Clinical Research Directory

A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure

This prospective, open-label randomized controlled pilot trial will enroll participants at the Yale New Haven Hospital. Patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (IMV) and are admitted to either the cardiac intensive care unit (CICU) or medical ICU (MICU) will be included. Subjects meeting eligibility criteria will be randomized 1:1 to one of the two treatment groups: * Intervention: Extubation to high-flow nasal cannula (HFNC) * Control: Extubation to non-invasive ventilation (NIV)

Heart Rate VAriability as a MaRker for tItrATing hIgh flOw Nasal Cannula Therapy

High-flow nasal cannula is a type of non-invasive respiratory support that helps patients breathe more comfortably. Because the flow is high, it can deliver more oxygen to the lungs and make breathing easier by reducing the effort needed to breathe. However, the best strategy to determine the best oxygen flow rate remains uncertain. Reducing flow rates prematurely can increase work of breathing and prolong ICU stay, while unnecessary prolongation can increase costs. Currently, evidence to guide titration is limited. Heart rate variability is the natural variation in the time between each heartbeat. Heart rate variability reflects the level of autonomic nervous system activity in response to stress. The autonomic nervous system is the part of the nervous system that automatically controls how heart rate speeds up and slows down. When heart rate variability is higher, it indicates that the system is able to adjust to changes in the body, including stress. However, when heart rate variability is low, it indicates that the system is constrained and in a state of stress. The VARIATION study is designed to characterize how heart rate variability goal of this observational study is to learn whether heart rate variability can serve as a marker of the appropriateness of high flow nasal cannula flow support during flow titration in patients with respiratory failure. The main question it aims to answer is: Does heart rate variability change before other conventional respiratory signs when there are changes in respiratory function due to inadequate flow rate? Participants already on high flow nasal cannula as part of their regular medical care will: 1. Undergo a stepwise decrease in high flow nasal cannula flow rate. 2. Be recorded continuously with electrocardiogram and electrical impedance tomography.

Intubation Checklist in the Intensive Care Unit

This retrospective study aims to explore whether the introduction of a preprocedural checklist for intubation in the intensive care unit (ICU) is associated with a lower incidence of intubation-related complications. Using a database where protocols from intubations in the ICU before implementing a checklist and after we will investigate whether a checklist affects early desaturation and hypotension after intubation.

Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.

Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. By decreasing the amount of time patients spend on the ventilator, they are less likely to develop complications such as infections, weakness or more procedures.

Evaluation and Optimization of Telephone Triage Using Artificial Intelligence (AI) Models for the Detection of Demands for Time-dependent Pathology at the Emergency and Urgent Care Coordination Center (CCUE).

Improving Telephone Triage in Emergency Calls with AI The Coordinating Centre for Urgencies and Emergencies in Andalusia (CCUE) handles thousands of calls every day. Each call needs to be assessed based on the information given over the phone to determine how serious the case is. The reasons for calling range from minor health issues to life-threatening emergencies like cardiac arrest (CPA). This project focuses on improving telephone triage for four key emergency situations that often indicate severe or life-threatening conditions: Unconsciousness / Cardiac arrest Difficulty breathing Chest pain (non-traumatic, possible heart-related issues) Stroke symptoms Our goal is to make telephone triage more accurate and efficient by using advanced Artificial Intelligence (AI) techniques, including Machine Learning (ML) and Natural Language Processing (NLP). These tools will help CCUE operators make better and faster decisions, ensuring that patients receive the right care as quickly as possible. How it will be done: The investigators will analyze anonymized historical call data from the emergency coordination system (CCR) and digital clinical records (HCDM). This includes: Structured data: Predefined fields, such as answers to standard triage questions. Unstructured data: Free-text notes and other information recorded during the call. A hybrid AI approach will be used, combining: Traditional AI methods (supervised learning and deep learning) to classify cases. Generative AI techniques (advanced language models) to extract useful insights from free-text data. Building the Best Prediction Model To find the most effective AI model, we will test different machine learning techniques, including: Decision Trees Random Forests Support Vector Machines (SVM) XGBoost Ensemble methods Neural Networks We will also analyze which questions and variables are the most important in predicting the severity of a case. Based on this, we will suggest improvements to the current triage questions to enhance accuracy. Measuring Success We will evaluate the AI model using key performance metrics, including: Accuracy (overall correctness) Sensitivity (ability to detect real emergencies) Specificity (ability to avoid false alarms) False Positive \& False Negative Rates (how often the system makes mistakes) Likelihood Ratios (how well the system distinguishes between urgent and non-urgent cases) F1-Score \& ROC Curve (overall performance indicators) Why This Matters This project will assess how effective the current telephone triage system is and develop a new AI-powered model to improve it. The goal is to help emergency operators quickly identify the most serious cases, reducing response times and improving patient outcomes. In the future, the investigators aim to integrate this improved AI model into the CCUE system to enhance emergency response across Andalusia.

Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients

A multimodal educational intervention to target an oxygen saturation target range (SpO2 90-96%) will reduce ventilator length of stay and reduce occult hypoxemia by increased awareness and adherence to a designated oxygen saturation target range.

Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure

Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.

Mode of Ventilation During Critical Illness at Multiple Centers

The goal of this clinical trial is to learn whether the choice of ventilator mode for patients on breathing machines in the intensive care unit affects their survival and recovery. To do this, researchers will assign the entire participating intensive care unit to one of the three available ventilator modes, alternating which mode is assigned in random sequence every 2 months. The main question it aims to answer is: Does the choice between volume control, pressure control, and adaptive pressure control affect the number of days that patients are alive and free of the breathing machine?

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

Liberation from mechanical ventilation involves three steps: weaning, readiness assessment, and extubation. Readiness is determined using clinical criteria such as improvement of the underlying condition, hemodynamic stability, and adequate respiratory effort. Successful extubation is defined as not requiring invasive support within 48 hours. Due to the complexity of ICU patients, various clinical parameters and multi-component scores have been developed to predict extubation success. This study aims to develop and evaluate a multi-component score, the Readiness for EXtubation score (REXs), to predict extubation readiness in ICU patients under invasive mechanical ventilation.

EIT-Guided Respiratory Physiotherapy for Prolonged Mechanical Ventilation (PMV)

Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Electrical impedance tomography (EIT) provides real-time bedside visualization of regional ventilation and enables individualized respiratory physiotherapy strategies. This multicenter randomized controlled trial aims to evaluate whether EIT-guided respiratory physiotherapy improves ventilator-free days at day 28 compared with conventional respiratory physiotherapy in adult patients with PMV. Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time EIT imaging is used to individualize physiotherapy strategies based on predefined ventilation distribution indicators, while the control group receives standardized physiotherapy according to institutional protocols without EIT guidance. Secondary outcomes include successful liberation from mechanical ventilation, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale, healthcare resource utilization, and safety outcomes.

Acute Respiratory Failure and COVID-19 in Real Life

In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe. No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19). The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.

Effects of PBMT-sMF in Mechanically Ventilated Patients

The goal of this clinical trial is to evaluate the effectiveness of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in adult patients who require mechanical ventilation. The main questions it aims to answer are: (i) Does PBMT-sMF lower the length of stay in the intensive care unit (ICU) for mechanically ventilated patients? (ii) Does PBMT-sMF increase the diaphragm thickness in mechanically ventilated patients in the ICU? Researches will compare active PBMT-sMF plus standard of care to a placebo PBMT-sMF plus standard of care to see if active PBMT-sMF works to prevent or retard disuse atrophy of the diaphragm during mechanical ventilation.

Bedside Lung Ultrasound to Monitor Lung Recruitment in Obese Patients

Patients with morbid obesity who require a breathing machine (mechanical ventilator) in the Intensive Care Unit (ICU) frequently experience partial lung collapse. This happens because the extra weight of the chest and abdomen presses on the lungs, reducing their capacity and making it difficult to maintain adequate oxygen levels. To address this, doctors often perform a standard lung recruitment maneuver, which involves temporarily increasing the air pressure from the ventilator to gently pop open the collapsed lung areas. However, standard bedside monitoring tools make it difficult to see exactly how well the different regions of the lungs are reopening. This prospective observational study aims to evaluate the use of Bedside Lung Ultrasound (LUS), which is a safe, radiation-free imaging tool, to monitor how well the lungs respond to these maneuvers in real-time. During the study, researchers will use a standardized 12-zone ultrasound scan to examine the lungs of mechanically ventilated adult patients (BMI ≥ 33 kg/m²) before, during, and after a step-by-step lung recruitment maneuver. By calculating a "Total Lung Ultrasound Score," the medical team can directly visualize and measure the transition from collapsed tissue to normal, aerated lung tissue. Furthermore, the ultrasound will be used during a step-down pressure phase to help identify the patient's "optimal PEEP" (Positive End-Expiratory Pressure), which is the exact customized pressure needed to keep the lungs open after the maneuver is complete, thereby improving oxygenation and minimizing the risk of lung injury.

Supraglottic Airway for Resuscitation in Preemies

The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0/7 and 33 6/7 weeks' gestation who require PPV at birth. The main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0/7 to 33 6/7 weeks' gestation premature infants? Participants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.

Double Triggering Asynchrony in Mechanically Ventilated Patients.

This observational study examined double triggering asynchrony in28ICU patients on mechanical ventilation. Researchers collected data on patient characteristics, health conditions, and outcomes to understand how this problem affects critically ill patients. Findings may help improve ventilator care in intensive care units.

Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

This protocol describes a randomized controlled feasibility vanguard study designed to investigate the implementation and effects of esophageal pressure-guided positive end-expiratory pressure (PEEP) titration in patients with high body mass index (BMI) mechanically ventilated patients at the Edmonton Zone. The study will enroll 30 patients with body mass index (BMI) \>=30 kg/m2 who require invasive mechanical ventilation, randomizing them in a 1:1 ratio to receive either esophageal pressure-guided PEEP titration or standard care management. The primary objective focuses on establishing the feasibility of conducting a larger definitive trial, while secondary objectives examine differences in applied PEEP levels, respiratory mechanics, and clinical outcomes between groups. The intervention protocol targets end-expiratory transpulmonary pressure of 0-2 cmH2O.

Low and High Flow Suctioning in Intubated Infants

Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.

Noninvasive Technique and High Flow Nasal Oxygen in Respiratory Failure

After obtaining Institutional Ethical Committee approval of Faculty of Medicine, Minia University and written informed consent from patients or first- degree relatives, this prospective randomized non-blind comparative study will be conducted in adult intensive care unit (ICU) of Anesthesia, Intensive Care and Pain management department Minia university hospital over a period from September 2025 to April 2026. This study is designed to compare the effectiveness of two protocols of sequential use of High Flow Nasal Cannula (HFNC) and noninvasive ventilation (NIV) versus NIV alone in patients with Acute Respiratory failure (ARF) admitted to the intensive care unit (ICU). The study will include 75 patients of both sexes, classified as ASA class Ⅰ-ⅠⅠⅠ, divided into three groups with 25 patients in each group.

Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.

Ventilator associated events (VAE) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the ICU. VAE have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. Operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. ICU teams are encouraged to follow best practice protocols to help liberate and prevent VAEs. Yet, compliance with protocols in most ICUs is suboptimal for multiple reasons. With the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (BMDI) such as Capsule (UTMB's BMDI system), software systems have been developed to help identify variances in the standard of care. Automation in near real-time ventilator data feedback has been shown to reduce the incidences of VAEs. This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated events (VAE), alarm policy compliance, ventilator weaning, and lung protective analytics. Goals: 1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis. 2. Provide the RKP tool to the ICU team to determine if the use of RKP's webportal and Messenger Zebra phone app improves quality of mechanical ventilation and outcomes. 3. To determine a return on investment (ROI) for a software system like RKP.

Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study

Study Objective This prospective observational study aims to investigate the role of the Diaphragmatic Physiology Similarity Index (DPSI) derived from speckle tracking ultrasound in titrating high-flow nasal cannula (HFNC) flow settings, and to evaluate its application in patients with acute respiratory failure. Primary Research Questions To characterize the features of the DPSI in healthy individuals and in patients with acute respiratory failure. To assess the behavior of the DPSI under different HFNC flow settings in patients with acute respiratory failure. Secondary Research Questions Feasibility and inter-operator reproducibility of diaphragmatic speckle tracking. Assessment of the Diaphragmatic Contraction Synchrony Index. Evaluation of End-Diaphragmatic Residual Contraction (EDRC). Additional fundamental parameters, including diaphragmatic displacement velocity and maximum displacement.

Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.

Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with different ventilators, in people receiving NIV therapy for respiratory distress or respiratory insufficiency. The main question(s) it aims to answer are: * Does the new mask reduce breathing rate compared with a standard NIV mask? * Does the ventilator perform as expected when used with the new mask, including pressure delivery and leak? * Do clinicians and participants find the new mask fits and functions well? Three iterations of the new mask (vented, non-vented, dual limb) will be compared to standard of care to see if the mask reduces the need to breathe and performs consistently across ventilators compared with usual NIV masks. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ What Participants Will Do Participants will wear two different NIV masks, each for one hour, during a single study session lasting approximately 2.5 hours. Participants will be asked to: * Wear a small, stick on carbon dioxide (CO₂) sensor on the skin. * Use their usual NIV mask for one hour while ventilator data are collected. * Switch to the investigational mask for one hour while ventilator data are collected. * Choose whether to return to their original mask or remain on the investigational mask after the study period. * Caregiver opinion on the mask will be collected. Participants may also choose (optional): * To have three small blood samples taken (These samples are optional, and participants can still take part in the study if they decline them.) * One when they agree to take part in the study * One when the investigational mask is fitted * One after wearing the investigational mask for one hour * To provide feedback on how the two masks felt and performed. During the study, researchers will collect data from the ventilator, including: * Breathing rate and depth * NIV pressure settings * Amount of air leak Research staff will also complete a short form assessing how well the mask fit and functioned. Participants will remain in the study until the investigational mask is removed.

Impact of PEEP on Respiratory Effort During Assisted Ventilation

Assisted mechanical ventilation is widely used to preserve diaphragmatic activity and improve lung aeration in patients with acute respiratory failure. However, during assisted ventilation, excessive inspiratory effort may develop and contribute to lung injury, diaphragmatic overload, and patient self-inflicted lung injury. Optimizing ventilator settings to modulate respiratory effort therefore represents a major physiological and clinical challenge. Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment and respiratory system mechanics and may influence inspiratory effort by modifying lung volume, compliance, and respiratory drive. Despite its widespread use, PEEP titration in clinical practice is still mainly guided by oxygenation parameters, while its direct effects on inspiratory effort during assisted mechanical ventilation remain insufficiently characterized. This physiological randomized crossover study aims to evaluate the effect of four predefined levels of positive end-expiratory pressure (0, 5, 10, and 15 cmH₂O) on the respiratory system and inspiratory effort in adult patients receiving assisted mechanical ventilation. Patients will be exposed to each PEEP level in randomized order, with stabilization and washout periods between conditions, while ventilatory support settings other than PEEP are kept constant.

Critical Care Admission Following Emergency Department's Resuscitation Room Care

This prospective multicenter observational study aims to describe resuscitation room activity in France and to compare critical care admission within 24 hours between patients directly admitted to the resuscitation room and those admitted secondarily after initial emergency department management. Adult patients admitted to the resuscitation room over a 72-hour period in participating centers will be included. Data collection includes patient characteristics, triage severity, physiological parameters, critical interventions, and outcomes at 24 hours.