View clinical trials related to Respiratory Distress Syndrome.
Filter by:The main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ARDS due to SARS-CoV-2.
Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.
ARDS is characterized by a diffuse, bilateral, extensive alveolar-interstitial infiltrate related to damage to the alveolar membrane. Studies of lung morphology assessed by CT scan have shown 2 types of ARDS. When the loss of ventilation is posterior and caudal, and the pulmonary parenchyma is otherwise "healthy", ARDS is said to be focal. When the loss of ventilation is diffuse, associated with excess tissue affecting the entire lung parenchyma, ARDS is said to be non-focal or diffuse. Only one recent multicenter study has evaluated whether individualized PEEP adjustment according to lung morphology (focal vs. non-focal) could improve ARDS survival outcomes compared with standard of care. Results for the primary endpoint, 90-day mortality, were negative. But lung morphology was misclassified on CT occurred 85 (21%) of 400 patients. In addition, per-protocol analysis in which misclassified patients were excluded showed that mortality was significantly lower in the personalized ventilation group than in the control group. Lung ultrasound may be the ideal bedside imaging technique. The loss of pulmonary aeration and its variations induced by therapeutic maneuvers can be quantified by lung ultrasound. Lung ultrasound is a non-invasive, non-ionizing radiation method that can be easily used at the bedside. APRV ventilation coupled with spontaneous breathing activity prevents atelectasis formation, recruits less ventilated areas, prevents mechanical ventilation-induced lung injury and improves lung compliance. The hypothesis is that a "LUVS" ventilatory strategy composed of a bundle of measures all aiming at reopening the atelectatic pulmonary zones in focal ARDS (synergistic effect of spontaneous ventilation in APRV mode, early prone sessions, and adjustment of PEEP according to the patient's BMI), could decrease the number of days under mechanical ventilation, compared to protective ventilation with low tidal volume according to the current international recommendations
COVID-19, a novel coronavirus, has caused widespread mortality and morbidity since it emerged in 2019. There is ongoing research and growing literature describing severe acute respiratory syndrome (SARS-COV-2). There is a growing population of individuals who have recovered from acute SARS-COV-2 infection. The long-term effects of COVID-19 are unknown. There are growing reports of sequelae after acute SARS-CoV-2 not limited to fatigue, dyspnea, reactive airway disease, organizing pneumonia, pulmonary fibrosis, pulmonary hypertension, pulmonary emboli, and tracheal disease. The incidence and natural history of these findings is unstudied.
Modern management of acute respiratory failure aims to relieve dyspnea and anxiety by providing a non-invasive respiratory support. This approach tries to avoid endotracheal intubation, patient self inflicted lung injuries (PSILI) and diaphragmatic dysfunction. The present study aims to evaluate dyspnea, pulmonary regional ventilation and diaphragmatic function in patients with hypoxemic acute respiratory failure by different observations, and to bring risk factor for intubation out.
Introduction: Inadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients. Methods and analysis: BECAME is a single center, open label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participant per arm will be also teste for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ~350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial. Ethics and dissemination: The trial is approved by local ethics committee of Rabin medical center (RMC-0192- 21). Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee.
The COVID-19 pandemic has led to an increase in the number of patients admitted to intensive care units (ICU) with acute respiratory distress syndrome (ARDS). ARDS is a severe, life-threatening medical condition characterised by inflammation and fluid in the lungs. There is no proven therapy to reduce fluid leak, also known as pulmonary oedema, in ARDS. However, recent studies have discovered that imatinib prevents fluid leak in the lungs in inflammatory conditions, while leaving the immune response intact. Adding imatinib into the standard care package may, therefore, decrease mortality and reduce the duration of mechanical ventilation compared with standard care alone, in critically-ill patients with COVID-19. To help determine the impact of imatinib in these patients we present a randomised, double-blind, multi-centre, 2-arm, parallel-group, placebo-controlled clinical study of intravenous imatinib in 84 mechanically-ventilated, adult subjects with COVID-19-related ARDS. Study participants (patients who have consented into the study) will receive the study drug (imatinib or placebo) twice daily for a period of 10 days. The effect of the intervention will be tested by measuring the change from baseline in the Oxygen Saturation Index (OSI) at day 10. OSI is a non-invasive means of measuring oxygenation and is an independent predictor of mortality in patients with ARDS, serving thus as a relevant endpoint from which to assess the efficacy of imatinib. Other measurements will include regular blood tests as part of safety assessments. Time on ventilation and morbidity and mortality will be recorded as secondary outcome measures. Blood tests will also allow the investigation of the pharmacokinetic properties of imatinib, as well as biomarkers of inflammation.
Surveys administered to subjects who have recovered from COVID-19 to assess how effective their treatment was.
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.
This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and child mass screening.