Clinical Research Directory

Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient

Evaluate the performance for measuring inspiratory effort of non-invasive mandibular movement analysis compared to the reference technique oesophageal pressure (PES) variation, in ventilated and spontaneously breathing Intensive Care Unity (ICU) patients, during weaning from mechanical ventilation and within 48 hours after extubation. The investigators hypothesis is that the assessment of respiratory effort by MM analysis could represent a non-invasive and reliable alternative to the measurement of PES in critically ill patients.

Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients on Non Invasive Respiratory Support

Acute respiratory failure is a common, life-threatening condition where the lungs cannot provide enough oxygen to the body. Many patients are treated with non-invasive respiratory support (NRS) such as high-flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP). However, up to half of patients receiving NRS still deteriorate and require intubation and invasive ventilation, which is linked to longer hospital stays, more complications, and slower recovery. A major challenge in caring for these patients is that clinicians currently cannot directly see how well the breathing muscles (especially the diaphragm and parasternal intercostal muscles) and the lungs are working while the patient is using NRS. Existing bedside measures, such as respiratory rate or oxygen levels, only show part of the picture. They do not indicate how hard the patient is working to breathe or whether their respiratory muscles are becoming fatigued. This lack of information may delay important decisions about adjusting NRS settings or switching to other treatments. This study aims to find out whether two advanced but non-invasive, radiation-free bedside monitoring tools can be used effectively in routine care: 1. Ultrasound, which can measure breathing muscle thickness, movement, and lung aeration 2. Electrical impedance tomography (EIT), which uses a soft belt of small electrodes around the chest to measure changes in air and blood flow within different regions of the lungs in real time These tools have shown promise in earlier research, and interviews with patients and clinicians suggest they are comfortable, well-tolerated, and potentially useful. However, they have not yet been evaluated together in a real-world hospital environment where many acute respiratory failure patients are cared for outside the ICU. What the study will involve: Up to 100 adults with acute respiratory failure requiring any type of non invasive respiratory support will be recruited with the goal of obtaining complete data from at least 50 patients. Each participant will undergo ultrasound and EIT assessments up to seven times during the first 72 hours after starting NRS, plus an additional measurement if they improve enough to stop NRS or if they deteriorate and require intubation. These assessments take place at the bedside, require brief exposure of the upper chest, and last approximately 15-45 minutes. Routine clinical data-such as heart rate, oxygen levels, and breathing measures-will also be recorded. In parallel, clinical staff caring for these patients will complete a short Healthcare System Usability Scale questionnaire to rate how useful, understandable, and practical they find the information generated by ultrasound and EIT. Some staff may also take part in optional interviews to explore usability in more depth. What the study is trying to learn: The primary aim is to determine the usability of these monitoring methods meaning understanding if they are practical, easy to use, and helpful for clinicians making decisions about NRS treatment. Secondary aims include understanding: * how the respiratory muscles and lungs change over time during NRS * whether these changes are linked to treatment settings (e.g., flow rate, pressure support) * whether certain patterns are associated with treatment success or failure (intubation or death) * whether these tools could help identify patients at risk of deterioration earlier Risks and benefits: Both ultrasound and EIT are widely used, safe, and non-invasive. They involve no radiation, needles, or harmful exposure. Minor temporary discomfort from the gel or belt placement is possible. Participation will not change any clinical treatments. Although patients may not directly benefit, the study may help future patients by improving understanding of breathing muscle function and supporting more personalised respiratory care. By contributing to this research, patients and clinicians will help determine whether advanced monitoring can be realistically implemented in busy hospital settings and whether it could lay the groundwork for future trials aimed at improving outcomes for people with acute respiratory failure.

Lung Recruitment Assessed by 2D/3D-EIT and R/I Ratio in Acute Respiratory Failure Patients With Mechanical Ventilation

The purpose of this observational study is to assess the differences and consistency in evaluating lung recruitment potential between the recruitment-to-inflation ratio (R/I ratio) and three-dimensional electrical impedance tomography (3D-EIT) and two-dimensional EIT (2D-EIT) in mechanically ventilated patients with acute respiratory failure. The main questions it aims to answer is: Are the lung recruitment potentials predicted by 3D-EIT, 2D-EIT and the R/I ratio consistent? Participants will: Undergo a standardized PEEP titration protocol with synchronized EIT monitoring; Have R/I ratios measured at high and low PEEP levels.

