Acute Respiratory Distress Syndrome (ARDS)

Researchers are evaluating the Breathlessness diagnostics in a Box (BiaB) tool to see if it can shorten the time to diagnose the cause of breathlessness in patients. This study uses a prospective stepped-wedge cluster design in general practice settings across the Netherlands, Spain, and Portugal. The goal is to compare usual care with the BiaB intervention, also assessing if BiaB increases diagnoses of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), as well as its usability and efficiency. The study involves 45 general practice sites, each participating for 40 weeks. All sites begin with a usual care period and then sequentially switch to the BiaB intervention period following a predetermined schedule. The BiaB tool supports healthcare professionals during routine clinical care by aiding in the assessment of patients presenting with breathlessness. Participants have a single study visit and may complete up to four quarterly questionnaires over a maximum follow-up of one year. Data are collected during routine visits, from electronic medical records, and through questionnaires completed by patients and healthcare professionals. The main outcome measured is the time from first consultation with breathlessness to diagnosis, tracked for up to 40 weeks per site.

Researchers are evaluating the effects of early apneic ventilation compared to usual care with ultra-protective lung ventilation in patients with severe acute respiratory distress syndrome (ARDS) who require venovenous extracorporeal membrane oxygenation (ECMO). This Phase 3, open-label, multicenter trial aims to examine whether early apneic ventilation can reduce lung injury, shorten ECMO duration, and lower mortality at 60 days in this critically ill population. Participants are randomized to receive either ECMO plus near apneic ventilation or ECMO plus ultra-protective lung ventilation. Near apneic ventilation is applied during the first three days of ECMO using BIPAP/APRV or pressure-controlled ventilation, with specific settings to maintain airway pressures and low respiratory rates. After three days, apneic ventilation may continue or standard ultra-protective ventilation is used. The ultra-protective lung ventilation group receives low tidal volume and pressure ventilation settings until ECMO weaning. Prone positioning during ECMO is allowed at the physician's discretion in both groups. Throughout the study, researchers monitor mortality, need for lung transplantation, ongoing ECMO support, and days alive without ECMO up to day 60. Participants undergo clinical assessments and ventilator management according to the assigned strategy. Consent procedures accommodate emergency inclusion with surrogate consent when needed, and follow-up includes evaluation of lung recovery and survival outcomes over the 60-day period.

Researchers are investigating lung mechanics in patients undergoing mechanical ventilation, focusing on the early phase from the start of ventilation until extubation. The study aims to better understand lung elastic properties and transpulmonary driving pressure using a non-invasive method called the PEEP-step method. This method measures changes in lung volume with varying end-expiratory pressure, which may help tailor ventilator settings to reduce lung injury. The research includes both intensive care patients with acute lung failure and lung-healthy patients undergoing general anesthesia for surgery. The PEEP-step method involves adjusting the positive end-expiratory pressure (PEEP) up and down in one or two steps while monitoring tidal volume and pressure changes using standard ventilator equipment linked to specialized software. This allows calculation of lung compliance and transpulmonary driving pressure without invasive esophageal pressure measurements. Measurements are taken before, during, and after respiratory treatment in intensive care units and operating rooms, including during surgery and anesthesia. The study is observational and longitudinal in design. Participants will be monitored continuously, with data collected from ventilator settings, blood gas analyses, and clinical monitoring equipment connected to a laptop for data analysis. Lung elastance changes are tracked throughout the treatment, typically over an average of one year. The study assesses lung function to find the optimal PEEP level that minimizes lung stress and aims to improve ventilator care. Consent procedures involve informing surgical patients before their operation and obtaining surrogate consent for intensive care patients.

Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after an ICU stay. PICS includes new or worsening physical, cognitive, and emotional difficulties that affect daily life, independence, memory, mood, and quality of life. The study also compares training on the standard ABCDEF care bundle with an expanded A-Z care bundle to see if the broader approach offers additional benefits in preventing PICS. The study involves a structured educational program for ICU teams, delivered through online courses, face-to-face sessions, checklists, pocket guides, and visual reminders. Two groups are trained: one on the classic ABCDEF bundle and another on the expanded A-Z bundle, which adds care aspects like nutrition, sleep, infection prevention, safety, discharge planning, and psychological support. At least 75% of staff in each ICU complete the training. After training, ICUs continue usual care while applying the trained care bundles and documenting adherence. Participants are adults who have stayed in the ICU for at least 48 hours and survived hospital discharge. They will be followed up at 1, 3, 6, and 12 months after discharge through tests and questionnaires about physical health, cognition, mood, and quality of life. The main measure is the presence of PICS three months after discharge. The study also monitors adherence to care practices and compares outcomes before and after training, as well as between the two training groups.

Researchers are investigating the long-term effects of reducing household air pollution (HAP) on heart, lung, and immune system health among women and children in semi-rural Bangladesh. Nearly 3 billion people worldwide, including 89% of Bangladesh's population, are exposed to harmful pollutants from burning biomass fuels like wood and cow dung for cooking. This study evaluates whether a mobile phone–based behavioral change communication (mHealth BCC) intervention can encourage exclusive use of cleaner fuel, specifically Liquid Petroleum Gas (LPG), and how this reduction in air pollution affects subclinical cardiovascular, pulmonary, and immune outcomes over time. The study uses a large household-level randomized controlled trial design where participants receive educational messages and notifications through a mobile phone app to promote LPG use. The frequency of messages varies based on participant responses, and usage is monitored by tracking engagement with educational materials. The study continues to assess personal and area air pollution exposure through detailed 24-hour and 5-day monitoring periods. Assessments include lung function tests, chest imaging, blood pressure, EKG, and blood tests for metabolic and immune markers, conducted before and two years after the intervention. Participants are followed over two years with repeated evaluations of personal and ambient air pollution levels, lung and heart function, and immune responses including vaccine antibody production. The study carefully monitors changes in inflammatory and immune cell function alongside cardiovascular and pulmonary health indicators. These comprehensive measurements aim to understand the health impacts of sustained HAP reduction achieved through behavioral change and exclusive LPG use.

Researchers are evaluating the use of hyperpolarized Xenon-129 (129-Xe) MRI alongside pulmonary function testing in adults aged 18 to 85 with diagnosed lung diseases such as asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, and other related conditions. The study aims to develop tools to assess lung function by measuring the Apparent Diffusion Coefficient (ADC), ventilation defect percent (VDP), and pulmonary gas exchange using 129-Xe MRI technology. Participants will undergo a one to two hour visit involving several procedures: a brief medical history and vital signs check, comprehensive pulmonary function tests including spirometry, plethysmography, and diffusing capacity measurement, proton MRI, specialized 129-Xe MRI using a 3T MR scanner with chest coils, and a low-dose thoracic CT scan. During the MRI, participants will wear hearing protection and have their heart rate and oxygen saturation monitored, with supplemental oxygen available if needed. The CT scan will capture high-resolution images of lung anatomy using the same breath-hold technique as the MRI. Throughout the study visit, participants will perform breath-holds and pulmonary function tests following standardized guidelines to ensure accurate measurements. Researchers will collect data on lung ventilation and structure, analyzing the ventilation defect percent as a primary outcome over five years. Safety measures include monitoring oxygen levels and heart rate during imaging. The study involves a single visit with detailed assessments to better understand lung disease using advanced imaging and physiological testing.

Researchers are studying three biomarkers from 129Xe gas exchange MRI to understand how they change after different treatments. These biomarkers focus on the interaction of 129Xe with red blood cells in the lungs, including RBC transfer MRI, heart-related oscillations in the 129Xe-RBC signal, and changes in the 129Xe-RBC chemical shift. The study includes healthy volunteers and patients with conditions such as interstitial lung disease, idiopathic pulmonary fibrosis, non-specific interstitial pneumonias, chronic hypersensitivity pneumonitis, sarcoidosis, chronic thromboembolic pulmonary hypertension, acute pulmonary embolism, anemia, polycythemia, and shortness of breath. Participants receive hyperpolarized xenon gas in doses up to 25% of their total lung capacity, followed by a breath hold of up to 15 seconds. Some patients will also receive oxygen therapy. Groups include healthy volunteers, patients scheduled for red blood cell transfusion or therapeutic phlebotomy, and those with lung or heart-related conditions. Patients with chronic thromboembolic pulmonary hypertension may have surgery and return 3 to 6 months later for follow-up scans. During the study, participants undergo MRI scans before and after treatments such as transfusion, apheresis, or oxygen administration. Researchers measure changes in red blood cell to membrane ratio, chemical shift after oxygen, and oscillation amplitude over time. The study monitors safety and participants' ability to hold their breath during imaging. The time frame includes assessments up to 5 days before and after transfusion or apheresis and follow-ups 3 to 6 months post-treatment.

