Clinical Research Directory

Little Lungs Study

This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.

Physiological Dead Space and Intensive Care Mortality in Mechanically Ventilated Patients

This study investigates the relationship between physiological dead space and clinical outcomes, specifically mortality and discharge status, in adult patients receiving invasive mechanical ventilation in the intensive care unit (ICU). Physiological dead space refers to ventilated but non-perfused regions of the lungs and can be quantified using the Enghoff-modified Bohr equation based on capnographic and arterial CO₂ measurements. While volumetric capnography is a valuable tool in anesthesiology and perioperative care, its use in ICU settings remains limited. By continuously monitoring physiological dead space at the bedside, this study aims to provide real-time insight into ventilation-perfusion mismatch and assess its prognostic significance in critically ill patients.

Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation

Muscle activity in the upper airway is influenced by specific states such as anesthesia, sleep, wakefulness, and the phases of respiration. The hypoglossal nerve, which innervates the genioglossus muscle, receives input from the brain's sleep-wake center, respiratory pattern-generating neurons, chemoreceptors, and airway negative pressure receptors. Preliminary activation of the genioglossus muscle and other upper airway dilators by the hypoglossal nerve occurs approximately 50-200 ms before innervation of the phrenic motor neurons and the subsequent action of the diaphragm. The forward movement of the genioglossus increases the stiffness and diameter of the upper airway, effectively counteracting collapse forces during inspiration. Assessing genioglossus function could prove critical in determining the optimal timing for extubation. This requires a methodology to evaluate the upper airway by measuring genioglossus activity in intubated patients. In the future, this could provide an objective measure for assessing suitability for extubation. This study explores a method for measuring the electrical activity of the upper airway muscles and the diaphragm in ventilated patients and correlates the results in a systematic view.

Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator

The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with Invasive Mechanical Ventilation (IMV) as parent coaches.

Determination of the Optimal Spontaneous Breathing Trial During Weaning of Mechanical Ventilation

Assessment and comparison of three spontaneous breathing trials in five specific profiles of intensive care unit and perioperative patients. A physiological cross over study

Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.

The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following: * Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS). * Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications. * Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications. Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.

Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT

Acute Respiratory Distress Syndrome (ARDS) is a serious condition where the lungs become inflamed, leading to severe breathing difficulties. Despite advances in medical care, ARDS remains a life-threatening illness with a high risk of death and long-term complications. One way doctors help ARDS patients is by using special ventilation techniques to protect the lungs from further damage. However, this often requires heavy sedation or even paralyzing medications, which can lead to other problems like delirium, muscle weakness, and longer hospital stays. Allowing patients to breathe on their own might offer benefits, but it also comes with risks. Many ARDS patients have a very strong urge to breathe, which can cause them to overexert their lungs, potentially leading to additional lung damage, known as patient selfinflicted lung injury (P-SILI). Our early research suggests that a medication called ondansetron, commonly used to prevent nausea, might help reduce this strong breathing drive in ARDS patients, possibly preventing further lung injury. The OSIRIS research program is designed to explore whether ondansetron can protect ARDS patients from P-SILI, ultimately improving their chances of survival and reducing long-term complications. The first part of this program, OSIRIS-1, is a small pilot study where we will test the feasibility of running a larger, more definitive trial. We will randomly assign ARDS patients to receive either ondansetron or a placebo, given intravenously four times a day, and monitor their heart rhythms closely to ensure safety. We will also track how well patients stick to the study plan and whether ondansetron helps reduce their breathing drive and lung strain. If successful, this research could lead to new ways of treating ARDS that rely less on heavy sedation, potentially improving outcomes for these critically ill patients and setting the stage for larger, more comprehensive studies in the future.

