Clinical Research Directory

UP STUDY - Decipher Persistent Critical Illness Through in Deep Clinical Phenotyping.

Persistent Critical Illness (PCI) is a condition that affects some patients who remain in the Intensive Care Unit (ICU) for a long time, usually more than 10-14 days. It is estimated to occur in 5-20% of critically ill patients. A recent Portuguese study found that more than 14% of ICU patients stayed longer than 14 days. PCI is often associated with ongoing need for life support, such as mechanical ventilation or medications to maintain blood pressure. However, patients may also experience severe muscle weakness, repeated infections, or other complications, which makes this group very diverse. One of the main risk factors for prolonged ICU stay is sepsis, a severe infection that affects the whole body. Other factors-such as prior health conditions, use of corticosteroids, sedation practices, early versus late mobilization, fluid and antibiotic management, and delirium treatment-may also influence the development and course of PCI. This study aims to identify different clinical patterns ("clusters") among critically ill patients who remain in the ICU for more than 10 days. Patients will be followed until hospital discharge, and up to one year if data are available. Understanding these different patterns will help develop more personalized and effective care strategies for each patient profile. The study is a multicenter retrospective cohort including adult patients (≥18 years) admitted to participating ICUs for more than 5 days between 2021 and 2023. Data collected will include demographic, clinical, and laboratory information, details of organ support (such as mechanical ventilation or vasopressors), medications, nutrition, and rehabilitation practices. Statistical and machine learning methods will be used to identify groups of patients with similar clinical trajectories and to assess how these groups are related to outcomes such as survival, recovery of organ function, or long-term disability. Expected results are the identification of distinct clinical clusters of PCI that combine clinical and laboratory data, and the development of tailored management strategies to improve recovery and outcomes for patients with PCI.

NEURO - Prognostication Using Late Somatosensory Evoked - Potentials

The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.

Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing. Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.

Mechanical Insufflation-Exsufflation in Critically Ill Patients

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)

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.

Interprofessional Collaboration in the Cardiac Intensive Care Unit (CICU): An Action-Research Training Project

This study evaluates the impact of a structured interprofessional training program on daily collaboration within the Cardiac Intensive Care Unit (CICU/UTIC) at the University Hospital of Parma. In high-intensity clinical settings, rapid and accurate coordination between physicians, nurses, and healthcare assistants is vital. Ineffective teamwork often leads to communication breakdowns, potentially compromising patient safety and care quality. This project investigates whether an interactive, scenario-based educational program can strengthen role clarity, communication, and shared decision-making. The study seeks to determine if an active-learning program using interactive branching scenarios improves interprofessional collaboration more effectively than traditional methods. The researchers hypothesize that this simulation-based approach will significantly enhance professional outcomes, including self-efficacy, shared decision-making, and commitment to both the team and the profession. The study utilizes a convenience sample (approx. 5 physicians, 30 nurses, 8 healthcare assistants, and 10 students). Eligible participants include staff and students currently or recently active in the Parma CICU who provide informed consent. The intervention is delivered via a Moodle-based platform featuring case-based simulations. These scenarios replicate complex clinical pathways, such as: Cath-lab and Electrophysiology procedures. Heart failure management. TAVI (Transcatheter Aortic Valve Implantation) preparation. As participants navigate these scenarios, they must make critical decisions and receive immediate feedback designed to reinforce collaborative best practices. Data Collection and Timeline Data is gathered at three intervals: T0 (Baseline), T1 (Post-training), and T2 (6-month follow-up). Validated questionnaires measure: Attitudes toward physician-nurse collaboration. Perceived daily collaboration and decision-making satisfaction. Professional commitment and work-related self-efficacy. The training phase spans six months, with a subsequent six-month follow-up, totaling a 24-month project duration. Ethics and Privacy Risks are minimal, primarily involving the time required for participation. The primary benefit is the development of skills that foster safer, more coordinated patient care. Privacy is strictly maintained through pseudo-anonymization, with data access restricted to the research team.

Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial

The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation. The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.