Point-of-Care AI Assistance and Critical Care Outcomes: A Randomized Trial

This is a prospective, unmasked, randomized, multicenter clinical trial evaluating the impact of point-of-care large language model (LLM)-based decision support on diagnostic accuracy and clinical outcomes in adult medical intensive care unit (MICU) patients. Consecutive adult ICU admissions at participating community hospitals (initially MetroWest Medical Center and St. Vincent Hospital) will be screened for eligibility. Eligible patients will be randomized 1:1 to standard care or an AI-assisted group. In both arms, initial evaluation and management will follow usual practice. For patients randomized to AI assistance, de-identified admission data (history and physical, labs, imaging reports, and other relevant documentation) will be formatted and submitted to a state-of-the-art LLM (ChatGPT-5) at the time of admission. The AI-generated differential diagnosis and therapeutic recommendations will be provided to the admitting team for consideration. For the standard care arm, LLM output will be generated but not shared with clinicians. After discharge, a masked chart review will determine the "ground truth" primary diagnosis and extract outcomes including: Primary Outcome - a composite of medical errors (from time of ICU admission through day 7 of ICU stay, or ICU discharge, whichever comes first); Secondary Outcomes - 90-day mortality, ICU and hospital length of stay, and ventilator-free days.

Breathing Pattern Description in Pneumonia Patients

Surveillance and monitoring of patients with respiratory failure before or after undergoing mechanical ventilation is an underdeveloped area compared to the many possibilities of monitoring other non-invasive vital signs that we currently have. Severe respiratory failure usually affects oxygenation and ventilation. Continuous or frequent non-invasive monitoring of oxygenation is performed with pulse oximetry, with a margin of error between 1 and 4% of arterial oxygen saturation of hemoglobin. Ventilation cannot be fully monitored in non-intubated patients: Measurement of respiratory rate (RR) outside the Intensive Care Unit (ICU) is usually performed intermittently and manually by the nurse, often with a wide margin of error and, regarding tidal volume (VT), it cannot currently be monitored either directly or indirectly in non-intubated patients because the measurement itself interferes with respiration. Similarly, data on inspiratory and expiratory flows cannot be obtained, which are also altered in certain pathologies. The technique considered as a "gold standard" is spirometry, which requires the collaboration of the patient, and the interpretation of the results depends on the performance of the technique in a standardized way. Spirometry offers a single value; continuous monitoring is not feasible and due to the bias of the technique. More studies are needed to rule out the existence of different breathing patterns of acute respiratory failure and to identify outcome differences between them before recommending different support or treatment approaches. In a preliminary not published study conducted with healthy volunteers, a good correlation was observed between changes in temperature inside the Venturi mask using two TSC50 thermistors and breathing pattern recorded by thoracic and abdominal plethysmographic bands. HYPOTHESES: Monitoring respiratory activity, including both RR and the respiratory pattern (tidal volume, inspiratory flow, and the inspiration-to-expiration ratio), could enable early detection of respiratory patterns associated with the worsening of patients with COVID-19 pneumonia and severe pneumonia of other origins. OBJECTIVES Main Objective: To evaluate the ability of the respiratory pattern to early detect respiratory deterioration in patients hospitalized pneumonia before requiring mechanical ventilation. Specific Objectives: To describe the initial respiratory pattern and its evolution throughout the hospital stay of patients with acute respiratory failure caused by SARS-CoV-2. To describe the evolution of the respiratory pattern in patients with bacterial pneumonia admitted to the hospital who require supplemental oxygen.

Bed Side Assessment in Patients With Acute Respiratory Failure Under Invasive Mechanical Ventilation

The goal of this study is to learn about the respiratory mechanics in patients undergoing mechanical ventilation. The investigators can achieve this through the offline analysis of data provided by the ventilator. Within the field of respiratory mechanics, the study focuses particularly on the quantification of lung instability. What does lung instability mean? By this definition, the investigators refer to the part of lung tissue that opens during inspiration and then collapses during the subsequent expiration. The more diseased the lung (for example, in the case of viral pneumonia), the greater the quantity of this tissue. How is lung instability measured? In the context of the study analysis, lung instability is measured through the analysis of the low flow pressure-volume loop during ventilation. This graph illustrates how the volume of air in the lungs varies in response to the pressures applied by the ventilator during slow inflation and deflation phases. This maneuver is considered quick and safe and has been an integral part of our clinical practice for several years. Through this maneuver, investigators can examine the range of pressures provided by the ventilator during tidal ventilation. To assess lung instability, hysteresis is analyzed, which represents a distinctive characteristic of the pressure-volume loop. Greater hysteresis indicates a higher degree of lung instability. During the study, investigators will record not only hysteresis but also classical respiratory mechanics parameters (for example, elastance of the respiratory system, i.e., how stiff the lung is), parameters regarding gas exchange (blood oxygen and carbon dioxide levels), biometric data (for example, height and weight), and imaging (CT scans, lung ultrasound, and electrical impedance tomography) to relate them to the degree of lung instability.

