Clinical Research Directory

Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit

This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and respiratory rate measured by a pulse oximeter. Adults with acute respiratory failure admitted to the Respiratory Intermediate Care Unit (RICU) of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) receive oxygen titrated automatically by EMILY.AI and, in the same monitoring session, oxygen titrated manually by the nursing team while the device records saturation and flow. The study measures how much of the time patients stay within their target saturation range under each method, how fast the device corrects deviations, the alerts it generates, nursing workload, oxygen use and patient comfort. This substudy is part of clinical investigation FJD-EMILY-23-02, whose other substudies are registered in separate records.

Lactate/Albumin Ratio and Mortality in Respiratory Failure

This retrospective observational study aims to evaluate the association between the lactate-to-albumin ratio (LAR) measured at ICU admission and 28-day mortality in adult patients admitted to the intensive care unit with acute respiratory failure. The study will also compare the prognostic value of LAR with that of existing clinical and laboratory parameters.

The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial

The METEOR Trial will compare four implementation strategies-traditional online education, protocol-directed care, interprofessional education, and a combination of protocol-directed care and interprofessional education-to test the hypotheses that interprofessional education is superior to traditional online education as an implementation strategy in the intensive care unit (ICU) and the benefits of interprofessional education are increased when interprofessional education is paired with a clinical protocol. Additionally, the trial will also test the hypothesis that preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients are both superior to current clinical practice (i.e., conventional post-extubation oxygen therapy).

Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement

Mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. During this process, accurate measurement of transpulmonary pressure (PL) is essential to ensure the safety and efficacy of ventilation. PL is defined as the difference between alveolar pressure (Palv) and pleural pressure (Ppl). While the direct measurement of Ppl is possible, it poses a risk to tissue integrity. Thus, the primary surrogate for Ppl measurement today is esophageal pressure (Pes). However, the measurement of Pes is not without challenges. This abstract outlines the pitfalls associated with Pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. These errors can range from underestimation of Pes due to underfilled catheters to overestimation resulting from overfilled catheters. To address these challenges and optimize Pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. In this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted Mojoli method in the context of pediatric patients. This research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to Pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes

Diaphragm Response in Elderly for Acute Monitoring

Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Currently, management relies on clinical, biological, and radiological assessments, but diaphragmatic ultrasound could provide an additional tool for real-time respiratory function evaluation. This study aims to integrate this non-invasive technology into the initial assessment of patients to improve care pathways. Hypothesis : Diaphragmatic ultrasound enables reliable assessment of respiratory function and can predict the need for mechanical ventilation.

Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients With Acute Respiratory Failure and Sepsis

This is a phase 3 study designed to evaluate whether the administration of ganciclovir increases ventilator-free days in immunocompetent patients with sepsis associated acute respiratory failure. Our hypothesis is that IV ganciclovir administered early in critical illness will effectively suppress CMV reactivation in CMV seropositive adults with sepsis-associated acute respiratory failure thereby leading to improved clinical outcomes

Brain-lung Interaction During Acute Respiratory Failure

Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC. Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients. The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC. Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected. From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG. These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.

Revefenacin in Acute Respiratory Insufficiency in COPD

RARICO is a pragmatic, randomized, controlled, double-blinded, multi-center trial evaluating the safety and feasibility of nebulized revefenacin in comparison to nebulized ipratropium in patients with COPD and acute respiratory failure requiring invasive mechanical ventilation.

A Check-list Including Lung Ultrasound for ED Patients With ARF

The aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room. Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. The emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis. A diagnostic hypothesis will be made after completion of the checklist. The emergency physician can perform additional examinations and treatment after completion of the checklist. The final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization. The main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.

Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes

This is a single-center, ambispective observational cohort study of adults with acute hypoxemic respiratory failure (AHRF) receiving high-flow nasal oxygen (HFNO) as initial respiratory support. The study includes three stages. Stage 1 (retrospective derivation): the first 57 consecutive patients (May-September 2025) were retrospectively included to develop and lock a dual-domain logistic model using baseline EFI, baseline PaCO2, and 0-30 minute changes in respiratory rate (ΔRR) and SpO2 (ΔSpO2). Stage 2 (retrospective temporal validation): the later 58 patients (October 2025-March 2026) were retrospectively included, and the frozen model was directly applied without refitting; results of Stages 1 and 2 have been reported. Stage 3 (prospective validation): an independent prospective validation cohort is currently being enrolled, and the frozen model will be applied without refitting. The primary outcome is endotracheal intubation within 72 hours after HFNO initiation. This registration covers the complete study; the retrospective stages have been reported, and the prospective stage is ongoing.

