99 Clinical Trials for Various Conditions
The purpose of this study is to investigate a specific approach to patient care called a time-limited trial (TLT). This approach is sometimes used for people who develop critical illness and are cared for in an intensive care unit (ICU). A time-limited trial is a plan made together by medical teams, patients with critical illness (if they can take part), and their families or other important people helping to make their healthcare decisions. A time-limited trial starts with a discussion of the patient's goals and wishes. Then, a plan is made to use ICU treatments for a set period of time to give the patient the chance to recover. After this time, the patient's response to treatment will be reviewed to help guide what to do next. Medical teams consider this kind of plan when it is not clear if a patient can recover to a quality of life that is acceptable to them. With a time-limited trial, patients, families, and medical teams experience this uncertainty together. The main goal of this study is to find the best way to use TLTs for patients in the ICU who have trouble breathing and need mechanical ventilation to help them breathe. The hypothesis is that optimal time-limited trial delivery will reduce the time patients with acute respiratory failure spend in the ICU and will improve the intensive care unit experiences for their families and clinicians.
The purpose of this study is to: 1. Establish the feasibility and acceptability of a therapeutic robot, Paro, for critically ill patients admitted to the Pediatric Intensive Care Unit 2. Explore safety considerations related to infection control \[participant hospital-acquired infection (HAI) rates, screening for the presence of microbial contamination with real-time adenosine triphosphate (ATP) testing 3. Examine the therapeutic effect of Paro on patient psychological variables, physiological variables, and sedative and analgesic medication requirements.
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.
The goal of this study is to develop a non-invasive test to diagnose intensive care unit (ICU) acquired weakness that can be administered to both responsive and non-responsive patients. Study participation will involve the measurement of muscle fatigue during a single 30 minute session. Skeletal muscle will be stimulated with an FDA approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.
Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff.
The objective of this project is to create deep learning and machine learning models capable of recognizing patient visual cues, including facial expressions such as pain and functional activity. Many important details related to the visual assessment of patients, such as facial expressions like pain, 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, and impending clinical deterioration, often cannot be incorporated into clinical status. The study team will develop a sensing system to recognize facial and body movements as patient visual cues. As part of a secondary evaluation method the study team will assess the models ability to detect delirium.
Given the stress, exhaustion and close interface with death that Intensive Care Unit (ICU) health care providers face, this study will evaluate burnout rates in intensive care unit (icu) physicians, nurses and ancillary staff. Investigators will also study the effect on a bereavement card on these burnout rates
The purpose of this observational study is to collect prospective data on the occurrence of bacterial and viral pneumonia in the ICU setting. Current classification systems for pneumonia promote over treatment with antibiotics as they do not specifically recognize the presence of culture-negative and viral pneumonia. The investigators will collect data to determine if a novel pneumonia classification system can be developed that more accurately links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia, antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to clinical outcomes. Additionally, the investigators will collect data on the practice of antimicrobial stewardship in the ICU setting to determine if further improvements in antibiotic practices can be accomplished in the future.
BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is helping a patient breathe if he can't breathe on his own. Because of the mechanical ventilation, these patients also require some medication to help keep them calm. These are called sedatives or anxiolytics. The purpose of this study is to see if acupuncture can lower the amount of sedation and anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a medical procedure. Hair-thin sterile needles are inserted at specific points on the body. PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By using 'fake' acupuncture, no one other than the acupuncturists will know which group a subject is in. Subjects and the team do not get to pick which subject is in which group. Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a day for five days. Standard of care - Both groups will receive the standard of care while in the study. They will be mechanically ventilated and given sedatives and analgesics based on the TICU protocol. Real acupuncture group - This group will receive real acupuncture with real needles. These are stainless steel, one time use, needles. This group will also receive "ear tacks" which are like little needles that can stay on the ear for a few days. The ear tacks will be covered with a bandage so no one can tell which group the subject is in. Sham acupuncture group - This group will receive sham needles. These needles retract into themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will not get ear tacks. In order to hide the group the subject is in, a bandage will be used to cover part of the ear. HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when compared to the sham acupuncture group.
This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. The investigators will monitor for safety, and will measure the amount of delirium experienced by subjects, record the amount of sedating and painkilling medicines required, and measure sleep quality during the study, among other information. The investigators will also measure noise levels experienced by patients in each group. The investigators predict that the use of overnight noise reduction will be safe and will reduce the amount of delirium by improving the quality of sleep in critically ill patients.
The purpose of this study is to evaluate and compare outcomes of patients that have received care in medical intensive care units in a tertiary care facility with two different models; the traditional model including resident, pulmonary fellow and attending physician and a nontraditional model which has Nurse Practitioners as the direct care deliverer, a pulmonary fellow, and an attending.
The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.
Delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. This form of organ dysfunction occurs in up to 50% of hospitalized patients and is associated with worsening mortality, prolonged hospital length of stay, higher health care costs, and accelerated functional and cognitive decline. Despite the negative consequences of delirium, the majority of cases are unrecognized by hospital physicians because it is not routinely screened for. In an effort to facilitate delirium screening, we sought to validate two brief delirium assessments (\<2 minutes) in the hospital setting.
The primary goal of this project is to determine whether normalizing hyperglycemia is a safe approach to improve multisystem organ function in critically ill children requiring intensive care. The will are conducting the "PedETrol" (the "Pediatric ICUs at Emory-Children's Center Glycemic Control: The PedETrol Trial) Trial, a 4-year single-center, prospective, randomized clinical trial to evaluate the outcome benefit, safety and resource utilization impact of maintaining strict glucose control in children with life-threatening conditions. \*\*\*This study is supported by an Research Project Grant (RO1 grant) (MRR) via the National Heart, Lung, and Blood Institute (NHLBI).
The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.
The primary aim of the study is to demonstrate the value of a preemptive approach to ethics consultation in an ICU. The investigators hope to answer the question: Will proactive ethics interventions by a skilled and experienced ethicist, participating in treatment discussions with physicians and nurses, as well as discussions with patients/surrogates, improve the quality of ICU care experienced by patients requiring prolonged treatment in the ICU (5 days or longer) by increasing their perceived quality of care and reducing the length of stay in the ICU by non-survivors? The study is a randomized trial of the use of an ethics consultant to address latent or manifest ethical issues in patients who remain in the ICU for five days or more, as compared to usual care. The investigators are testing the hypothesis that expanding the role of ethics consultations in the ICU to make them proactive will improve the process and outcomes of patient care by shortening the length of stay in non-survivors, and reducing suffering and unwanted and/or unnecessary aggressive treatments.
The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are: * screening on admission followed by isolation of MRSA+ patients * screening on admission followed by isolation and decolonization of MRSA+ patients * universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures. The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.
Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital costs greater than $30,000 United States. Patients with ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and reduced health-related quality of life, all of which may contribute to prolonged hospitalization and increased costs. Mechanistically, it is understood that patients with ARF demonstrate acute inflammation which may contribute to the above cited problems. While the investigators' research and that of others has shown that rehabilitation therapy can increase functional outcomes while lowering biomarkers of inflammation in the frail aged and other clinical populations, it is not known whether such rehabilitation therapy can result in improved functional capacity and functional performance and reduce inflammation in ARF patients. There is previous evidence for the feasibility and safety of rehabilitation therapy in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326 patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and administered throughout the hospitalization versus usual care (control). Standardized Rehabilitation Therapy will consist of: passive range of motion, physical therapy and progressive resistance exercise (strength training). The regimen will be administered 7 days/week by a Mobility Team consisting of a critical care nurse, physical therapist and nursing assistant. The investigators will determine whether standardized rehabilitation therapy will reduce hospital LOS, improve functional capacity and performance, improve quality of life, reduce inflammation and reduce hospital costs as compared to usual care. This study's primary objective is to determine whether standardized rehabilitation therapy will decrease hospital length of stay. Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital length of stay for patients with Acute Respiratory Failure.