Hyperoxemia in the Intensive Care Unit(ICU)

In our study, to research the prevalence of hyperoxemia in adult patients treated in the intensive care unit (ICU) and its relationship with clinical outcomes. This single-center, observational study included 260 consecutive patients aged 18-85 years who received oxygen therapy in the ICU for respiratory failure. Hyperoxia was defined as SpO₂\>96% and PaO₂\>100 mmHg in the first 24 hours. Patients were divided into normoxic and hyperoxic groups, and demographic characteristics, comorbidities, ICU admission scores, mechanical ventilation requirements, ICU and hospital length of stay, and in-hospital mortality were compared.The mean age of the patients was 69.9±15.4 years, and 55.8% were male. According to SpO₂-PaO₂ criteria, hyperoxia was detected in 59.6% (n=155) of patients and normoxia in 40.4% (n=105). The groups were similar in terms of age, gender, BMI, and APACHE II score. The SOFA score and admission GCS were lower in the hyperoxic group, and the duration of mechanical ventilation, ICU, and hospital stays were significantly longer (p\<0.01 for all). In-hospital mortality was significantly higher in the hyperoxic group (82.5% vs. 50.4%; p\<0.001). In our study, hyperoxia developed in approximately two-thirds of the patients in the ICU, and hyperoxia was associated with increased mortality and length of stay. These results highlight the importance of avoiding hyperoxia when titrating oxygen therapy in critically ill patients.

Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support

Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. However, mechanical ventilation is recognised as potentially harmful, because inappropriate mechanical ventilation settings in ICU patients are associated with organ damage, contributing to disease burden. Studies revealed that mechanical ventilation is often not provided adequately despite clear evidence and guidelines. Variables at the ventilator and extracorporeal lung support device can be set automatically using optimization functions and clinical recommendations, but the handling of experts may still deviate from those settings depending upon the clinical characteristics of individual patients. Artificial intelligence can be used to learn from those deviations as well as the patient's condition in an attempt to improve the combination of settings and accomplish lung support with reduced risk of damage.

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.

Ultrasound Evaluation of Respiratory Muscles During Mechanical Ventilation Weaning in ICU Patients

Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Failure of weaning is associated with longer ventilation duration, prolonged ICU stay, and increased risk of complications and death. Therefore, simple and reliable bedside tools are needed to better understand respiratory muscle function and to help predict weaning outcomes. This prospective, observational, single-center study aims to evaluate respiratory muscle function using bedside ultrasound in adult ICU patients with pneumonia receiving invasive mechanical ventilation. The diaphragm, parasternal intercostal muscles, and anterior scalene muscles will be assessed using ultrasound during the weaning process. Measurements will be performed serially, starting from the first day when patients demonstrate meaningful spontaneous breathing effort and continuing until successful extubation, tracheostomy, or ICU mortality. Ultrasound measurements of muscle thickness and thickening fraction will be analyzed in relation to weaning outcomes. In addition, ventilator parameters and commonly used weaning indices will be recorded at the time of each ultrasound assessment. The findings of this study are expected to improve understanding of respiratory muscle involvement during weaning and may contribute to earlier identification of patients at risk of weaning failure.

Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients

In intensive care, respiratory physiotherapy is an integral part of the daily care of patients under invasive mechanical ventilation. Its goals are to improve the clearance of bronchial secretions to allow for the resolution of atelectasis and alveolar recruitment, thereby enhancing respiratory mechanics and gas exchange. The most widespread technique in France is external expiratory compression of the chest. The effectiveness of this technique depends on the selection of patients (it seems to be more effective in patients with higher secretion levels) and on the practical implementation of the technique (favoring brief and vigorous compressions at the beginning of expiration). However, the effect of the artificial ventilator settings, particularly the ventilatory mode used during the respiratory physiotherapy session, has never been evaluated. The two most commonly used ventilatory modes worldwide are Volume Assist Control Ventilation (V-ACV) and pressure support ventilation (PSV). In this unit, respiratory physiotherapy under artificial ventilation is performed daily on patients with artificial ventilation with abundant secretions, regardless of the ventilatory mode.

Evaluation of Rehabilitation Practices in the Intensive Care Unit

This observational study aims to describe the number of rehabilitation procedures performed per patient during their stay in French-speaking adult intensive care units undergoing invasive mechanical ventilation (average rehabilitation ratio). The study aims to determine the actual rehabilitation ratio, i.e. the number of rehabilitation procedures divided by the number of critical care hospital days (censored at day 28 from the start of invasive mechanical ventilation), provided to patients undergoing invasive mechanical ventilation. The rehabilitation procedure will remain the same, and ICU teams will only record the number of procedures performed per day.

Assessment of Ventilation Parameters for Extubation Prediction in ICU

The study aims to research the values of mechanical power, driving pressure, and elastic power in predicting the duration of mechanical ventilation in critically ill patients undergoing invasive mechanical ventilation. This will help determine which patients may be considered for early extubation, which patients should wait for extubation, and the patients where extubation is anticipated to be prolonged, attention should be paid to initiating preparations for alternative treatment methods like tracheostomy early.

The External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation

With the development of perinatal medicine, more and more newborns with respiratory failure can be treated due to the use of respiratory support technology. However, long-term invasive mechanical ventilation treatment can lead to a series of complications such as ventilator-associated pneumonia, atelectasis and air leakage syndrome, and increase the risk of bronchopulmonary dysplasia and neurodevelopmental lag of premature infants. It also leads to longer hospital stays and higher hospital costs. To shorten the invasive mechanical ventilation time and improve the success rate of withdrawal through various ways is the development direction of neonatal mechanical ventilation therapy. Respiratory muscle atrophy is common and rapid in children receiving invasive mechanical ventilation, and is an important cause of ventilator dependence and withdrawal failure. The diaphragm of newborns is the main respiratory muscle, of which the diaphragm type 1 endurance fiber accounts for only about 30%, far lower than the proportion of about 55% in adults, so the diaphragm of newborns is more prone to fatigue. Previous animal experiments and clinical studies in children and adults have confirmed that diaphragmatic pacing therapy applied to patients with long-term invasive mechanical ventilation can prevent diaphragmatic atrophy, reverse diaphragmatic injury, significantly improve diaphragmatic thickness, improve diaphragmatic anti-fatigue ability, thereby increasing lung ventilation, relieving dyspnea, and achieving the effect of assisted extubation. The neonatology Department of the Children's Hospital Affiliated to Chongqing Medical University started neonatal external diaphragm pacemaker treatment in 2022, and has completed 1383 cases so far, initially showing the effectiveness and safety of external diaphragm pacemaker treatment in neonatal population. But so far, there is no systematic evaluation of clinical intervention effect of external diaphragm pacemaker treatment on neonatal respiratory failure patients at home and abroad. Based on this, the project team intends to conduct a prospective randomized controlled study to systematically evaluate the safety of external diaphragm pacemaker in preterm infants requiring invasive mechanical ventilation for ≥7 days at 28 to 35 weeks of gestation, and to evaluate the efficacy of external diaphragm pacemaker in adjuvant extubation.

Preemptive Treatment With Acyclovir in Intubated and Mechanically Ventilated Patients With Herpes (PTH2)

This research aims to assess the interest of preemptive treatment with Acyclovir in mechanically ventilated patients with reactivation of Herpes simplex (HSV) in the throat and failure of one organ or less. HSV reactivation is common in patients hospitalized in an intensive care unit (ICU) on invasive mechanical ventilation. It begins at the oropharyngeal level (incidence up to 20-50%), then progresses downward with contamination of the distal airways (reported incidence of 20-65%). HSV reactivation is associated with high mortality. The investigators aim to disable that, in mechanically ventilated patients with HSV reactivation in the throat and failure of one organ or less, preemptive treatment with Acyclovir may reduce mortality. To answer the question posed in the research, it is planned to include 246 people hospitalized in intensive care on invasive mechanical ventilation, presenting with HSV reactivation of the throat and one organ failure or less.