Clinical Research Directory

Functional Incremental Stepping in Place Test (F-IST) Validation

The purpose of this multi-site prospective study is to assess validity of a new step test called Functional-Incremental Stepping-in-place- Test (F-IST) compared to gold-standard cardiopulmonary exercise testing (CPET) and to physical function and health perception, respectively. The investigators will also assess test-retest reliability of the F-IST. The investigators hypothesize that the F-IST will have high validity and test-retest reliability to be used in field testing environments such as the ICU.

Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors

Invasive pulmonary aspergillosis (IPA) is a life-threatening fungal infection of the respiratory system, caused by a specific fungus called Aspergillus species. It is already known that patients with a weakened immune system are at higher risk of developing this disease. Recently, it has also been shown that patients with viral pneumonia (such as influenza or COVID-19) and patients with liver cirrhosis who are admitted to the intensive care unit are also vulnerable to this infection. This study aims to better define the epidemiology, clinical risk factors, outcomes, and treatment of IPA in ACLF patients admitted to the ICU. By combining clinical data with histological findings from autopsies, the study seeks to improve diagnostic accuracy, risk prediction, and timely initiation of antifungal therapy.

PRophylaxis Against Early VENTilator-associated Infections in Acute Brain Injury

This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury. An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest. Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia. The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving. When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.

End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Palliative Care Protocol in the Intensive Care Setting

The ARREVE-3 trial will evaluate whether a structured palliative care protocol can improve end-of-life management for mechanically ventilated ICU patients in whom a decision to withdraw life-sustaining therapies has been made. This cluster-randomized controlled trial compares protocol-based care with usual practice across participating centers. The intervention includes comprehensive guidance on symptom management, sedation, nursing care, withdrawal procedures, and family support, supported by standardized staff training. The primary endpoint is adherence to recommended end-of-life practices, while secondary outcomes assess patient comfort, communication with relatives, and the impact on families and healthcare professionals

Factor Associated With Mortality in the ICU

ICU mortality indicates the severity of disease, healthcare quality, and the efficacy of interventions. The severity scores are tools to predict the risk of mortality in the ICU, and the APACHE II score is frequently used for this purpose. However, studies validating the score in Colombia are limited. There is uncertainty about the precision and discrimination capacity of the APACHE II score in a population that varies from the original, with varying diseases, and in a different timeline. The investigators determined to evaluate: 1. Evaluate the rate of mortality in the ICU by type of disease and type of admission. 2. The factors associated with mortality. 3. Validate the performance of the APACHE II score as a predictor of mortality.

Intelligent Lung Support in the Intensive Care Unit

The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers. The main question of the study: How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?

Non-inferiority of Nurse-performed Versus Interventional Cardiologist-Performed Radial Catheterization in Elective Coronary Angiography: a Single-center, Open-label Randomized Trial.

Coronary angiography (or coronary arteriography) is a heart examination performed with contrast media to detect and treat coronary stenosis. The procedure involves the insertion of a catheter (a thin flexible tube) into a blood vessel in the groin (femoral) or arm (radial), which is then guided to the heart (cardiac catheterization). In some healthcare institutions, this medical procedure may be performed by a specially trained registered nurse (RN) under the supervision of an interventional cardiologist. Radial vascular access generally carries a low risk. However, complications such as hematoma, arterial dissection, or secondary occlusion may occur at the puncture site. Fluoroscopy is associated with a certain degree of radiation exposure. By acquiring skills traditionally within the scope of medical practice, Article 119 of Law No. 2016-41 of January 26, 2016, on the modernization of the healthcare system, created Article L. 4301-1 of the French Public Health Code, introducing the principle of advanced practice for allied health professionals. Since its implementation in July 2018, advanced practice has aimed to achieve two objectives: improving access to care and enhancing patient care pathways, while reducing physicians' workload in targeted conditions. A local cooperation protocol was submitted to the Regional Health Agency (ARS) on December 14, 2022. Since catheterization is considered a medical act, the submission of such a protocol is mandatory. This raises the question: Can radial catheterization, as a medical procedure, fall within the scope of advanced nursing practice under the supervision of an interventional cardiologist? A literature review on nurse-performed cardiac catheterization identified only one publication, in the journal HEART (1997). In this study, nurses from a cardiology department in Oxford, UK, performed the entire coronary angiography procedure. The study demonstrated that a specialized nurse with appropriate baseline experience could be trained to safely perform standard transfemoral cardiac catheterization procedures (including coronary angiography) in low-risk cases. There was no significant difference in performance (complication rates) between the nurse and cardiologists using the same angiographic facility. The risk of complication in catheterization and angioplasty is estimated at 1 in 1,000 in the literature. The above-mentioned study is the only one addressing our research question and showed no significant difference in complications between nurses and cardiologists. However, the benefit of radial access performed by nursing staff has not been established. Thus, the benefit-risk ratio for participants in our study remains unknown, though the risk is expected to be low, particularly as the procedure performed by the nurse is carried out under medical supervision. Furthermore, patients will be monitored for at least 8 hours post-procedure, with extended observation depending on clinical evaluation by the treating physician during hospitalization after randomization. Following discharge, patients will be reassessed at 3 months to collect outcome data and follow-up parameters. Nurses in the cardiology/ICU department are specially trained, with validation of several competencies. Only RNs who have acquired and validated the following eight competencies participate in the CATHE protocol: Competency 1: Knowledge of cardiology-specific diseases and care. Competency 2: Management of patients undergoing coronary angiography. Competency 3: Preparation of the coronary angiography suite. Competency 4 (part 1/2): Acquisition of knowledge and procedures specific to coronary angiography. Competency 4 (part 2/2): Acquisition of knowledge and procedures specific to cardiac catheterization activity. Competency 5: Assistance to the operator during the procedure. Competency 6: Management of adverse events occurring during the procedure. Competency 7: Development of professional behavior and skills related to coronary angiography. Competency 8: Performance of peripheral radial catheter insertion in the coronary angiography suite (within the framework of the local cooperation protocol and the CATHE study). Each competency is assessed and validated prior to participation. The primary objective of our study is to demonstrate that in France, an experienced and specially trained registered nurse can safely perform radial catheter insertion under the supervision of an interventional cardiologist. This does not involve femoral catheterization, nor nurse-performed coronary angiography as described in the earlier publication. The study is strictly limited to radial arterial catheterization.