This study will be a retrospective electronic medical chart review of all patients admitted to adult intensive care medicine units (ICU) at The Nebraska Medical Center over a three-year period from January 2006 through December 2008. The study will have three primary aims: * Aim 1: Determine correlates (qualifying criteria) of patients initiated on enteral versus parenteral PPIs as first choice in ICU and after discharge from ICU, * Aim 2: Based on correlates determine number of patients receiving parenteral PPIs that could receive enteral therapy as first choice in ICU and after discharge from ICU, * Aim 3: Estimate the potential savings in drug costs associated with conversion of eligible patients from parenteral to enteral PPI therapy with emphasis on lansoprazole solutab in the ICU and conversion of eligible patients requiring continued AST from parenteral to enteral PPI therapy after discharge from ICU.
The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation.
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.
Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal cost to ICU survivors who frequently experience significant cognitive impairment and an array of physical and functional disabilities that limit their recovery and quality of life. While the problems experienced by these patients are likely amenable to rehabilitation, few ICU survivors receive focused rehabilitation following hospital discharge. The purpose of this study is to initiate and test the feasibility of a complex intervention incorporating a cognitive, physical, and functional rehabilitation program at the time of hospital discharge and implement this 12 week program using in-home visits and tele-technology. We hypothesize that this interdisciplinary rehabilitation program, initiated at hospital discharge and implemented using in-home visits and tele-technology, will result in improved recovery of neuropsychological and physical performance and overall functional status.
To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.
Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Members of both the surgical and anesthesia team explain the purpose of each procedure and all issues associated with the procedures in great detail in order to better prepare the patient, ease their anxiety and aid their recovery. The underlying assumption for past investigations into overall patient satisfaction has been that the stressors inherent in the experience of illness and hospitalization have an adverse effect on patient recovery and can possibly prolong the recuperative process. Previous studies have shown that the specific performance of a team in regard to the effects of the stressors on the patient's status is key to providing optimal patient care in the ICU environment. Since the ICU stay is a difficult experience in the life of a patient, stressor predictability might allow for better physical and psychological conditions for the patient's recovery. Although there is a myriad of published research available on the potential stressors related to an ICU stay, there is a dearth of investigation into the inherently more intense circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By examining the stressors in the CT-ICU changes can be made by the medical care team and/or hospital that can ultimately enhance the patient experience in the CT-ICU. The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.
The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.
A growing body of evidence suggests hyperglycemia is associated with adverse outcomes in patients with and without diabetes. Observational studies document an association between hyperglycemia and poor clinical outcomes in cardiothoracic surgery, elective surgery, myocardial infarction, stroke. Randomized studies indicate glycemic control is associated with improved outcomes in diabetic patients with critically illness. Hyperglycemia is a recognized and common complication of patients receiving total parenteral nutrition (TPN). Few studies in the literature have looked into the impact of TPN-associated inhospital complications and mortality. Accordingly, this study aims to evaluate the impact of hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay, and mortality) in patients receiving TPN. We will perform a retrospective chart review of all patients treated with TPN from 1/01/06 to 12/31/06 at Grady Memorial Hospital. We hypothesize that patients receiving TPN who develop hyperglycemia experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay) and mortality compared to TPN patients with euglycemia. The results of this study will help us to formulate a prospective randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized patients. This study aims to evaluate the impact of hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay, in hospital mortality) in patients receiving total parenteral nutrition. We will perform a retrospective chart review of all patients admitted to the hospital receiving TPN from 1/01/06 to 12/31/06 at Grady Memorial Hospital. The results of this study will help us to formulate a prospective randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized patients.
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.
The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and analgesic medications) in ICU patients. The investigators will quantify the independent contribution of these risk factors to the incidence of long-term cognitive impairment, controlling for other established risk factors including age, pre-existing cognitive impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these modifiable risk factors will pave the way for the development of preventive and/or treatment strategies to reduce the incidence, severity and/or duration of long-term cognitive impairment and improve functional recovery for patients with critical illness.
The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium