50 Clinical Trials for Various Conditions
This study investigates the association of blood transfusions given around the time of surgery (perioperative) with complications after surgery (postoperative), cancer progression, and mortality after major oncologic non-cardiac surgery. The administration of blood products is an important clinical therapy to treat life-threatening blood (hematological) disorders (i.e. anemia, coagulation disorders or thrombocytopenia) in patients with cancer undergoing major non-cardiac surgery. On the other hand, the unnecessary exposure of those patients to blood products can be associated with the occurrence of unwanted severe complications and potentially increase the risk of death. An accurate understanding of the short and long-term outcomes, the patterns of blood transfusions, and the triggers of blood product administration may help researchers design and test the safety of perioperative blood transfusions in patients with cancer.
The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy. This is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.
The United States is currently experiencing an explosive opioid epidemic. In 2014 alone, 28,647 Americans died from an opioid associated overdose; the annual death toll has increased by over 300% since 2000. The epidemic poses a complex scenario for physicians administering treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to severe pain. In order to reduce the patients risk for long term opioid use and the associated side effects, physicians have begun shifting to multimodal analgesic approaches to treat postoperative pain. These approaches have been found to be similarly efficacious, while also reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus. This study proposes a multimodal analgesic approach, which the investigators believe will reduce short and long term opioid usage, the associated side effects, and the financial burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive pain management, however its use is limited by a high cost to perceived benefit ratio. Oral acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV option, and also often not feasible to utilize in the immediate post-operative period when patients are unable to safely swallow pills. The hypothesis of this investigation is to understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar spinal surgery will result in improved pain management in the perioperative period while decreasing opioid usage and related complications.
1. The investigators will design, test and implement a education curriculum for anesthesia residents teaching geriatric anesthesiology. 2. The investigators will randomize 42 anesthesia residents so that half receive an innovative, e-learning curriculum while the other half receives the current standard curriculum. We will assess their medical knowledge, and the amount of anesthesia delivered to patients after the curriculum is implemented. 3. The investigators will analyze any changes in clinical practice of residents in the care of elderly patients. Enrollment will be voluntary for all residents. Also, the investigators will not interfere with clinical management of any patients by residents which are done under direct supervision of faculty.
This project is designed to assess the impact of pre-operative use of non-invasive hemodynamic monitoring technologies on improving peri-operative and post-operative care of moderate to high-risk surgical patients with poor functional status by improving the detection of reduced cardiovascular function.
This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.
The goal of this clinical research study is to collect information on patients who had or are going to have laparoscopy performed at M. D. Anderson. Researchers want to use this information to learn the effects of laparoscopic surgery on patients over time.
We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. Half of the participants will be randomly assigned to routine care (core temperature ≈35.5°C), while the other half will receive aggressive warming (\>37°C core temperature) in a multi-center trial.
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following cleft palate surgery in infants and young children.
The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care. The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need. The research team's goals are to: * Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials. * Determine if the intervention improves meeting presurgical criteria for vaginoplasty. * Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable. The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice. The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 260 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators from Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course. The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly. In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.
Patients with limited English proficiency (LEP) are at significant risk of receiving care different from those who are English proficient. Through Translating Anesthetic Care Throughout (TACT), the investigators aim to reduce the disparities experienced by participants with LEP undergoing anesthesia by continuing language translation from the preoperative area into the operating room, where participants will be better able to understand what is happening in an otherwise foreign environment. At this time, some participants receive translation in the preoperative area using an interpreter. No further translation is provided beyond the preoperative area unless there is a provider with language concordance or interpretation skills within the perioperative team. The investigators plan to study how extended translation changes a participant's understanding of and feelings about the perioperative period. Supporting language translation for LEP participants from the preoperative area into their operating room (OR) experience will enable providers to better understand how to care for participants from different cultural and language backgrounds and will help us understand how to better serve our community at large. The investigators hypothesize that participants who receive continual translation will have improved informed consent, have improved trust of their anesthesia providers, and be more satisfied with patient care. In addition, they anticipate that the care team also will benefit by the enhanced communication with the participant.
This randomized trial will study the effect of a mobile app that facilitates patient engagement (patients undergoing complex abdominal surgery will track metrics of interest to the surgeon, submit reports on their symptoms/pain/physical function, and upload wound images) on readmission to the hospital. This trial will also assess whether the app can impact surgical complication severity, number of emergency department visits, and readmission costs. 300 participants will be enrolled and can expect to be on study for 6 months.
Immersive virtual reality (iVR) has been used successfully to manage pain with distraction. It is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and NSAIDS are used, and has previously been used safely in place of analgesia during dressing changes and burn care. This study investigates whether iVR can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (PIV) catheters in adults.
The purpose of the study is to determine if teaching self-hypnosis techniques to patients prior to knee replacement surgery will decrease their pain medication requirements, pain medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety, physical function, satisfaction scores, and cost of admission.
Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.
Enhanced Recovery After Surgery (ERAS) protocols have been of increasing interest in the surgical community for decades. The emphasis has been development of protocols to maximize pain control post-operatively without the use of opioids. While this approach has been studied extensively in the oncology surgery literature, little data exists on the utility of ERAS protocols in the setting of breast conserving surgery (BCS), which is a type of surgery to remove breast cancer while saving as much of the breast as possible. The purpose of this study is to determine the utility of implementing ERAS protocols in breast cancer patients undergoing breast conserving surgery. Study participants will be randomized to either ERAS protocol or standard peri-operative care without ERAS. The study will assess the how many opioid prescriptions are given in the first week after surgery and how much pain participants report right after surgery. Investigators will also look at how long participants stay in the recovery room and if medicine for nausea is needed.
The study aims to assess the implementation and effectiveness of Integrative Treatments - Music Medicine, Aromatherapy, and Battlefield Acupuncture - in the management of perioperative pain and anxiety, and in the reduction of related pharmacologic treatments.
The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether the intervention reduces preoperative anxiety, improves patients' confidence and positive coping, improves caregivers' satisfaction and self-efficacy, and reduces call volumes from caregivers to the clinic after surgery compared to current standard care.
The purpose of this study is to find out if it is possible to use the automated geriatric co-management program to manage the participants care before, during and after surgery.
Neuromuscular blocking agents' (NMBA) use during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Residual neuromuscular block (rNMB) after surgery is difficult to identify. We have recently developed the REsidual neuromuscular block Prediction Score (REPS), that predicts the risk for postoperative rNMB. Our primary objective is now to assess the predictive ability of the REPS for respiratory complications within seven days following general anaesthesia. The secondary objective is to compare the predictive values of REPS and train-of-four (TOF)-ratio below 0.90 for respiratory complications.
The use of neuromuscular blocking agents during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Understanding the clinical behavior of providers is essential in devising and assessing quality improvement projects since it is primarily individuals who determine the utilization of neuromuscular blocking drugs and reversal agents, not institutions. Therefore, the primary objective of this study is to determine the variability between individual anesthesia providers (attending physician, resident, nurse anesthetists) in the use of neuromuscular blocking drugs and reversal agents, using advanced statistical methods to adjust for differences in patient and procedure case mix. The investigators hypothesize that variance between individual anesthesia providers in the use of neuromuscular blocking drugs and reversal agents differs depending on provider type.
In 2011, 38.6 million hospital stays occurred in the United States at a cost of $387.2 billion. 47.9 percent involved hospitalizations during which surgical procedures were performed. Orthopedic procedures constituted the most frequently performed and most costly of operating room procedures. As the healthcare climate in the United States continues to change, there is a trend towards providing effective care in a fiscally conservative manner. Central to this strategy is the shift towards increasing ambulatory surgical procedures from surgeries requiring post-operative admission for patients. While savings to hospitals and third-party payers are implied, there may be an unrecognized increase in financial, physical, and psychosocial post-operative costs to patients undergoing ambulatory surgery and to their caregivers. Rawal et al., and McGarth and colleagues have found that patients undergoing orthopedic procedures had moderate to severe post-operative pain. We propose to present a survey to patients and their caregivers before surgery and at multiple timepoints post-operatively to acquire information on the impacts of ambulatory orthopedic surgery. In addition to assessing post-operative pain, this study serves to examine various other possible burdens to patients that have not been previously evaluated in this patient population. REFERENCES McGarth B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have a moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J Anesth. 2004; 51:886-891. Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A. Survey of postoperative analgesia following ambulatory surgery. Acta Anesthesiol Scand. 1997; 41:1017-1022.
This study aims to assess the performance of presurgical clinic blood pressure measurements in predicting home blood pressure readings among surgical patients. It also aims to measure the association between home blood pressures and patient perspectives on blood pressure control.
This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients. Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.
This study will investigate the benefits of administering celecoxib (Celebrex), a selective cyclooxygenase -2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the management of post total knee replacement pain, and through the 6 weeks of physical therapy and rehabilitation.
The study hypothesis is that perioperative Auricular (battlefield) acupuncture for general surgery and urology cases undergoing general anesthesia will decrease opioid requirements, postoperative pain, the incidence of PONV, and the incidence of perioperative anxiety in comparison to simulated (placebo) perioperative battlefield acupuncture.
The study goal is to compare surgeon-palliative care team co-management, versus surgeon alone management, of patients and family members preparing for major upper gastrointestinal cancer surgery. The study also aims to explore, using qualitative methods, the impact of surgeon-palliative care team co-management versus surgeon alone management on the perioperative care experience for patients, family members, surgeons, and palliative care clinicians.
The overall purpose for conducting this research is to improve the safety and efficacy of care for perioperative patients who have developmental delays and behavioral challenges. The specific objectives for this study are to describe distress behaviors and interventions used in the ACT population. The investigators will also determine the relationship between a predictive measure of distress (the Psychosocial Risk Assessment in Pediatrics score) with the actual distress behaviors exhibited by patients in the perioperative area. This study will provide knowledge that is necessary in order to develop best practices and to guide future research for this patient population. Further understanding the techniques used to improve care in the perioperative setting may also provide useful information to consider in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.).
This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.
Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.