VoiceLove: An App-Based COMMunication Tool Designed to Address DeliriUm and Improve Family ENgagement and PatIent/Family SatisfaCtion in CriticAlly Ill PaTiEnts (COMMUNICATE)

VoiceLove is a phone application allowing family and patients to share information in a secure platform. This project will compare the VoiceLove app to usual care to learn about whether VoiceLove improves patient-family communication, family engagement, and ICU delirium.

Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study

Ten years after our team's publication, practices have changed considerably in the management of severe cirrhotic patients. This study will analyse these practices in primary care hospitals and in a tertiary centre, and assess the impact of these changes on the prognosis of these patients. The following hypotheses will be tested: * Improvement in intensive care and overall prognosis compared with data from the literature prior to 2014 * Improved access to liver transplantation compared with the literature prior to 2014 * Improvement in intensive care unit practices (for example: application of recommendations published by learned societies concerning the intensive care unit management of patients with cirrhosis, access to comfort care, degree of clinical severity on admission to the intensive care unit, etc.). * Centre' effect: variability in the phenotype of patients admitted to intensive care depending on the technical facilities available and whether or not the hospital centre has access to TH.

Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol

Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given. A sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications. However, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients. Aims: * To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients. * To develop a sedation protocol for ECMO patients with input from patients, their family, and staff. Design/methods: Study 1: The investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2. Study 2: The investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group. Patient and public involvement/engagement: The investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public. Impact/dissemination: The investigators will share findings through social media, patient charities, research papers and conferences.

Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface

Pressure injury (PI) is characterized as damage to the skin and/or underlying tissues resulting from sustained pressure or a combination of pressure and shear forces between the patient and the support surface. Prolonged pressure is a well-established risk factor in the development of PIs. Frequent repositioning and routine patient care have been recognized for decades as integral components of PI prevention and treatment protocols. The duration of interface pressure is as critical as its magnitude. When interface pressure exceeds the mean capillary blood pressure, blood flow can be compromised, leading to ischemia in affected areas, which may progress to necrosis if sustained over time. Furthermore, it is widely accepted in the literature that tissue becomes at risk when interface pressure exceeds 30 to 32 mmHg. In this context, continuous lateral rotation therapy (CLRT) offers a potential alternative for managing critically ill patients. CLRT involves continuous mechanical rotation of the patient in the lateral plane. However, its effects on skin integrity remain poorly understood. Despite the rationale behind and widespread recommendation of repositioning, the lack of robust evaluations on how repositioning impacts interface pressure creates uncertainty, underscoring the need for high-quality trials to assess different strategies for implementation. Although lateralization is a pragmatic strategy for preventing pressure injuries, its use in critically ill patients requires an integrated assessment of respiratory, hemodynamic, and gastroesophageal effects. Therefore, this study proposes an innovative approach by evaluating, for the first time, the effectiveness of automated postural change with simultaneous monitoring of tissue integrity, pulmonary function, cardiovascular stability, and gastroesophageal protection. The aim is to optimize pressure injury prevention, improve pulmonary mechanics, ensure hemodynamic stability, and preserve gastroesophageal safety in critically ill patients.

A Trial of Staff Time With Proned Patients in the ICU Using the 'BathMat'

Proning is a way of helping people who are very sick and have trouble breathing. It involves lying patients on their front to get more oxygen into their body. This process happens in a part of the hospital called the Intensive Care Unit, and can last up to 16 hours per day. When in this position, doctors need to turn the patients' head and move their arms every 2-4 hours. Doctors call this repositioning. It helps prevent sores as well as other injuries. To do this, the health care team slide the patient up the bed, so that their (supported) head hangs over the end of the mattress. The head is then turned before the patient is slid back down the bed; their arms are then moved into a different position. This is currently performed by a team of 5+ staff and takes lots of time and resources. The process is also potentially dangerous because it requires a lot of movement which can hurt patients or staff. To make repositioning easier and safer, a group of doctors and engineers have created a new device. It is like a cushion that goes under the patient and inflates. This allows staff to reposition patients without needing to slide the patient on the bed. This also reduces the number of staff needed and lowers the risk to patients and staff. Feedback from staff, patients and the public are being used to help improve the system. To see if the new device works well in other hospitals, the investigators are planning to do a study with 30 patients in up to 4 different hospitals. This will last 14 months, and they will collect information on how well it performs. They will ask patients if they want to take part and will collect feedback after they leave hospital. During the study, staff from each hospital will monitor the device to make sure it is safe and record how useful it is. Any problems will be recorded, and staff will be asked for their opinions on how it affects their work. As well as monitoring safety, they will record the time saving achieved. This is important as it allows repositioning more often, which may reduce pressure sores. It also allows staff to spend more time focusing on other patients and important tasks. To share the results with other doctors, the researchers will write reports and give presentations. If successful, they will start making and selling the device to help sick patients on Intensive Care.

RECOMMEND Platform Trial

The goal of this platform trial is to determine the efficacy, safety and cost-effectiveness of various interventions in patients with acute cardiorespiratory failure requiring extracorporeal membrane oxygenation (ECMO) The main question the platform trial aims to address is to determine the effect of a range of interventions on survival, organ support and resource utilisation to day 28 for hospitalised patients receiving ECMO. Researchers will compare various interventions within multiple platform trial domains to see if the interventions have effects on survival, organ support and resource utilisation for the patient cohort. Participants will be enrolled in accordance with the platform trial's domain structure to answer the research questions.

Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis

Venous thromboembolism (VTE) is frequent in patients in the intensive care unit (ICU). Pharmacologic prophylaxis is sometimes contraindicated, and mechanical prophylaxis is used. The primary objective of the study is to compare Pulsed Electromagnetic Field Therapy (PEMF) with conventional mechanical prophylaxis for the prevention of VTE in patients in the ICU.

To Evaluate Transport Safety Between Different Scanning Methods for Patients in the Intensive Care Unit (ICU)

The goal of this study is to assess how safe it is for critically ill patients in the Intensive Care Unit (ICU) to undergo a PET scan. A PET scan is a type of medical imaging used to help determine why a patient is sick. It is similar to a CT scan but involves a small amount of radioactivity to highlight areas of concern in the body. For a PET scan, patients need to be transported from the ICU to the scanning room, which can be risky because ICU patients are often very fragile. After a patient gets the PET scan injection, their body gives off a small amount of radiation for a short time. Because of this, doctors and nurses have to keep some distance to protect themselves. This means they keep an eye out for the patient from a bit further away than normal. This makes the procedure slightly riskier, especially for very sick patients. This study aims to answer the question: Is getting a PET scan riskier for ICU patients than a regular CT scan? All patients in this study will continue to receive their usual critical care. Researchers will closely monitor the scanning process to evaluate its safety. PET scans are already widely used to detect cancer, but new advancements may allow us to use them more often to diagnose infections. Before this can become routine practice, we need to ensure that PET scanning is just as safe as other commonly used imaging techniques. This study will assess all ICU patients undergoing a PET scan-regardless of the reason for the scan-to determine how safe the procedure is in critically ill individuals.

Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics

Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects. However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics. The Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?

Evaluating the Use of Artificial Intelligence to Improve Family Conversations for Intensive Care Patients and Their Families

This study looks at how artificial intelligence (AI), like generative pre-trained transformer (GPT-4), can help doctors in the intensive care unit (ICU) save time and improve communication with families. Right now, doctors spend a lot of time writing notes after family conversations, which takes time away from patient care. The investigators are testing whether AI can create accurate and easy-to-understand summaries of these conversations, making it quicker for doctors to document and clearer for families to understand. ICU doctors and adult family members of patients will take part in this study, with their full consent. The goal is to see if this new technology can make life easier for doctors while helping families better understand medical information.