Active clinical trials for "Respiratory Distress Syndrome"

In patients with severe acute respiratory distress syndrome, extracorporeal membrane oxygenation (ECMO), which also as known as extracorporeal life support, may be used. This technique helps the lungs by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO device includes a pump for draining and returning blood at a certain blood flow rate (ECMO blood flow). An ECMO rate that is adapted to the patient's cardiac output (CO) is essential for effective oxygenation for patients. The objective for clinicians is an ECMO blood flow to cardiac output ≥40%, which can go up to 100% as needed. In addition to the expected benefit in the management of the patient with ARDS, measuring CO is, therefore, all the more important in patients requiring ECMO. Monitoring CO in a patient with ECMO is not only for determining the minimum ECMO blood flow rate but also for optimizing the functioning of the ECMO. However, the validity of techniques for measuring CO in patients with ECMO has been poorly studied. The reliability of the CO measurement by transpulmonary thermodilution is questioned since the extracorporeal circulation may influence the pathway of cold indicator injected into the patients' circulation and the thermodilution curve measured from the femoral arterial is thereby modified.

Acute Respiratory Distress Syndrome (ARDS) is associated with a mortality rate of 30 - 45 % and required invasive mechanical ventilation (MV) in almost 85 % of patients[1]. During controlled MV, driving pressure (i.e., the difference between end-inspiratory and end-expiratory airway pressure) depends of both tidal volume and respiratory system compliance. Either excessive tidal volume or reduced lung aeration may increase the driving pressure. ARDS patients receiving tidal volume of 6 ml/kg predicted body weight (PBW) and having a day-1 driving pressure ≥ 14 cmH2O have an increased risk of death in the hospital[2]. Seemly, in the LUNG SAFE observational cohort, ARDS patients having a day-1 driving pressure < 11 cmH2O had the lowest risk of death in the hospital[1]. Hence, driving pressure acts as a major contributor of mortality in ARDS, and probably reflects excessive regional lung distension resulting in pro-inflammatory and fibrotic biological processes. Whether decreasing the driving pressure by an intervention change mortality remains an hypothesis; but one of means is to decrease the tidal volume from 6 to 4 ml/ kg predicted body weight (PBW). However, this strategy promotes hypercarbia, at constant respiratory rate, by decreasing the alveolar ventilation. In this setting, implementing an extracorporeal CO2 removal (ECCO2R) therapy prevents from hypercarbia. A number of low-flow ECCO2R devices are now available and some of those use renal replacement therapy (RRT) platform. The investigators previously reported that combining a membrane oxygenator (0.65 m²) within a hemofiltration circuit provides efficacious low flow ECCO2R and blood purification in patients presenting with both ARDS and Acute Kidney injury[3]. This study aims to investigate the efficacy of an original ECCO2R system combining a 0.67 m² membrane oxygenator (Lilliput 2, SORIN) inserted within a specific circuit (HP-X, BAXTER) and mounted on a RRT monitor (PrismafleX, BAXTER). Such a therapy only aims to provide decarboxylation but not blood purification and has the huge advantage to be potentially implemented in most ICUs without requiring a specific ECCO2R device. The study will consist in three periods: The first period will address the efficacy of this original ECCO2R system at tidal volume of 6 and 4 ml/kg PBW using an off-on-off design. The second part will investigate the effect of varying the sweep gas flow (0-2-4-6-8-10 l/min) and the mixture of the sweep gas (Air/O2) on the CO2 removal rate. The third part will compare three ventilatory strategies applied in a crossover design: Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA). Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table (ARMA).

The aim is to test a device for applying continuous negative abdominal pressure in patients with ARDS

Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation

Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor. Positioning in the prone position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS. However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers. There are other positioning techniques such as the "upright" position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS. However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details. Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table. The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.

Ventilator-induced diaphragmatic dysfunction and intensive care unit (ICU)-acquired weakness are two consequences of prolonged mechanical ventilation and critical illness in patients with acute respiratory distress syndrome (ARDS). Both complicate the process of withdrawing mechanical ventilation, increase hospital mortality and cause chronic disability in survivors. During transition from controlled to spontaneous breathing, these complications of critical illness favor an abnormal respiratory pattern and recruit accessory respiratory muscles which may promote additional lung and muscle injury. The type of ventilatory support and positioning may affect the muscle dysfunction and patient-self-inflicted lung injury at spontaneous breathing onset. In that regard, ARDS patients with ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness who are transitioning from controlled to partial ventilatory support probably present an abnormal respiratory pattern which exacerbates lung and muscle injury. Physiological-oriented ventilatory approaches based on prone positioning or semi recumbent positioning with abdominal binding at spontaneous breathing onset, could decrease lung and muscle injury by favoring a better neuromuscular efficiency, and preventing intense inspiratory efforts and high transpulmonary driving pressures, as well as high-magnitude pendelluft. In the current project, in addition to perform a multimodal description of the severity of ventilator-induced diaphragmatic dysfunction and ICU-acquired weakness in prolonged mechanically ventilated ARDS patients, prone positioning and supine plus abdominal binding at spontaneous breathing onset will be evaluated.

Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.

Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. Scientific evidence has considered neuromuscular electrical stimulation (NMES) as a promising approach for the early rehabilitation of patients during and/or after ICU. Neuromuscular electrostimulation can be an alternative form of muscle exercise that helps to gain strength in critically ill patients with COVID -19, due to the severe weakness that patients experience due to longer MV, analgesia and NMB duration. Thus, the general objective of evaluating the effects of an early rehabilitation protocol on the strength and functionality of patients affected by SARS-CoV-2 variants and specifically compare the effectiveness of NMES associated with the functional rehabilitation protocol(FR). Also, describe demographics, clinical status, ICU therapies, mortality estimates and Hospital outcomes, of every patients admitted in ICU during the observation periods.

This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.

This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).