The Effects of Different Non-invasive Respiratory Support

Patients with acute hypoxemic respiratory failure (AHRF) typically present with pathophysiological alterations characterized by the coexistence of respiratory dysfunction and hypoxemia. Respiratory dysfunction leads to dyspnea, increased work of breathing, use of accessory respiratory muscles, and hypercapnia, while gas exchange impairment results in hypoxemia. Studies have shown that hypercapnia, acidosis, and hypoxemia can all enhance inspiratory effort, which further increases negative intrathoracic pressure. In these patients, regional differences in airway resistance and lung compliance are often present, causing redistribution of air within the lungs. This redistribution manifests as gas movement from non-dependent to dependent regions, known as "pendelluft," which amplifies regional alveolar strain and ventilation heterogeneity. This phenomenon becomes more pronounced during noninvasive respiratory support when spontaneous breathing is preserved. Noninvasive respiratory support strategies mainly include high-flow nasal oxygen (HFNO), noninvasive positive pressure ventilation (NIV), and continuous positive airway pressure (CPAP). HFNO delivers high-flow gas through nasal cannulas, generating a certain level of positive end-expiratory pressure (PEEP) and flushing out anatomical dead space to improve gas exchange, thereby reducing inspiratory effort, lowering the work of breathing, and enhancing oxygenation. NIV, typically using pressure support ventilation (NIV-PSV), is a patient-triggered, pressure-targeted mode that provides inspiratory positive pressure above PEEP. By augmenting tidal volume and reducing inspiratory effort, NIV improves gas exchange; however, leaks may limit the effective delivery of PEEP, and full inspiratory synchronization can increase transpulmonary driving pressure and tidal volume. CPAP, by contrast, delivers a constant positive pressure during both inspiration and expiration. Compared with HFNO, CPAP generates higher PEEP, which facilitates alveolar recruitment and more effectively improves oxygenation. Relative to NIV, CPAP may reduce transpulmonary driving pressure and tidal volume. Different noninvasive respiratory support strategies exert varying effects on respiratory drive and regional lung strain, leading to differences in the occurrence and magnitude of pendelluft. Physiological studies have suggested that CPAP may offer greater benefits in improving oxygenation and reducing inspiratory effort; however, whether it can mitigate the occurrence and extent of pendelluft remains uncertain. Therefore, this study was conducted to visualize and quantitatively assess pendelluft in real time using electrical impedance tomography (EIT), aiming to verify whether CPAP has a superior effect in reducing pendelluft in patients with AHRF.

Advanced Respiratory Monitoring and Oxygen Therapy in Chronically Ill Patients With Acute Respiratory Failure

This study is testing whether a new type of home oxygen therapy, called high-flow nasal cannula (HFNC), can improve breathing comfort and quality of life for people with long-term lung or heart conditions who need oxygen after leaving the hospital. HFNC delivers warm, humidified oxygen at higher flow rates than standard oxygen therapy, which may reduce shortness of breath, improve sleep, and make daily activities easier. The therapy will be provided using the myAirvo™3 device, which also allows doctors to check patients' oxygen levels, heart rate, and symptoms remotely. All patients will also wear a small device (RootiREX) to monitor heart rhythm, sleep quality, and detect breathing pauses at night. Participants will try both treatments - HFNC and standard oxygen therapy - for short periods, in random order, so that researchers can directly compare the effects within the same patient. Each treatment period will last two weeks, with a short break in between. The main goal of the study is to see whether HFNC reduces shortness of breath (measured by the modified Medical Research Council scale). Other outcomes include comfort, sleep quality, quality of life, oxygen levels, and how well patients are able to use the devices at home. The study will last six weeks in total for each participant. Researchers expect that HFNC will improve breathing comfort, stabilize oxygen levels, and reduce the need for hospital visits during this time.

Cervical Erector Spinae Plane Block for Dyspnea in Acute Respiratory Failure: A Prospective Cohort

Dyspnea is common and distressing in patients with acute respiratory failure. In our intensive care unit, some patients receive a cervical erector spinae plane (ESP) block to help relieve dyspnea. This study will observe patients who receive bilateral cervical ESP blocks and measure changes in dyspnea using validated scales at predefined time points over 24 hours. We will also track vital signs, arterial blood gas values, and diaphragm movement on ultrasound.

Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which respiratory support is coordinated by the electrical activity of the diaphragm (EAdi). Aim of the study is to assess the physiological relationship between neural respiratory drive, as assessed by EAdi, and tidal volume, driving pressure, and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback or during acute respiratory failure. Additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.

Music Therapy During NIV Implantation in Pediatric Intensive Care Units

Non-invasive ventilation makes it possible to avoid intubation and improve patients' quality of life. However, pain is associated with discomfort and could lead to failure of this technique. The aim of this study is to measure the effectiveness of music therapy on pain levels during non-invasive ventilation in critically ill children. To this end, a pain score (Face Legs Activity Cry Consolability FLACC) will be assessed by raters blinded to the randomization arm during NIV initiation. The FLACC score will be compared before and during implementation of NIV between two groups: a control group (without music therapy) and an experimental group (with music therapy).