Atrial Strain in Septic Shock

Septic shock is a critical condition associated with high mortality. Transthoracic echocardiography is widely used to evaluate cardiac function and guide treatment. Left and right atrial strain (LAS and RAS) measured via speckle tracking echocardiography have shown prognostic value in cardiovascular diseases. However, differences exist between echocardiographic software, leading to challenges in result comparability. This study aims to compare LAS and RAS measurements between ECHOPAC and UWS software, evaluate AutoStrain technology, and assess reproducibility across observers. The study is non-interventional and will use retrospective echocardiographic data from patients treated for septic shock. The findings will contribute to improving measurement standardization in critically ill patients.

A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.

Statseal® for Central Venous Catheter Insertion Sites in Critical Care

All participants in this clinical trial will be undergoing surgery and will have a central venous catheter (also known as a central line) placed in the large vein in the neck as part of their routine care. The purpose of this clinical trial is to compare different ways of dressing central lines. In current standard care, central lines are stitched in place and covered with a protective transparent dressing. This standard care will be compared with the addition of a haemostatic powder beneath the transparent dressing. This powder product aids clotting at the level of the skin, meaning that it prevents or reduces bleeding while helping to maintain a dry and protected environment. The main questions this clinical trial aims to answer are: * Will the addition of a haemostatic powder increase the durability of central line dressings? * What proportion of dressings required an unplanned change? * The reason(s) for any unplanned change * The incidence of bleeding around central line insertion sites * Were any skin problems observed once the dressings were removed? Once the dressings are applied, all central lines sites will be monitored as part of the participant's routine care. Participation in the clinical trial lasts as long as the first central line dressing remains in place. Central line dressings currently and routinely remain in place for up to, but not more than seven days. After this period, there will be no need for any research-related observations. Routine care will continue and will not be affected by the research. Participants will not be asked to make any extra visits over and above those needed for routine care.

Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria

The AZAVI study is a multicenter observational registry (ICU and Infectious Diseases departments), designed to evaluate the real-world use of aztreonam-avibactam for suspected or documented infections caused by metallo-β-lactamase (MBL)-producing Enterobacterales or highly resistant Gram-negative bacteria. The study combines a retrospective cohort (patients treated during the 12 months prior to the drug's hospital availability) and a prospective cohort (patients consecutively included over 24 months). The primary outcome is clinical success at day 7 after antibiotic discontinuation, defined as resolution of signs and symptoms of infection without recurrence or need for additional active therapy. Secondary outcomes include microbiological eradication, 14-day and 28-day all-cause mortality, infection relapse, length of stay, safety outcomes, and predictors of treatment failure. Data will be collected using a standardized CRF, including demographics, severity scores, infection site and pathogens, therapeutic regimens, organ failures and support, adverse events, and outcomes. Descriptive statistics and multivariable models will be used to assess real-world effectiveness, identify determinants of clinical response, and inform stewardship strategies. This registry will provide the first national-scale evidence on the role of aztreonam-avibactam in critically ill patients outside the framework of controlled clinical trials.

Effects of Artificial Intelligence Nurse Orientation Program on Psychological Outcomes and Length of Hospital Stay in Intensive Care Unit

Artificial intelligence (AI), now an integral part of healthcare services and presents numerous opportunities. Customized treatment plans, clinical decision support systems, predictive analysis for disease prevention, patient engagement and education, quality improvement, and error reduction are some of these opportunities. In the context of delirium prevention, risk assessment, and treatment planning, the AI-supported system AI-AntiDelirium is designed to standardize the approach to delirium management in alignment with the PADIS guidelines. A randomized controlled trial evaluating the effectiveness of this system found that the workload of nurses decreased, facilitated early diagnosis and prevention of delirium, and recommended evidence-based and individualized delirium interventions. A systematic review concluded that AI applications did not significantly impact the length of hospital stay and emphasized the need for further research. Also, AI platforms contributed to positive results in reducing anxiety and depression in patients. Furthermore, systematic reviews have demonstrated that AI-based chatbots are effective in alleviating symptoms of depression and anxiety. However, the literature includes a limited number of patient education programs specifically designed to prevent or manage delirium through AI-based approaches. Notably, there is a lack of studies comparing the effectiveness of AI-supported educational interventions with those delivered directly by nurses. The goal of this clinical trial is to develop a structured AINurse and Human Nurse orientation training program for intensive care unit (ICU) patients and compare the effects of these training programs on ICU patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. Hypotheses of the study: H1: Patients who receive the structured AINurse patient orientation training program will have longer delirium-free days than patients who receive Human Nurse orientation training. H2: Patients who receive the structured AINurse patient orientation training program will have lower levels of anxiety and depression than patients who receive the Human Nurse orientation training. H3: Patients who receive the structured AINurse patient orientation training program will have shorter lengths of stay in the intensive care unit than patients who receive the Human Nurse orientation training. Researchers will compare the AINurse patient orientation training program and the orientation training program provided by human nurses in terms of patients' delirium-free days, level of anxiety and depression, and length of stay in the ICU. * Those in the intervention group will receive the AINurse orientation training program twice daily for 3 days. * Participants in the control group will receive face-to-face structured orientation training from researchers twice daily for 3 days. * Delirium-free day assessment, anxiety and depression will be evaluated for patients in both groups over 3 days. * The length of stay in the intensive care unit will be monitored for patients in both groups.

