Clinical Research Directory

Time-limited Trials in the Emergency Department

A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department.

Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults

This is a prospective, observational, monocentric, phase II (exploratory) cohort study aiming to describe the evolutionary profile of the initial volume of glucose distribution (IDVG) during the first four days of management of severely burned patient.

Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers

This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers. In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.

Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients

This is a prospective interventional study examining the effect of ketorolac at doses of 15mg versus 30 mg for duration of analgesia in emergency department patients with suspected renal colic.

Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain

Low back pain accounts for billions of dollars in health care expenditures. Most cases of back pain do not have a clear cause. Thus, low back pain management methods usually rely on targeting people' pain and discomfort. Painkillers, including opioids, are usually prescribed in the emergency departments for people with low back pain. But, like all medications, painkillers can have side effects, and some of those can be serious. There are also serious concerns about the overuse of painkillers. Thus, newer pain management methods are needed to reduce the use of painkillers in people with low back pain. Lumbar braces are one of the underutilized low back pain management methods in the emergency departments. Like crutches for leg and ankle injuries, they can minimise movements of the spine. This may decrease people pain and improve their function. This may also reduce the use of painkillers. In support of this approach, two recent studies conducted in a primary-care setting observed a reduction in the use of painkillers in people with low back pain who wore lumbar braces. The investigators are conducting this study to determine if wearing a lumbar brace for 4 weeks following emergency department presentation will reduce people's pain and discomfort and increase spine function. This may decrease the use of painkiller and future use of healthcare resources. This research study may also assist emergency-department staff with offering new recommendations to improve the quality of clinical decisions.

Feasibility and Efficacy of Ambulance-Based m-Health for Pediatric Emergencies (FEAMER) Trial

Investigators hypothesize that in a low-resource setting, linking ambulances that transport acutely ill children to a remote pediatric emergency physician using a simple audio-video device will improve the quality of these children's medical decisions and health outcomes. For this purpose, the investigators will conduct a study in Karachi, Pakistan, where they will collect medical data for ill children at the time of ambulance pickup, hospital drop-off, and during hospital triage. During transport, one group will receive a telemedicine call from a trained physician, while the other group will receive basic paramedic treatment. The investigators will then compare both groups.

Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?

At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner. However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature. This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

Video Images About Decisions for Ethical Outcomes in the Emergency Department (VIDEO-ED)

A randomized controlled trial of a video decision aid in the Emergency Department Setting to improve advance care planning documentation.

Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization

This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.

Optimisation Strategy for Emergency Tracheal Intubation

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

Artificial Intelligence (AI) Support in Medical Emergency Calls

More than 12.000 patients suffer acute stroke in Norway every year, but less than half of them reach hospital within the current treatment window for thrombolysis. Stroke is the third-highest cause of death and the number one cause of severe disability requiring long time care at institutions. Consequently this has a high impact on society, patients and relatives, in addition to high costs related to care estimated to approximately 10 billion NOK per year. Although there are few studies on emergency medical communication centres (EMCC) in Norway, some have shown that the performance of the emergency medical communication centres can be improved. This project will seek to amend EMCC´s handling of acute stroke inquiries using artificial intelligence (AI), thus contributing to getting the patient to hospital in time for optimal treatments.

The RightCall: Implementing a Sepsis Diagnostic Toolkit to Improve Pediatric Diagnosis in ED Transfer Calls

Sepsis is a leading cause of death in children, and an early diagnosis that improves outcomes is less likely in children who are treated in general Emergency Departments (EDs), that treat adults and children, compared to pediatric Emergency Departments. The study team, in collaboration with invested clinicians and expert partners, has developed a pediatric sepsis diagnostic safety toolkit that we will implement in a pediatric health system's transfer call center. Preparation for launch of the toolkit will include education throughout Children's Hospital Colorado (CHCO), with a focus on transfer center nurses and accepting CHCO physicians who will be partnering in delivering the toolkit. Usual avenues for clinical education will be used, including meetings, endorsement from clinical leaders, emails, and physical materials such as badge and pocket cards. Referring Emergency Department (ED) providers outside of CHCO will not receive education about the toolkit by design, since they are the recipients of the toolkit which is designed to disseminate sepsis diagnostic knowledge in real time to general EDs within existing transfer workflows. This research will test whether the toolkit improves early pediatric sepsis diagnosis in general EDs where most children receive their first critical hours of care.

Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch

The goal of this single center prospective observational study is to determine the effect of chemotherapy on (the change in) vital parameters. The main question it aims to answer are: Can changes in vital parameters be measured by using a Fitbit in patients with cancer while undergoing chemotherapy. Participants will be asked to wear a Fitbit for the first two cycles of chemotherapy to evaluate the changes in vital parameters.

