Critical Illness Clinical Trials

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness. Read Less

The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial arterial line (A-line) in critical care patients. Read Less

This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients. * Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding. * Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar. Read Less

More than 60% of intensive care unit (ICU) patients are adults ages 60 and older, who are at high risk for ICU-acquired cognitive impairment. After ICU discharge, ICU survivors often experience sleep disturbances and inactivity, and almost 80% of ICU patients experience disturbances in circadian rhythm, which may affect cognitive function. Understanding the optimal, chronotherapeutic timing of cognitive interventions is crucial to promote circadian realignment and cognitive function, and may improve intervention feasibility, acceptability, and efficacy. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention \[COG\]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care \[UC\]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function. Read Less

This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%). Read Less

This BRAIN-ICU-2 study \[Bringing to light the Risk factors And Incidence of Neuropsychological dysfunction (dementia) in ICU Survivors, 2nd Study\] is in direct response to PAR-17-038 and will determine ICU patients' main paths to decline, maintenance, or recovery of brain function. We will answer gaps in knowledge about long-term outcome of post-ICU brain disease by following the remaining ICU survivors from the original BRAIN-ICU-1 study with complete cognitive testing for the first time ever to 12 years (AIM 1). We will consent and enroll 567 new ICU patients at Vanderbilt and Rush Universities (i.e., BRAIN-ICU-2 cohort) and determine how detailed neuroimaging and cerebrospinal fluid samples can help reveal locations and mechanisms of injury beyond what we learned from the clinical information collected in our original study (AIM 2). Importantly, we are mirroring the existing world-renowned Rush Alzheimer's Disease Research Center brain bank program so that all patients enrolled in Aims 1 and 2 will able to donate their brains to science for the first-ever in-depth pathological study of those who do and do not get post-ICU dementia to define this disease formally (AIM 3) Read Less

This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older). Read Less

The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress. The main questions this study aims to answer are: Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress. Participants will: Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning. Provide demographic information (like age, gender, and diagnosis) from medical records. This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future. Read Less

This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish. Read Less

Traumatic injury followed by critical illness provokes pathophysiologic changes in the bone marrow and the gut that contribute to persistent anemia and changes in the microbiome which significantly impact long-term recovery. This project will define the interactions between the stress, chronic inflammation, bone marrow dysfunction, and an altered microbiome which will provide a strong foundation for future clinical interventions to help improve outcomes following severe trauma. Read Less

Important information related to the visual assessment of patients, such as facial expressions, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses, or are not captured at all. Consequently, these important visual cues, although associated with critical indices such as physical functioning, pain, delirious state, and impending clinical deterioration, often cannot be incorporated into clinical status. The overall objectives of this project are to sense, quantify, and communicate patients' clinical conditions in an autonomous and precise manner, and develop a pervasive intelligent sensing system that combines deep learning algorithms with continuous data from inertial, color, and depth image sensors for autonomous visual assessment of critically ill patients. The central hypothesis is that deep learning models will be superior to existing acuity clinical scores by predicting acuity in a dynamic, precise, and interpretable manner, using autonomous assessment of pain, emotional distress, and physical function, together with clinical and physiologic data. Read Less

This study aims to use mass spectrometry techniques to analyze exhaled patient breath in non-COVID ICU-admitted patients requiring ventilation for a rapid and accurate early detection of pulmonary diseases and inflammatory markers. Read Less