Acute Respiratory Distress Syndrome (ARDS)

Researchers are evaluating whether the Breathlessness diagnostics in a Box (BiaB) tool can shorten the time to diagnosis for patients experiencing breathlessness compared to usual care. This prospective, interventional study uses a stepped-wedge cluster design in general practice settings across the Netherlands, Spain, and Portugal. The main goal is to see if BiaB speeds up diagnosis, with secondary aims to identify more cases of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), and to assess the tool's usability and efficiency. The study involves 45 general practice sites that start with a usual care period and sequentially transition to using the BiaB tool. Patients receive care as part of their regular visits, either through standard diagnostic procedures or with support from BiaB. No additional treatments are mandated by the study. Each site participates for 40 weeks, and data are gathered from routine clinical visits, electronic medical records, and questionnaires completed by patients and healthcare professionals. Participants attend a single study visit and may complete up to four quarterly questionnaires over a follow-up period lasting up to one year. Researchers measure the time from first presentation of breathlessness to diagnosis, the number of new COPD and CVD diagnoses, and the usability of the BiaB tool. Data are collected continuously during the usual care and intervention phases, allowing comparison of outcomes between these periods.

Researchers are evaluating the use of early near apneic ventilation compared to usual ultra-protective lung ventilation in patients with severe acute respiratory distress syndrome (ARDS) who are supported by venovenous extracorporeal membrane oxygenation (ECMO). The trial, named CALMDOWN, is a prospective, open-label, multicenter, randomized controlled study aiming to investigate whether early apneic ventilation can help reduce ventilator-induced lung injury, ECMO duration, and mortality by day 60 in this critically ill population. Participants are randomly assigned to one of two groups: one group receives near apneic ventilation during the first 3 days of ECMO using BIPAP/APRV or pressure-controlled ventilation with specific settings to maintain airway pressure and minimize ventilation rate. Neuromuscular blockade and sedation may be used as needed. After 3 days, apneic ventilation may continue or switch to ultra-protective lung ventilation at the physician's discretion. The other group receives standard ultra-protective lung ventilation throughout ECMO support with defined ventilator settings. Prone positioning is allowed in both groups based on physician judgment. During the study, participants will be monitored closely for outcomes including mortality at day 60, need for lung transplantation, persistence of ECMO support, and days alive without ECMO from day 0 to day 60. Additional assessments cover mortality and other clinical outcomes up to day 90, duration of ventilation, ICU stay, hospital stay, and complications such as pneumonia, pneumothorax, and right ventricular function. The trial is sponsored by Assistance Publique - Hôpitaux de Paris and runs until May 2030.

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups: ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure (PEEP) up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

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 they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients' ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are evaluating new imaging techniques in adults aged 18 to 85 with lung diseases such as asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM). The study aims to develop tools for analyzing lung function and structure using hyperpolarized Xenon 129 MRI alongside pulmonary function tests. This research is supported by Western University, Canada. Participants will undergo a series of tests during a one to two-hour visit, including medical history review, vital signs measurement, full pulmonary function testing following American Thoracic Society guidelines, proton MRI, specialized 129-Xe MRI scans using chest coils, and a low-dose thoracic CT scan. The MRI procedure includes monitoring heart rate and oxygen levels, providing hearing protection, and offering supplemental oxygen as needed. These imaging and testing methods help assess lung ventilation, diffusion, and gas exchange. During the study visit, participants will complete pulmonary function tests such as spirometry, plethysmography, and diffusing capacity tests. They will undergo magnetic resonance imaging with hyperpolarized Xenon gas to visualize lung airways and anatomy, along with CT scans matched to MRI breathing maneuvers. Researchers will measure ventilation defect percent (VDP), apparent diffusion coefficients (ADC), and dissolved phase spectroscopy over five years. Participant safety is monitored throughout the visit, and the total study duration includes these assessments and follow-up measures.

Researchers are studying biomarkers from 129Xe gas exchange MRI to understand how they change with different medical interventions. The study focuses on interactions between 129Xe and red blood cells in the lungs. Participants include healthy volunteers and patients with conditions like interstitial lung disease, pulmonary hypertension, acute or chronic pulmonary embolism, anemia, polycythemia, and dyspnea. The study uses hyperpolarized xenon gas inhaled in multiple doses followed by breath holds, alongside oxygen administration. Participants are grouped by treatment: those undergoing transfusion or phlebotomy, patients receiving oxygen for lung-related conditions or healthy volunteers, and those recently diagnosed with acute or chronic pulmonary embolism. Treatments and responses are monitored at baseline and various follow-up points. Participants will undergo MRI scans to measure red blood cell transfer, chemical shifts after oxygen delivery, and changes in red blood cell signal oscillations before and after treatment. The study includes visits up to 3–6 months after interventions to track changes. Researchers also monitor safety and participant adherence throughout the study, which lasts until mid-2028.

Researchers are evaluating the effect of starting Airsupra inhaler treatment in emergency departments (ED) on reducing acute asthma recurrence and other related outcomes over three months. The study focuses on adults aged 18 to 54 who visit the ED for asthma exacerbations and are discharged with a short course of systemic corticosteroids. This trial is a cluster randomized, open-label study comparing Airsupra use to usual care across multiple centers. Participants will be assigned by site to either receive usual care or Airsupra as their rescue inhaler along with corticosteroids. Airsupra dosing is as needed, with up to six doses per day. The study will run for about four to five months of enrollment per site, with follow-up assessments conducted at approximately 3, 6, and 12 weeks after the ED discharge to monitor asthma control, relapse, and recurrence. During the study, patients will complete interviews and chart reviews in the ED, and follow-up will include telephone or text contact to assess their clinical status and medication use. Medical records from before and after enrollment will be reviewed to identify asthma exacerbations. The main outcome is asthma recurrence within three months, with asthma control and early relapse also measured. Participants’ data will be securely managed throughout the study period, which extends up to 12 weeks post-ED visit.

Researchers are studying patients with severe pneumonia admitted to the Respiratory Intensive Care Unit (RICU) to understand the epidemiology and clinical characteristics of pneumonia caused by various factors. This observational cohort study aims to gather detailed clinical data including morbidity, mortality, risk factors, symptoms, and radiographic changes to help improve clinical care for severe pneumonia patients. The study involves patients admitted to the RICU due to pneumonia from any cause. There are no specific treatments or interventions being tested, as this is an observational study collecting data during the patients' stay. Researchers will observe respiratory support parameters, treatment options, and symptom developments during the initial days and weeks of hospitalization. Participants will be monitored for outcomes such as mortality and morbidity during their time in the RICU, with measurements taken over one year. Data on symptoms within the first 48 hours, respiratory support during the first 5 days, and treatments over 3 weeks will be collected. The study records clinical information to better understand pneumonia in this critical care setting, with participant involvement lasting as long as their hospital stay and follow-up for outcomes.

Researchers are conducting a clinical study to develop an artificial intelligence (AI)-based clustering model to personalize medicine for patients with acute respiratory failure who are admitted to the intensive care unit (ICU). The study aims to confirm patient phenotypes and compare clinical characteristics and prognosis between patients requiring advanced oxygen support and a control group without acute respiratory failure. Participants are divided into two groups: those with acute respiratory failure requiring treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or mechanical ventilation (MV), and a control group who do not need these treatments. Both groups are admitted to the internal medicine ICU at Samsung Seoul Hospital and undergo the same research procedures. During the study, participants' clinical information is collected prospectively for analysis. Researchers will assess hospital mortality up to one year from admission, ICU mortality up to six months, and length of stay in both hospital and ICU. The study involves monitoring patients from admission until discharge or death, with follow-up periods varying up to one year. This observational study is sponsored by Samsung Medical Center.