sites (30% of events during 1-year of follow-up) with a lower incidence of 8% in the remaining patients. With an HR of 5 favoring patients wit less than 15 B-Lines on all scanning, and aiming to a 2-sided alpha level of 0.05 and a power of 80% the investigators estimated 144 patients. To accommodate for possible missing investigations, sample size will be increased to 150 patients. 4. In-hospital study schedule: For each patient, the investigators will obtain from our general hospital database the following clinical data: - Demographic and clinical data documentation; - Clinical examination: before TAVR, before discharge and when adverse events occur; - Blood analysis; - TAVR procedural characteristics and complications. 5. Instrumental diagnostic exams (Echocardiography and lung ultrasound): Each patient will be evaluated before and after TAVR with a comprehensive echocardiogram and LUS for the evaluation of the pulmonary congestion. All the evaluations will be performed the day before TAVR and after TAVR. In consideration of the operator's dependence on ultrasound methods to reduce the error rate, all examinations will be performed by qualified personnel. 6. Clinical follow up assessment: Clinical follow up information will be obtained from: visits, review of the patient's hospital record, personal communication with the patient's physician and review of the patient's chart, a telephone interview with the patient conducted by trained medical personnel The following information will be recorded: clinical status assessment, adverse event assessment, record cardiac medications.
Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.
There is a concept increasingly consolidated by clinical evidence that at each hospitalization due to HF decompensation there is a substantial loss of quality of life, which is associated with an initial period of great clinical vulnerability, with high rates of rehospitalization and an increased risk of death. The non-pharmacological measures that are widely practiced and recommended for HF patients, such as fluid restriction, specially at the first 30 days after hospital discharge, still lack clearer evidence of their therapeutic efficacy.
Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS) and sepsis. The clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies. Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as well as the bedside gold standard, transpulmonary thermodilution in adults. Critically ill children are more susceptible to complications and worsened outcomes from increased EVLW. Lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution. Evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development. It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.
Heart failure (HF) is a major health problem, which is characterized by reduced cardiac function leading to pulmonary congestion. Most episodes of acute HF requiring unplanned hospitalization are due to pulmonary congestion. There is an urgent clinical need for quantitative, reproducible, minimally invasive, and noninvasive methods to assess thoracic fluid status. The potential value of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to this end has been suggested and demonstrated in-vitro. In this study the investigators aim to compare intra-thoracic fluid volume assessed by DCE- MRI using bolus kinetic parameters of the indicator dilution theory and bioimpedance spectroscopy (BIS). Primary objectives: This study evaluates the correlation between change in BIS and change in bolus kinetic parameters in response to a fluid challenge. Secondary objectives: The sensitivity of the bolus kinetic parameters to fluid challenges and the normal range DCE-MRI bolus kinetic parameters is evaluated in healthy subjects. Study design: Prospective nonrandomized pilot study. Study population: Healthy volunteers. Intervention: The subjects will receive an intra-venous injection of gadolinium, a MRI contrast agent. External pressure will be applied by means of a leg-compression device in order to induce a rapid increase of the preload by blood auto-transfusion. Main study parameters: Pulmonary transit time (PTT), skewness of the indicator dilution curve which is a measure of trans-pulmonary dilution, intrathoracic blood volume (ITBV), changes in bolus kinetic parameters, and thoracic impedance in response to fluid challenges. The correlation between changes in bolus kinetic parameters and thoracic impedance in response to fluid challenges.
The purpose of this study is to determine if IMED-4 recordings have sufficient precision to detect a clinically significant change in lung fluid status in acute heart failure syndrome with pulmonary congestion.
The purpose of this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath.