Hypoxia

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 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.

Opioid overdose deaths have reached record highs in the United States, especially among patients discharged from emergency departments (ED). This research aims to evaluate a bundled intervention combining telehealth, peer support, buprenorphine treatment, and linkage to addiction programs to increase treatment uptake, reduce repeat opioid overdoses, and lower mortality in patients with opioid use disorder (OUD) after ED discharge. The study is supported by the HEAL Initiative and focuses on patients with recent opioid overdoses who face barriers to treatment after leaving the ED. The study includes two phases. In phase 1, 30 patients discharged from the ED will receive daily peer support via telehealth during the first week, then less frequently over 12 weeks, alongside buprenorphine prescribed by physicians. In phase 2, about 160 participants will be randomized to either the same bundled intervention or usual care, which includes ED-initiated buprenorphine and referral lists but no ongoing peer support. The intervention lasts 3 months post-ED discharge, and participants in all groups will complete follow-up surveys at 1 and 3 months. Participants will be involved in baseline assessments, receive the intervention or usual care after ED discharge, and complete self-report questionnaires through electronic surveys at 1 and 3 months. Peer supporters will remind participants to complete surveys. The study will measure treatment retention, adherence to buprenorphine, and successful linkage to addiction treatment programs at 1 and 3 months after ED discharge. These outcomes will help assess the feasibility and impact of this bundled approach to reduce opioid overdose risks and improve care continuity.

This clinical trial studies the use of a linear cognitive aid app designed to help emergency medical service (EMS) teams respond to pediatric emergencies. Researchers want to see if this new tool is practical and well accepted by EMS teams in both urban and rural settings. The study compares current standard cognitive aids with the new linear cognitive aid during simulated critical resuscitation scenarios for children. Participants will be randomized into two groups: one using their current standard cognitive aids, and the other using the linear cognitive aid app. Each team will perform two high-fidelity, in situ simulations of critical pediatric resuscitation emergencies. The linear cognitive aid app offers minimal input, linear step-by-step guidance, tailored recommendations based on the patient’s age and scenario, and audio prompts timed to the resuscitation process. During the study, researchers will assess the time it takes teams to reach American Heart Association (AHA) technical milestones, teamwork quality, and participants' perceived cognitive load during each 10-minute simulation. The study aims to evaluate how well teams perform and how the different cognitive aids affect their experience. The trial is led by Beth Israel Deaconess Medical Center and includes adult EMS providers who speak English and are actively practicing.

Researchers are investigating the maximum safe dose of Levetiracetam (LEV) for treating seizures in newborns. This Phase IIb study focuses on infants with mild to moderate neonatal seizures, hypothesizing that the optimal dose is higher than the current 60 mg/kg. The research also explores LEV's safety, tolerability, and its effectiveness compared to the standard treatment, Phenobarbital (PHB). Participants initially receive 60 mg/kg of LEV. If seizures continue after 15 minutes, they may be randomly assigned to receive either higher doses of LEV (in increments up to 150 mg/kg total) or PHB treatment at 20-40 mg/kg. The study uses continuous video EEG monitoring to measure seizure activity and evaluate the treatments. The trial includes multiple phases and dose escalation to ensure safety and gather efficacy data. During the study, infants will undergo continuous EEG monitoring to assess seizure burden over 24 hours, with neurophysiologists reviewing the data. Researchers will track LEV blood levels, adverse events, seizure reduction, and long-term outcomes up to 8 years. The study also evaluates a seizure detection technology. Participation involves treatment administration, monitoring, and follow-up to assess safety and seizure control.

Opioid overdose causes significant global health problems, and while prevention and treatment programs exist, more efforts are needed to reduce deaths and complications. This research evaluates a novel smartphone-based volunteer first responder system integrated with national emergency call services to assist suspected opioid overdoses. The system aims to alert trained volunteers equipped with naloxone, an opioid antidote, to provide early treatment before emergency medical services arrive, potentially saving lives by reducing the time to naloxone administration. Volunteer responders, called naloxone-responders, will complete training in opioid overdose recognition, naloxone use, and first aid based on European and Swedish guidelines. They will also learn low-arousal communication techniques for interacting with overdose victims. Each responder receives a kit with two doses of nasal naloxone and will be registered on a dedicated responder smartphone app. The study includes a two-year pilot phase with one-year follow-up per participant, along with multiple sub-studies examining feasibility, safety, acceptability, mortality, and experiences of responders and overdose survivors. Participants will be monitored through questionnaires, app data, and medical records from dispatchers, paramedics, and hospitals. The primary outcomes include the number of successful naloxone responder alerts, responder acceptability, clinical outcomes of overdose victims, and safety experiences during alerts. Mortality rates before and after the trial will also be analyzed. The study runs from September 2025 to August 2027, assessing both short- and long-term effects of integrating volunteer responders with emergency medical dispatch.

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs score’s predictive ability. The total study duration extends until the end of 2026.

Researchers are exploring two strategies for setting pressure support levels in patients receiving pressure support ventilation (PSV) in intensive care units. The study focuses on adults with acute hypoxic respiratory failure who need mechanical ventilation. It aims to compare the traditional method based on tidal volume (VT) and respiratory rate (RR) with a newer method using the pressure muscle index (PMI), which may better reflect patient inspiratory effort. This pilot trial will examine clinical outcomes and how well clinicians adhere to these strategies to guide future larger studies. The trial involves two treatment periods at two centers using a sequential cluster crossover design. The first 4-week period uses the VT/RR-targeted pressure support settings, followed by a 4-week washout, then a 4-week PMI-targeted period. In the VT/RR group, pressure support is adjusted to keep VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths per minute. In the PMI group, pressure support is adjusted to keep PMI between 0 and 2 cmH2O. Both groups receive standard mechanical ventilation care, including sedation and analgesia management, with adjustments made twice daily during PSV. Participants will be monitored daily until weaning, death, discharge, or 28 days after randomization. Data collected include ventilator settings, respiratory and hemodynamic parameters, sedation and analgesia levels, and clinical outcomes such as duration of mechanical ventilation and mortality. The study also includes clinician surveys about the acceptability and feasibility of the PMI-based strategy. This comprehensive approach will help assess the practicality of PMI-targeted pressure support in critical care settings.

Researchers are evaluating the safety and performance of the MOBYBOX System, an extracorporeal cardiopulmonary support device, in patients experiencing cardiac, respiratory, or combined cardiorespiratory failure. The study aims to gather prospective data on how well the device works and its safety profile in real-world use for patients with severe conditions affecting heart and lung function. The MOBYBOX System is used in two configurations: veno-arterial for cardiac or cardiorespiratory failure and veno-venous for severe respiratory failure. The device provides extracorporeal support to help patients whose heart or lungs are failing. The study monitors device performance every 4 hours while patients are receiving extracorporeal membrane oxygenation (ECMO) with the MOBYBOX system and records serious adverse events within 24 hours. Participants will be closely observed during their treatment with the device, with assessments focusing on safety by tracking serious adverse events within 24 hours and mortality within 30 days. Device performance success is also recorded regularly during treatment. The study will continue to follow patients until December 2026, collecting data relevant to the device's safety and effectiveness in supporting heart and lung function in critically ill patients.

Researchers are evaluating the safety and effectiveness of IBI362 in adults with moderate-to-severe obstructive sleep apnea (OSA) who have a body mass index (BMI) of 28 kg/m2 or higher. This Phase III study involves multiple centers and compares IBI362 to a placebo to better understand its impact on OSA symptoms and related health measures. Participants will be randomly assigned to receive either IBI362 or a placebo through weekly subcutaneous injections. The IBI362 dosage will increase gradually over the initial 12 weeks, starting from 2 mg once a week for 4 weeks, then 4 mg once a week for 4 weeks, followed by 6 mg once a week for 4 weeks, and finally 9 mg once a week for 36 weeks. The study includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week follow-up period after stopping the study drug. Throughout the trial, participants will undergo regular assessments including sleep studies to measure apnea-hypopnea index (AHI), body weight, blood pressure, and sleepiness scales. Researchers will monitor changes from baseline in these measures at Week 48. The safety and adherence to treatments will be closely tracked, and a final follow-up will occur 12 weeks after treatment ends. Total participation spans approximately 64 weeks.