Knowledge Levels and Experiences of Intensive Care Nurses on the Prevention of Pressure Sores: Mixed Method

This research aims to determine the knowledge levels and practices of intensive care nurses regarding the prevention of pressure sores. The main questions it aims to answer are: 1. What is the level of knowledge of intensive care nurses regarding the prevention of pressure sores? 2. What is the impact of sociodemographic characteristics of intensive care nurses on their knowledge level regarding the prevention of pressure sores? 3. What are the experiences of intensive care nurses regarding their practices for the prevention of pressure sores? In this research, a survey and interview technique will be applied to determine the knowledge levels and experiences of nurses working in adult intensive care units regarding the prevention of pressure sores and their practices.

Anesthesia and Critical Care Registry

In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care. This prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.

Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.

This international, multicenter, observational study aims to describe rehabilitation practices in Intensive Care Units (ICUs) worldwide. The primary objective is to provide an overview of current rehabilitation strategies used in ICUs globally. Secondary objectives include assessing the relationship between rehabilitation and key ICU outcomes such as ICU and hospital mortality, length of stay, duration of invasive ventilation, extubation failures, and long-term outcomes including quality of life and functional performance 28 days post-ICU discharge. The study will also compare rehabilitation practices across different geographic and economic regions to identify potential disparities. The study is structured into three modules, with participation contingent on local resources and feasibility. The BASIC Module (mandatory for all centers) gathers fundamental data on rehabilitation practices and their association with patient outcomes. The EXTENDED Module (optional) collects more detailed information on the type, timing, duration, and safety of rehabilitation interventions, including passive exercises, active mobilization, respiratory therapies, dysphagia training, occupational therapy, and cognitive support. The EXTENDED FOLLOW-UP Module (optional) evaluates the patient's quality of life and functional recovery 28 days after ICU discharge. By examining global rehabilitation practices and their impact on patient outcomes, this study aims to improve rehabilitation strategies in ICUs, contributing to better patient care, recovery, and long-term health outcomes.

Early Multimodal Therapy and Mechanical Ventilation

To assess the association between early multimodal therapy and the duration of invasive mechanical ventilation in the Intensive Care Unit at Fundación Santa Fe de Bogotá.

Focused Ultrasound Spleen Stimulation and Inflammation in Septic Shock

This study evaluates the safety and effectiveness of focused ultrasound spleen neuromodulation in patients with septic shock, a life-threatening condition characterized by excessive inflammation and organ dysfunction. The primary objective is to determine whether non-invasive, focused ultrasound stimulation of the spleen can reduce circulating inflammatory cytokine levels in this patient population. Eligibility Criteria: Adults aged 18 years or older Diagnosed with septic shock and admitted to the ICU within 24 hours Expected to require intensive care for at least 72 hours Study Protocol: Participants will be randomly assigned to one of two groups: Intervention Group: Will receive standard septic shock care plus twice-daily focused ultrasound stimulation over the spleen for five days, using a portable device. Control Group: Will receive standard septic shock care alone. Blood samples will be collected at baseline, Day 3, and Day 5 to measure inflammatory cytokine levels, including TNF-α, IL-1β, IL-6, and IL-10. Additional assessments will include lymphocyte subpopulations, organ function scores, ICU length of stay, 28-day mortality, and adverse events. Outcome Measures: Primary: Change in levels of inflammatory cytokines on Day 3 and Day 5. Secondary: Changes in organ function (SOFA score), ICU length of stay, 28-day survival, and safety/tolerability of the intervention.