Researchers are evaluating the effect of starting Airsupra inhaler treatment in the emergency department (ED) on acute asthma recurrence over 3 months. This phase 4, multicenter, randomized controlled trial focuses on adults aged 18 to 54 who visit the ED for acute asthma exacerbations and are discharged with a plan for short-course systemic corticosteroids. The study aims to see if Airsupra, which combines albuterol and budesonide, can reduce asthma relapses and improve asthma control compared to usual care. The trial will also explore outcomes in key subgroups based on demographics and prior asthma history. Participants at intervention sites will receive Airsupra as a rescue inhaler, with dosing up to 6 doses per day (2 inhalations per dose), alongside a short course of systemic corticosteroids. Usual care sites will manage patients per standard practice without Airsupra. All patients receive brief asthma education. Enrollment will last 4-5 months at 30 sites across the US, and patients will be followed for 3 months after their ED visit. During the study, patients will complete structured interviews and chart reviews at enrollment. Follow-up assessments by phone or text will occur around 3, 6, and 12 weeks post-ED visit to track asthma relapse, control using the AirQ questionnaire, medication use, and any side effects. Medical records for the year before and 3 months after enrollment will be reviewed to identify asthma outcomes. The main measure is asthma recurrence within 3 months, including urgent visits for worsening symptoms. Safety and asthma control will also be evaluated throughout the study period.

Since the appearance of Severe Acute Respiratory Syndromes (SARS) in 2003, many new types of respiratory viruses have emerged, changing the patterns and characteristics of severe pneumonia. This research follows a group of patients admitted to the Respiratory Intensive Care Unit (RICU) with severe pneumonia from various causes. The study aims to collect detailed clinical data to better understand pneumonia’s causes, symptoms, risk factors, and impacts on patients in the RICU setting. Participants in the study are patients admitted to the RICU due to pneumonia from any cause, with an expected hospital stay longer than 72 hours. The study observes these patients but does not test a specific treatment; it collects information about their clinical symptoms, radiographic changes, respiratory support parameters, and other relevant data to analyze pneumonia severity and outcomes. Throughout the study, researchers track outcomes such as mortality and morbidity within one year of RICU admission. Data collected include clinical features, treatment details, and respiratory support measures. The information aims to guide better clinical care for severe pneumonia patients in intensive care, based on the comprehensive analysis of their clinical course and complications over time.

Researchers are conducting a study to develop an artificial intelligence-based clustering model aimed at improving personalized medicine for patients with acute respiratory failure admitted to the intensive care unit. The study will compare clinical characteristics and prognosis between patients requiring oxygen support beyond a high flow nasal cannula and a control group without acute respiratory failure. This prospective cohort study is taking place at a single center, Samsung Seoul Hospital. Participants will be divided into two groups: those with acute respiratory failure receiving treatments like high flow nasal cannula, non-invasive ventilation (BIPAP or CPAP), or mechanical ventilation, and a control group without such oxygen therapy needs. Both groups will undergo the same research procedures for comparative analysis. The study focuses on collecting clinical information to identify distinct patient phenotypes through clustering analysis using AI techniques. During the study, researchers will monitor hospital mortality from the time of admission until discharge or death, up to one year. Participants will be observed in the internal medicine intensive care unit, and data on their clinical status and outcomes will be collected. This long-term monitoring aims to understand prognosis and improve treatment strategies for acute respiratory failure.