INtubation With Sedation Only to Preserve Independent Respiratory Effort Trial

The INtubation with Sedation Only to Preserve Independent Respiratory Effort (INSPIRE) trial is a pragmatic, non-blinded, parallel-group, randomized clinical trial comparing the effect of intubation with sedation only (intervention group) versus intubation with sedation plus neuromuscular blockade (control group) among adults undergoing emergency tracheal intubation in the ED and ICU with regard to the outcomes of: (1) hypoxemia during intubation, (2) successful intubation on the first attempt, and (3) awake immobility and PTSD symptoms. Patients who are determined by treating clinicians to require emergency tracheal intubation and who meet eligibility criteria will be enrolled and randomly assigned to either intubation with sedation only or intubation with sedation plus neuromuscular blockade.

Mechanical Power During Pressure Controlled Versus Volume-Controlled Ventilation in Acute Respiratory Failure

This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.

Research on Respiratory Support Decision-Making for Mechanically Ventilated ICU Patients Based on a Physiological World Model

Mechanical ventilation is essential for ICU patients with respiratory failure, yet ventilator adjustment and weaning decisions remain experience-dependent and highly variable. Current single-point metrics such as the oxygenation index cannot distinguish true recovery from support-dependent stability-the same oxygenation level may reflect either. This study uses EHR data from 4,232 invasively ventilated ICU patients at Ruijin Hospital (2016-2026) to develop LAVENT, a deep learning-based physiological world model of respiratory dynamics. LAVENT learns the co-evolution of patient physiology and respiratory support, generates 96-hour multivariate trajectories under candidate FiO₂/PEEP settings, and compares alternative ventilation strategies within the same patient state. External validation uses the MIMIC-IV database (n = 29,899). This retrospective observational study uses only existing EHR data, with no prospective intervention or biospecimen collection.

Hyperangulated Versus Standard Geometry Laryngoscope Blade Trial

The Hyperangulated versus Standard Geometry Laryngoscope Blade (ANGLE) Trial is a multi-center, non-blinded, parallel-group, randomized clinical trial evaluating the effect of use of a hyperangulated video laryngoscope blade versus use of a standard geometry video laryngoscope blade. Critically ill adults undergoing tracheal intubation in participating EDs and ICUs who meet eligibility criteria will be enrolled and randomly assigned in a 1:1 ratio to either intubation using a hyperangulated video laryngoscope blade or a standard geometry video laryngoscope blade. The primary outcome is the incidence of successful intubation on the first attempt. The secondary outcome is incidence of hypoxemia during the interval between induction and 2 minutes after tracheal intubation.

Tube Size Randomized Trial During Emergency Tracheal Intubation

The BREATHE trial is a parallel-group, pragmatic, randomized clinical trial comparing the effectiveness of smaller versus larger endotracheal tubes for mechanical ventilation of critically ill adults at 7 geographically diverse centers. A total of 3,180 critically ill adults undergoing tracheal intubation in the ED or ICU will be enrolled. Enrolled patients will be randomly assigned in a 1:1 ratio to receive either a smaller endotracheal tube (a 6.5 mm endotracheal tube for patients shorter than 64 inches and a 7.0 mm endotracheal for patients at least 64 inches) or a larger endotracheal tube (a 7.5 mm endotracheal tube for patients shorter than 64 inches and a 8.0 mm endotracheal for patients at least 64 inches). Patients will be followed for 6 months after enrollment. The primary outcome will be breathlessness at 6 months. The secondary outcomes will be voice quality and swallowing at 6 months.

HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport

The HERMES Phase III study is an international, multicenter, prospective observational investigation designed to characterize the quality and safety of patient transport during advanced respiratory support. The study will enroll patients undergoing prehospital, interhospital, or intrahospital transport while receiving advanced respiratory support, including high-flow nasal oxygen (HFNO), noninvasive ventilation (NIV), or invasive mechanical ventilation, as determined by routine clinical practice. The study protocol will not assign respiratory-support modalities, transport strategies, or therapeutic interventions. The primary objective is to prospectively evaluate clinical, technical, organizational, and transport-related factors associated with the safe continuation of respiratory support throughout patient transport. Data collection will include patient characteristics, respiratory-support modality and settings, transport characteristics, physiologic monitoring, transport-team composition, oxygen and electrical power resources, equipment-related events, interruptions or modifications of respiratory support, clinical deterioration, rescue interventions, escalation of respiratory support, and other transport-associated adverse events. HERMES Phase III constitutes the prospective multicenter component of a broader research program that previously included an international survey of respiratory-support transport practices and an exploratory prospective feasibility evaluation of portable external power during ambulance transport.

Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines

The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers

This study will investigate whether a family-centered intervention that has been adapted for patients with critical illness and their caregivers is possible, acceptable, and helpful

Eduction in ImmunoSuppressive Regimen Among Kidney Transplant Recipients Patients Admitted to the Intensive Care Unit for Septic Shock and/or Acute Respiratory Failure

Kidney transplantation is the treatment of choice for end-stage chronic kidney disease. Kidney transplantation is at the first rank of solid organ transplantation in France, with 3,376 grafts performed in 2022. Immunosuppressive therapy, required to prevent graft rejection, exposes graft recipients to complications related to decreased immunity, including opportunistic infections and neoplastic complications. After the earlt post-transplantation period, up to 10% of kidney transplant recipients will require admission to the intensive care unit (ICU). The main reasons for admission are septic shock and acute hypoxemic respiratory failure. ICU stay has a significant impact on these patients with a mortality rate reaching 40%, that remains increased even after ICU discharge. Furthermore, an impact on graft function has been demonstrated, with deterioration of graft function in 1/3 of patients, and among those, up to one in two will require resumption of renal replacement therapy (RRT). Although the occurrence of septic shock or acute respiratory failure related to an infection is more common and severe, the optimal management strategy for immunosuppressors is not defined in kidney transplant recipients admitted to the ICU in those settings. Maintain a high level of immunosuppressive therapies may hinder the recovery from the acute critical condition. Furthermore, these treatments have a narrow therapeutic index; for instance, the management of calcineurin inhibitors is challenging in the ICU due to pharmacodynamic changes associated with the acute situation (distribution volume, organ failure) and the numerous potential drug interactions that carry inherent risks of overdose. the investigators hypothesize that a reduction in the level of immunosuppressive treatments could promote recovery in kidney transplant recipients admitted to the ICU for septic shock and/or acute hypoxemic respiratory failure, without adversely affecting the risk of rejection or long-term renal prognosis.

Effect of Ketamine and Etomidate During RSI on Long Term Outcomes

The RSI-LTO study collects long-term outcomes from the RSI trial (NCT05277896). One-third of adults who are intubated in the ED or ICU experience symptoms of posttraumatic stress disorder (PTSD). PTSD is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." Critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. Patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). While on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. Patients with PTSD after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that PTSD negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. Ketamine may prevent PTSD symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories In outpatients with chronic PTSD, a single dose of ketamine has been shown to reduce PTSD symptoms for up to 2 weeks. Even a modest reduction in PTSD would translate into tens of thousands of fewer cases of PTSD each year, more cases of PTSD each year than any other medical intervention evaluated to date.

Nutritional Intake in Patients on Noninvasive Ventilation: a Prospective Observational Study

The primary objective is to quantify the caloric and protein intake in adult participants with acute respiratory failure who start a noninvasive ventilation treatment. The main question is: \- Are participants meeting their caloric and protein target during noninvasive ventilation treatment? Participants will complete a five-day food diary collection starting from the initiation of noninvasive ventilation treatment.

ARrest RESpiraTory Failure From PNEUMONIA

This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.

Virtual Reality in ICU - PARTNER

This project is designed to have patients participate in a virtual environment with various tasks such as breathing exercises, games to help the brain, and techniques that promote relaxation while hospitalized in the Intensive Care Unit (ICU). The participation in research will last about 5 days and take about 15 to 45 minutes each day.