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This study is a cluster randomized trial across 10 hospitals, stratified by hospital size (hospitals with greater than 100 mechanically ventilated patients a year will be classified as large, while those with 100 or fewer will be classified as small). Randomization will occur at the hospital level, ensuring an even distribution of large and small hospitals between study arms. Hospitals assigned to the intervention group will implement an EHR-based strategy designed to enhance adherence to lung-protective ventilation (LPV) for a 9-month intervention period, after which the strategy will be rolled out to all hospitals. The intervention focuses on modifying the ventilator order within the Electronic Health Record (EHR) to encourage default settings aligned with LPV principles. This study design allows for comparison of patient outcomes before and after implementation within each hospital while also enabling simultaneous comparisons between hospitals that have and have not yet received the intervention. The cluster randomization approach is necessary, given the order is controlled at the hospital level.
Ventilator associated events (VAE) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the ICU. VAE have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. Operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. ICU teams are encouraged to follow best practice protocols to help liberate and prevent VAEs. Yet, compliance with protocols in most ICUs is suboptimal for multiple reasons. With the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (BMDI) such as Capsule (UTMB's BMDI system), software systems have been developed to help identify variances in the standard of care. Automation in near real-time ventilator data feedback has been shown to reduce the incidences of VAEs. This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated events (VAE), alarm policy compliance, ventilator weaning, and lung protective analytics. Goals: 1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis. 2. Provide the RKP tool to the ICU team to determine if the use of RKP's webportal and Messenger Zebra phone app improves quality of mechanical ventilation and outcomes. 3. To determine a return on investment (ROI) for a software system like RKP.
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).
The primary goal of this study is to investigate the comparative long-term (i.e., 1-year) effectiveness of energy recovery ventilators (ERVs) and portable air cleaners (PACs) in reducing indoor air pollutants and mold levels and improving asthma-related health outcomes in inner-city children and adults with asthma in low-income households in the Dallas-Fort Worth (DFW) metropolitan area, TX. Secondary goals include: (1) examining associations among asthma outcomes, exposure to indoor air pollutants and mold, and housing-related factors, (2) conducting a cost-benefit analysis of ERV and PAC interventions for improving IAQ, mold control, and health outcomes, and (3) evaluating the utility of cost-effective methods and protocols for measuring IAQ and mold for indoor air pollution epidemiology studies and for providing practical information to patients and their physicians. Using a double-blind, placebo-controlled randomized controlled trial, 80 households will be assigned to receive active or placebo versions of ERVs or PACs. Environmental exposures and housing conditions will be monitored alongside comprehensive health assessments, including lung function tests and validated surveys on asthma control, quality of life, stress, and sleep quality.
This is a pilot study to determine if pulmonary function (lung compliance and ventilation/perfusion matching) is improved using APRV during general anesthesia, compared to the standard CMV. APRV will be tested during anesthesia in 12 patients undergoing robotic-assisted gynecological or genitourinary surgical procedures for definitive cancer treatment, who will also receive CMV.
For patients requiring mechanical ventilation, spontaneous breathing trials (SBTs) are conducted to determine if it is safe to remove the breathing tube. There are multiple methods for conducting SBTs. The purpose of this study is to compare the effects of 2 methods, pressure support ventilation (PSV) versus automatic tube compensation (ATC), on successful extubation for critically ill adult patients who received mechanical ventilation for over 24 hours.
In this clinical trial, investigators want to learn more about using non-opioid pain medications for children with acute respiratory failure. Right now, doctors give these children opioids to help with pain while they are on the ventilator, but investigators don't know if this is the best way to manage their pain. Even with strong doses of opioids, more than 90% of these children still feel pain. Other pain medicines, like acetaminophen (also called Tylenol) and ketorolac (also called Toradol), are available but aren't commonly used because we don't know if they help. The goal of this clinical trial is to test if acetaminophen and/or ketorolac can improve pain control and reduce the need for stronger pain medications (opioids) in these children. To learn more about this, participants will be randomly placed in one of four study treatment groups. This means that a computer will decide by chance which group each participant is in, not the doctors running the study. Each group will receive a combination of intravenous acetaminophen, ketorolac or a harmless substance called a placebo. In this clinical trial, placebos help investigators see if the actual medications (acetaminophen and ketorolac) work better than something that doesn't contain medicine. By comparing participants who get the real medicine with those who get the placebo, investigators can find out if these medications effectively decrease pain.
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g., nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.