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Respiratory Distress Syndrome clinical trials

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NCT ID: NCT04068038 Active, not recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Pediatric Acute Respiratory Distress Syndrome Asia Study

PARDS Asia
Start date: August 1, 2019
Phase:
Study type: Observational [Patient Registry]

Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high-end expiratory pressure. A recent retrospective study of ventilation practices in Asia showed varying practices with regards to pulmonary and non-pulmonary therapies, including ventilation. This study aims to determine the prevalence and outcomes of PARDS in the Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN). This study will also determine the use of pulmonary (mechanical ventilation, steroids, neuromuscular blockade, surfactant, pulmonary vasodilators, prone positioning) and non-pulmonary (nutrition, sedation, fluid management, transfusion) PARDS therapies. To achieve this aim, a prospective observational study which involves systematic screening of all pediatric intensive care unit (PICU) admissions and collection of pertinent clinical data will be conducted. Recruitment will be consecutive and follow up will continue to intensive care discharge.

NCT ID: NCT04064684 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

Start date: February 4, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).

NCT ID: NCT04044976 Completed - Clinical trials for Respiratory Distress Syndrome

Caffeine Treatment in in the Delivery Room

CAFROOM
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Background. In recent years, particular attention has been paid to all interventions that could help reduce the need for mechanical ventilation MV and, therefore, the risk of BPD. However, early application of non-invasive respiratory supports and early treatment with surfactant fail in 45-50% of cases. Failure frequently depends on the onset of apnea episodes and, therefore, it has been proposed to treat very preterm infants with caffeine already in the delivery room in the first min of life. Hypothesis and objectives of the study. Our aim is to verify the hypothesis that it is possible to administer caffeine in the delivery room intravenously and enterally via an orogastric tube. Study design. Infants 25-29 weeks of gestational age will be enrolled and will be randomized to receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth. The dosage of plasma caffeine concentration will be performed 60+15 min after administration to measure its peak and 60+15 min before the next dose (5 mg/kg/day i.v.). Endpoints. The primary endpoint will be the evaluation of the success rate of intravenous or enteral administration of caffeine in the delivery room. Secondary endpoints will be the evaluation of: number of infants in whom caffeine will be successfully administered by intravenous versus enteral route; number of infants where caffeine will be successfully administered that reached the therapeutic plasmatic range the first dose, confirming the success of the administration; comparison of caffeine blood level obtained with intravenous and enteral administration; frequency of successes in obtaining the therapeutic range after the second dose; frequency of MV within the first 72 hours of life in studied infants. Statistical analysis. In the absence of previous studies to use as a reference and this study being a feasibility study, it was decided arbitrarily to study 20 infants treated in the delivery room with caffeine administered intravenously and 20 infants treated in the delivery room with caffeine administered enterally. The clinical characteristics of the two groups will be described by calculating the mean value and the standard deviation or the rate and percentage. The primary endpoint will be evaluated by calculating the percentage of cases in which caffeine will be successfully administered. The comparison between the number of infants in which caffeine will be successfully administered intravenously versus the enteral route and the comparison between the caffeine plasma level obtained with intravenous and enteral administration will be performed using the Student "t" test for continuous parametric variables, the Wilcoxon rank sum test for non-parametric continuous variables and the χ2 test for categorical variables. A p <0.05 will be considered as statistically significant.

NCT ID: NCT04031794 Recruiting - Clinical trials for Severe Acute Respiratory Distress Syndrome

ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure

Start date: July 22, 2019
Phase:
Study type: Observational [Patient Registry]

Extracorporeal membrane oxygenation (ECMO) had been used to treat refractory hypoxemia associated with acute respiratory distress syndrome (ARDS). There were reported good outcome associated with ECMO for ARDS caused by influenza infection from several ECMO centers. However, the outcome of ECMO support in lower ECMO experience center had not been evaluated. This study aimed to evaluate the outcome of ECMO, comparing with conventional treatment among severe hypoxemic ARDS patients who were admitted in limited ECMO experience hospital.

NCT ID: NCT04023305 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

Sevoflurane PharmacokInetics in ARDS

SPIDERMAN
Start date: February 23, 2020
Phase: N/A
Study type: Interventional

The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung imaging phenotypes (focal vs nonfocal) during ARDS in ICU patients.

NCT ID: NCT04012073 Recruiting - Clinical trials for Respiratory Distress Syndrome, Adult

Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute Respiratory Distress Syndrome

IPERPEEP
Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

During the acute respiratory distress syndrome (ARDS), patients' response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a tool to individualize PEEP on the basis of patients' individual response is warranted. Measurement of end-expiratory lung volume (EELV) by the nitrogen washin-washout technique, bedside available from recent ICU ventilators, has been shown to reliably estimate PEEP-induced alveolar recruitment and may therefore help titrate PEEP on patient's individual requirements. The authors designed an open-label, multicenter, randomized trial to test whether an individualized PEEP setting protocol driven by EELV may improve a composite clinical outcome in patients with moderate-to-severe ARDS.

NCT ID: NCT04009330 Active, not recruiting - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome

PHIND
Start date: November 22, 2019
Phase:
Study type: Observational

Patients prospectively classified to the hyper-inflammatory ARDS phenotype on the basis of clinical characteristics and a novel POC biomarker assay will have worse clinical outcomes than the hypo-inflammatory phenotype. Study Aim The purpose of this project is to prospectively identify hyper- and hypo-inflammatory phenotypes in patients with ARDS and determine clinical outcomes associated with each phenotype. The primary objective of this study is to assess the clinical outcomes in patients with ARDS according to their prospectively defined inflammatory phenotype determined using a POC assay. Results of group allocation will be blinded to clinical and research staff until database lock. Secondary Objectives The secondary objectives of this study are to: (i) Assess the agreement of the phenotype allocation using the POC assay and the clinical study dataset. (ii) Assess the stability of phenotype allocation over time (iii) To test feasibility of delivering a POC assay in the NHS intensive care setting.

NCT ID: NCT04000568 Completed - Prematurity Clinical Trials

Breathing Variability and NAVA in Neonates

BRAVe NANO
Start date: May 2, 2019
Phase:
Study type: Observational

The current study is a crossover trial, aiming at evaluating the effect of NAVA -NIV compared to Nasal Intermittent Positive Pressure Ventilation (PC-NIV) at the same level of peak inspiratory pressure, in terms of: breath-by-breath variability of tidal breathing amplitude, variability of the other breathing patterns; lung mechanics; gas exchange; rate of episodes of apnea; bradycardia and desaturations; respiratory asynchrony and comfort, in preterm infants < 37+0 weeks+days post-menstrual age.

NCT ID: NCT03984175 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Start date: July 8, 2018
Phase: N/A
Study type: Interventional

Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical ventilation protocols currently available in the investigator's Cerner electronic health record (EHR).

NCT ID: NCT03969992 Active, not recruiting - Clinical trials for Respiratory Distress Syndrome in Premature Infant

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.