Simulation Trial of Telemedical Support for Paramedics

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review

High-Sensitivity Troponin I in Addition to Guideline-Based Care in EMS

The TIGER study is a study investigating the utlility of a point-of-care blood analyse of Troponin I to help identify patients with heart attacks in the prehospital emergency care. The study is conducted within the ambulance services of Region Stockholm and compares standard medical care with and without the addition of this quick test. Chest pain is one of the most common reasons for ambulance dispatch, but currently only about one-third of heart attacks are detected before arriving at the hospital-mainly through ECG. The remaining two-thirds are not identified until after further testing at the emergency department. The TIGER study aims to improve early diagnosis by using a high-sensitivity, point-of-care Troponin I test already in the prehospital phase. The study is a randomized controlled trial, where participants are randomly assigned to one of two groups. One group receives standard emergency care along with the rapid Troponin I test in the ambulance. The other group receives standard care without the test. The goal is to evaluate whether the use of Troponin I testing leads to faster and more accurate identification of heart attacks, ultimately improving patient outcomes. In total, about 1,419 adult patients with chest pain or suspected heart attack will participate. The primary outcome being measured is the time from first medical contact to PCI (balloon angioplasty). Secondary outcomes include time spent in different parts of care, hospital length of stay, the occurrence of serious events (such as heart attack, stroke, or death), and the diagnostic accuracy of the test. The study has been approved by the Swedish Ethical Review Authority and includes safety monitoring through an interim analysis after the first 150 patients. Test results from the Troponin I analysis are clearly marked as part of the research study and should be interpreted by the responsible physician alongside other clinical findings.

Nebulized Fentanyl in Healthy Volunteers

Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study

Comparison of Three Pre-oxygenation Strategies

Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers. Study endpoints Primary Endpoint: Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. Secondary endpoints: * Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. * Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT) * Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5 * Time to reaching an Oxygen Reserve Index (ORi) =1 * Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions. Number of participants 15 participants per subgroup, i.e. 45 participants in total. Inclusion criteria * Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II * Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3 * Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day. After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow.

Nomogram for Predicting Difficult Laparoscopic Appendectomy

No prior studies have stratified the difficulty of laparoscopic appendectomy (LA). The investigators aimed to investigate preoperative factors as indicators of difficult LAs based on the experience of surgical trainees and to develop a predictive model accordingly.

Gender Differences and Age Related Differences in Emergency Department Admission

The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.

National Emergency Bariatric Surgery Audit

The goal of this observational study is to investigate the incidence, management, and outcomes of complications following bariatric surgery in patients in the United Kingdom. The main questions it aims to answer are: * What is the prevalence of unplanned interventions due to complications following bariatric surgery in the UK? * What are the current practices for managing these complications, and how do they impact patient outcomes? Participants will: Be identified from hospitals treating patients presenting with complications following bariatric surgery. Have their data collected regarding demographics, surgical history, complications, treatments, and outcomes. Researchers will compare different management strategies and their impact on patient outcomes, with the aim of identifying best practices to improve emergency bariatric care and factors leading to patients attending as an emergency.

How Can Volunteers in the NHS Be Best Supported?

This study aims to investigate the impact of volunteers in the English National Health Service (NHS) and increase the evidence base for supporting and developing volunteering to best help patients and services. The research will focus on one relatively established role: Community First Responders (CFR) supporting the ambulance service in English NHS Ambulance Trusts. We will take a mixed methods approach, combining qualitative and quantitative methods to learn more about the effectiveness and wider perceived value of the CFR role from the perspectives of CFRs themselves, other NHS staff and NHS patients who may interact with them. Our primary Research Question is: How can we maximise the impact of the Community First Responder role? Secondary Research Questions focus on what we can learn from the Community First Responders to support volunteer roles more widely. In particular: How can policy makers improve the deployment of volunteers? How do staff perceive the support they receive from volunteers (including impact on their workload and morale)? How do patients perceive the support they receive from volunteers? How are volunteers impacting services? What opportunities are there for further developing the volunteer role? We will work with (up to five) Ambulance Trusts already involved in the National Ambulance Volunteering Dashboard to extract quantitative data from existing management systems. These data will focus on (1) number and demographic characteristics of CFRs; (2) aggregate CFR activity (incidents attended, first on scene, responses times, response outcomes) and (3) CFR incident data (including location, time, category and CFR attendance). From these Trusts we will select 2 for qualitative data collection consisting of documentary analysis and semi-structured interviews with CFRs, NHS staff and patients. This research aims to generate evidence to inform decisions on where policymakers can most efficiently focus future volunteer interventions and how the NHS can best support volunteers in the system.

Expert Guided Training Versus Self Learning with Virtual Patients

Virtual patients have increasingly been used in the training of healthcare professionals to enhance critical decision-making skills in emergency patient management education. The aim of this study is to investigate the contribution of the virtual patient simulation used in the education of paramedic students by comparing the effectiveness of self-directed learning with expert-guided learning. Additionally, it is believed that the study will be beneficial for educators responsible for program design who are interested in integrating the case-based learning method with virtual patients into their curriculum.

Emergency Care Action Plans for Infants with Medical Complexity

An Emergency Care Action Plan (ECAP) is a tool intended to be helpful to providers when treating a child with complex medical needs during an emergency. Once created, ECAPs are added to the Electronic Health Record (EHR), shared with the child's caregiver(s), and kept up by all of those involved in a child's care. The goal of this study is to measure important health outcomes (ex. inpatient days, emergency department visits) in terms of the use of the ECAP for infants discharged from the Neonatal Intensive Care Unit (NICU). This study will also measure other real-time potential challenges related to the use of the ECAP including, but not limited to, if it is being used, if providers and caregivers want to use it, and if they keep using it over a long period of time.

Prehospital Management of Hypotensive Trauma in HEMS

Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality. Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes. Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies. With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome