Clinical trials

The goal of this clinical trial is to evaluate the performance and physiological effects of different preoxygenation devices in healthy adult and pediatric volunteers (children aged 5-12 years). The study aims to determine how these devices influence oxygen delivery, airway pressure, and cardiopulmonary physiology during preoxygenation. The main questions it aims to answer are: * What fraction of inspired oxygen (FiO₂) is delivered by non-rebreather masks (NRM) compared to bag-valve masks (BVM) with and without positive end-expiratory pressure (PEEP)? * How do these devices differ in terms of generated PEEP, inspiratory effort, and their effects on lung ventilation and cardiac function? Researchers will compare NRM, BVM without PEEP, and BVM with PEEP (each with or without supplemental oxygen via nasal cannula) to evaluate differences in oxygenation and physiological effects. Participants will: * Complete multiple 3-minute preoxygenation sessions using each device in randomized order * Breathe spontaneously through each device, with or without additional oxygen via nasal cannula * Undergo non-invasive monitoring of oxygen concentration (FiO₂), respiratory parameters, airway pressures, and ultrasound assessment of the lungs, diaphragm, and heart * Perform a brief breath-holding maneuver to assess airway pressure generation

This prospective observational study aims to identify simple external anatomical landmarks that allow reliable prediction of correct esophageal probe insertion depth. Accurate placement in the lower third of the esophagus is essential for reliable core temperature monitoring. Transesophageal echocardiography (TEE) will be used as the reference standard to confirm correct probe position. The study will evaluate the agreement between landmark-based insertion depth and TEE-confirmed placement in adult ICU patients undergoing clinically indicated TEE.

The goal of this observational study is to learn whether intravenous iloprost treatment for severe frostbite (grades 3-4) is feasible and safe when delivered in pre-hospital, remote high-altitude settings. The main questions it aims to answer are: * Is it feasible to initiate and deliver guideline-based intravenous iloprost for grade 3-4 frostbite at high altitude and what logistical barriers arise? * Does field-based initiation of iloprost increase tissue preservation and reduce amputations (compared to historical cases from similar settings)? Participants receiving Iloprost as part of a frostbite treatment will be followed up after discharge as well as 6, 12 and 18 months to assess tissue preservation and long-term sequelae from the initial frostbite injury.

Study Objective and Hypothesis The study hypothesizes that artificial intelligence (AI)-assisted interpretation of the 12-lead electrocardiogram (ECG) can improve the care of patients resuscitated after out-of-hospital cardiac arrest (OHCA) by enabling faster and more accurate detection of occlusion myocardial infarction (OMI). This enhanced diagnostic approach could reduce the time required for revascularization, improve patient outcomes, and decrease unnecessary activations of cardiac catheterization laboratories. The primary objective of the study is to assess the effectiveness of an AI-powered ECG model in identifying acute OMI in OHCA patients whose post-return of spontaneous circulation (ROSC) ECG does not show ST-elevation. Methods This is a retrospective observational study involving OHCA patients in Bolzano, Italy, who meet the following inclusion criteria: Aged 18 years or older. Achieved ROSC after cardiac arrest. Underwent coronary angiography (CAG) within seven days post-OHCA. Prehospital post-ROSC ECG and CAG reports available. Exclusion criteria include in-hospital cardiac arrest (IHCA), traumatic cardiac arrest, cardiac arrest from a non-cardiac cause, and poor-quality or corrupted ECG images. Post-ROSC ECGs will be analyzed using the PMcardio App, an AI tool for ECG interpretation. The data will be fully anonymized before storage. Coronary angiography charts will be reviewed for the presence of atherosclerotic lesions, the degree of arterial narrowing, and Thrombolysis in Myocardial Infarction (TIMI) flow, which assesses blood flow in coronary arteries. Study Outcomes The primary outcome is the sensitivity and specificity of the AI-assisted ECG in detecting OMI in patients whose post-ROSC ECG does not show ST-elevation. Secondary outcomes include the frequency of OMI in OHCA patients without ST-elevation and the ability of the AI model to rule out OMI accurately in these cases.

Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers. Study endpoints Primary Endpoint: Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. Secondary endpoints: * Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. * Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT) * Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5 * Time to reaching an Oxygen Reserve Index (ORi) =1 * Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions. Number of participants 15 participants per subgroup, i.e. 45 participants in total. Inclusion criteria * Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II * Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3 * Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day. After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow.