Ventilator

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 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 phase 2a, multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial to study patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). The study aims to identify safe and well-tolerated doses and assess the pharmacokinetics (PK) of the drug OMN6 in these patients. This research evaluates how OMN6 behaves in the body and its safety when added to standard therapy. Participants will be randomly assigned to one of two groups: one receiving OMN6 along with standard antimicrobial treatment using meropenem and colistin, and the other receiving a placebo combined with the same standard treatments. OMN6 is given as three intravenous infusions of either 50 mg, 100 mg, or 150 mg each, administered over three hours, all delivered on a single day. The background treatment with meropenem and colistin continues for 7 to 14 days. The study compares safety and PK profiles between these groups. During the trial, participants will be monitored for safety over 28 days following treatment. Pharmacokinetic measurements like the maximum concentration (Cmax), time to maximum concentration (Tmax), area under the curve (AUC), and half-life (t1/2) of OMN6 will be assessed within one day of dosing. Safety evaluations include observing adverse events and other clinical parameters. This thorough monitoring will help researchers understand OMN6's safety and behavior in patients with HABP or VABP caused by ABC, with the study expected to continue until March 2027.

Researchers are evaluating the safety and effectiveness of a single intravenous dose of agenT-797 combined with standard of care (SOC) compared to placebo plus SOC in adults with severe pneumonia and moderate to severe acute hypoxemic respiratory failure (AHRF). The study aims to reduce short-term mortality in this patient group and is conducted in two parts: an initial Run-in Phase and a Phase 2 randomized, double-blinded phase. All participants receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS). In the Run-in Phase, participants receive open-label agenT-797 plus SOC to help characterize the baseline population. After this phase, participants are randomized to one of two groups in Phase 2: agenT-797 plus SOC or placebo plus SOC. Both treatments are given as intravenous infusions, and SOC includes antimicrobial therapy and corticosteroids following guidelines. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, days without oxygen support or ventilator use, time to resolution of hypoxemia, ICU-free days, infections, antibiotic-free days, and time to hospital discharge. Additional measurements include mortality at Day 90 and changes in cytokine profiles at baseline and on Days 3, 7, and 14. The study includes safety monitoring and assessments throughout the trial period, which is expected to end in August 2027.

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 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.

This research aims to develop a new ultrasonographic method to measure regional pulmonary strain in patients who have lung diseases and are receiving mechanical ventilation in an intensive care unit. Mechanical ventilation, while often necessary, can sometimes cause lung injury due to excessive strain or overdistension, especially in patients with severe lung conditions. The study intends to collect initial data on local pleural strain to assist in planning larger studies and potentially help prevent ventilator-induced lung injury. The study involves using lung ultrasonography to image the pleura at four specific locations on the chest in mechanically ventilated patients. The imaging will be performed using a Terason device with a 12L5 linear ultrasound probe, positioned perpendicularly to the pleura. Three consecutive breathing cycles will be recorded at each site. An experienced ultrasonographer and a technician will analyze the images using an algorithm to calculate various pulmonary strain measurements. Participants will undergo lung ultrasound imaging during their ICU stay, with images taken at four predetermined sites on the chest. Researchers will measure several strain components such as lateral and axial deformation and shear using specialized software. The primary outcome is the average absolute lateral deformation measured on the first day. Other measurements include various deformation ranges and shear values. The study's total duration for each participant is based on data collected during Day 1 of their ICU ventilation period.

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.

Many newborn babies experience breathing difficulties that require intubation, a procedure where a tube is inserted into the windpipe to help with breathing support. This trial compares two methods used by doctors to perform intubation: the traditional direct laryngoscopy (DL), where doctors look directly into the baby's mouth with a standard laryngoscope, and video laryngoscopy (VL), which uses a camera and screen to view the windpipe. The study aims to determine if VL leads to more successful first attempts without causing drops in oxygen levels or heart rate compared to DL. The trial uses a stepped-wedge cluster randomized design across multiple hospitals. Initially, each hospital uses the standard DL method for intubation. At randomly assigned intervals, hospitals switch to using the VL device, the C-MAC video laryngoscope, which includes a monitor and special blades. Doctors receive training and practice with this device before switching. Other intubation practices, such as drug use and supplemental oxygen, remain the same throughout the study. Participants in the trial are newborn infants undergoing intubation. Researchers will collect information about intubation attempts, including success rates, oxygen levels, heart rates, and any complications like oral trauma or need for chest compressions. The main outcome is whether babies are successfully intubated on the first try without physiological instability within five minutes. Additional measures include procedure time, number of attempts, and adverse events. Data will be compared between the periods using DL and VL to assess effectiveness and safety over the course of the study, which lasts until August 2026.

Lung cancer is the leading cause of cancer deaths in the UK, often diagnosed late. Current screening mainly targets high-risk groups, missing about 30% of cases, including many women and never-smokers. There is a need for a simple, non-invasive test to help triage patients with persistent respiratory symptoms who do not meet current screening criteria. The Inflammacheck4 device measures hydrogen peroxide and other breath markers linked to airway inflammation and oxidative stress. Previous studies showed it could distinguish lung cancer from other respiratory diseases well. This study aims to validate and improve the AI model behind Inflammacheck4 for quick and accurate lung cancer triage in NHS settings. This is a multi-center, observational study without intervention or randomization. Participants include healthy volunteers and people with lung cancer, suspected lung cancer (negative biopsy), pneumonia, non-malignant airway diseases, or other respiratory conditions. The study collects exhaled breath samples using Inflammacheck4 alongside demographic and clinical data. The AI model will be refined by analyzing these breath biomarkers across the different groups. The study includes both retrospective and prospective data integration. Participants will provide breath samples and allow access to clinical data and imaging results. The primary outcome is to refine the AI-based diagnostic model from enrollment until study completion in December 2026. Participants must be able to understand English and perform the breath test. The study excludes those with active infections (other than pneumonia), recent major lung surgery, recent cancer treatments, pregnancy, or recent smoking or certain medication use. The total participation time depends on individual enrollment and data collection timing.