Bed Bath With Auditory Hypnosis on ICU Patients

Intensive care units (ICUs) are specialized units where complex life-saving treatment and care activities are performed. Due to the treatment procedures performed in these specialized units, a large number of tools/equipment/devices/cables (endotracheal tubes, monitor cables, hemodialysis machines, mechanical ventilation, etc.) are placed on critically ill patients. These treatment devices restrict the movement of patients, creating obstacles to the independent performance of basic human needs such as personal hygiene. One of the individual hygiene practices frequently applied in ICUs is bed bathing. The application of bed bathing in ICUs varies according to institutional and clinical policies. In addition to its beneficial effects such as preventing infection, accelerating blood circulation, providing comfort and relaxation, etc., bed bathing also carries the risk of having a negative effect on physiological parameters. Eliminating or minimizing this risk is one of the primary care objectives of intensive care nurses. In this regard, it is crucial that bed baths, which are considered a routine nursing activity in ICUs, are performed in accordance with specific standards and protocols. In recent years, there has been an increase in the use of certain non-pharmacological care interventions in ICUs. One such intervention is auditory suggestion. Auditory suggestion refers to messages delivered through hearing to facilitate the adoption of specific thoughts, feelings, or behaviors. This method includes music, verbal suggestion, nature sounds, and other auditory stimuli that are believed to have the potential to influence the subconscious. In recent years, auditory suggestion has been integrated into the treatment processes of critically ill patients, particularly in intensive care units. This method is applied to reduce patients' stress, control pain, and support hemodynamic stability. Research has provided strong evidence supporting the physiological and psychological effects of auditory suggestion on both adult and pediatric patients. On the other hand, maintaining the patient's physiological parameters under control and increasing their comfort level while administering bed baths in the ICU are desired outcomes of nursing care. Based on this, the study was designed as a randomized controlled trial to investigate the effects of bed baths administered with auditory suggestion on physiological and comfort parameters in intensive care patients. The study, which will be conducted with a total of 66 ICU patients meeting the sample selection criteria, will apply the "bed bath protocol with auditory suggestion" to the study group and routine bed baths to the control group (only once). The study data will be collected using the "Patient Information Form" and the "Physiological and Comfort Parameters Monitoring Form" (data from the form will be collected and recorded before the bath, immediately after the bath, and 30 minutes after the bath). The study data will be analyzed using appropriate statistical methods.

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments

The aim of this study was to investigate the effects of different oxygen therapy modalities (including nasal cannula oxygen, mask oxygen and high-flow nasal cannula oxygen) on the correlation between Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of nasal pressure and esophageal pressure and their underlying mechanisms under different conditions of oxygen therapy, to analyse the effects of oxygen therapy parameters on the relationship between the two, and to explore the feasibility of nasal pressure as a non-invasive monitoring indicator, in order to replaceor supplement esophageal manometry in clinical practice, especially in patients with respiratory distress and instability.Meanwhile, this study will also evaluate the effects of different oxygen therapy modalities on patients' respiratory mechanics and comfort, provide a scientific basis for the clinical selection of individualised oxygen therapy regimens, and ultimately provide new physiological evidence for the management of oxygen therapy in patients with acute respiratory failure in the intensive care unit (ICU) and outside the ICU, promote the development of non-invasive monitoring technology, and improve the clinical prognosis and therapeutic experience of patients.

Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials

Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.

Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients

The goal of this observational study is to learn about the association between vasopressor exposure levels and outcomes in adults with cardiogenic shock receiving VA-ECMO. The main question it aims to answer is: Does reduced exposure to vasopressors lower the 30-day mortality in patients with cardiogenic shock when receiving ECMO support? Participants who are receiving ECMO support for cardiogenic shock as part of their regular medical care will have their data collected, including information about their vasopressor use and mortality outcomes, over the course of the study.

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.

Measuring Family Engagement in Care (The FAME Study)

There are currently no validated tools to specifically measure family engagement in the intensive care unit (ICU). To address this gap, an interdisciplinary team developed a novel instrument to measure family engagement in the ICU. This will be a prospective observational cohort with an embedded qualitative study to validate the FAMily Engagement (FAME) instrument in the ICU setting. This study will also evaluate the association between family activation, engagement, and family-centred outcomes, and exploring factors (age, relationship, sex, gender, race/ethnicity) that may influence family engagement in the ICU.

Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients

High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.