Clinical Research Directory

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair

The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing biventricular repair for congenital heart disease (CHD) with cardiopulmonary bypass. The primary hypothesis is that optimizing end-expiratory lung volume through a standardized PEEP titration maneuver improves cardiac performance and lung function. Secondary objectives are to evaluate whether this strategy reduces duration of mechanical ventilation, improves hemodynamics and ventilation-perfusion matching, and decreases the need for vasopressor support.

Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children

The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1. study) children undergoing biventricular repair of their congenital heart disease (CHD) with cardiopulmonary bypass and 2. study) in children with severe respiratory failure at risk for or need for ECMO. The main questions it aims to answer are: Main hypotheses of CHD study: Does a standardized PEEP-Titration maneuver, to optimize end-expiratory lung volume improve: * cardiac performance * lung function Does it make a difference in: * length of ventilation * ventilation/perfusion mismatch of the lung * need for vasopressor support? Main hypotheses of ECMO study: Does a LVOM in children/infants with severe respiratory failure /ARDS * improve lung compliance and gas exchange * facilitate lung protective ventilation according to PALICC-2 guidelines * improve lung aeration and V/Q-matching assessed with EIT Does it make a difference in * need for ECMO * duration of ECMO runs * hemodynamics stability

VC-AF vs FCV in Obese Patients Undergoing Laparoscopic Surgery

Obesity adversely affects respiratory physiology by reducing lung volumes and compliance and increasing airway resistance and alveolar collapse. These effects are further aggravated by pneumoperitoneum during laparoscopic surgery, increasing the risk of impaired oxygenation and ventilator-induced lung injury (VILI). Mechanical power (MP) reflects the total energy transferred to the respiratory system during mechanical ventilation and is influenced by tidal volume, respiratory rate, airway pressures, flow, and PEEP. Increased airway and driving pressures may contribute to higher mechanical power and lung injury, particularly in obese patients undergoing laparoscopic surgery. This study aims to compare flow-controlled ventilation (FCV) and volume-controlled ventilation with autoflow (VC-AF) in obese patients undergoing laparoscopic surgery in terms of airway pressures, driving pressure, and mechanical power. The investigators hypothesize that FCV may reduce airway pressures, driving pressure, and mechanical power compared with VC-AF, potentially decreasing the risk of VILI. The effect of FCV on oxygenation will also be evaluated as a secondary outcome.

Planned Operating-Room Extubation After Cardiac Surgery

The goal of this clinical trial is to learn whether removing the breathing tube in the operating room after cardiac surgery helps adults recover faster than removing the breathing tube later in the intensive care unit (ICU), without increasing the risk of complications. The main questions it aims to answer are: * Does planned operating-room extubation increase the amount of time patients are alive and free from breathing-machine support and significant blood-pressure or heart-support medications during the first 72 hours after surgery? * Is planned operating-room extubation as safe as standard early ICU extubation with respect to important complications such as death, stroke, reoperation for bleeding, breathing failure requiring additional support or reintubation, and unplanned ICU readmission? Researchers will compare planned operating-room extubation with standard enhanced-recovery care in which patients remain intubated when leaving the operating room and are extubated in the ICU, with a target of within 6 hours after surgery when clinically appropriate. Participants will: * Provide informed consent before surgery * Be randomly assigned to one of the two extubation strategies * Receive otherwise standard cardiac surgical, anesthesia, and ICU care * Have routine clinical information collected during the first 72 hours after surgery and through hospital discharge * Complete a short questionnaire about their recovery on postoperative day 2 * Have their health status followed to 30 days after surgery If a participant assigned to operating-room extubation develops a clinical concern that makes immediate extubation unsafe, the treating team may keep the breathing tube in place and transfer the participant to the ICU while continuing standard care.

Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome

Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.

The ED-AWARENESS-2 Trial

The investigators will screen all mechanically ventilated ED patients for study eligibility and will enroll all consecutive patients satisfying inclusion and exclusion criteria. The study design is a pragmatic, multicenter, stepped wedge cluster randomized trial, enrolling at five sites over a 3-year period, divided into six time periods of six months. Prior to the study, each site will be randomized to their position within the design. One site will cross to the intervention period (i.e. succinylcholine as default neuromuscular blocker) every six months from the 2nd to 6th time period. Cluster order will be determined by computer-based randomization. To begin, each site will be exposed to control conditions; by the end of the study, each site will be exposed to intervention conditions. Patients in the control phase will receive usual care, and this phase will be entirely observational. After six months, a site will enter a 2-month transition phase. In this phase, the investigators will implement the intervention, similar to how they have implemented other ED-based interventions for mechanically ventilated patients. The investigators will engage and educate ED clinicians on the importance of AWP prevention and the study objectives. The intervention framework relies on the use of "nudges", without restricting choice. The use of neuromuscular blockers (i.e. "paralytic" medications) is already part of routine care in the ED in order to facilitate endotracheal intubation and initiation of mechanical ventilation for patients with acute respiratory failure. The two most common neuromuscular blockers used in the ED are succinylcholine and rocuronium. The preliminary data show a strong association between rocuronium (a longer-acting neuromuscular blocker) use and AWP. Therefore, this study aims to improve care by educating caregivers on AWP and the use of the neuromuscular blockers, which are already routinely used, and studying that process in a rigorous fashion. The default neuromuscular blocker in the intervention phase will be succinylcholine. Succinylcholine will be the default over rocuronium because: 1) it has safely been the default neuromuscular blocker of choice in the ED for \>40 years ; 2) its 5-minute duration of action greatly reduces AWP risk; 3) the preliminary data regarding an increased risk of AWP with rocuronium and 4) ED rocuronium use has increased despite no patient-centered studies showing benefit over succinylcholine. Passive alerts (i.e. graphics, pocket cards) will also be strategically placed in the ED, and active alerts will be used as reminders before every nursing shift (i.e. "the huddle"). After this transition phase, the site will begin the intervention phase, and patients will again receive clinician-directed care, just after the intervention.

Intraoperative Driving Pressure and Postoperative Lung Ultrasound Score in Robot-Assisted Radical Prostatectomy

The primary objective of this study is to evaluate the relationship between intraoperative driving pressure and postoperative lung ultrasound scores in patients undergoing robot-assisted laparoscopic radical prostatectomy. During this specific surgery, factors such as pneumoperitoneum and patient positioning can significantly affect respiratory mechanics. Postoperative lung condition will be objectively assessed using the lung ultrasound score (LUS). The findings may provide valuable insights for optimizing intraoperative mechanical ventilation strategies.

CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients

Patients who survive critical illness usually experience long-lasting physical and psychological impairments, which are often debilitating. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allows critically ill patients who are mechanically ventilated (MV) to gently exercise their legs while in the ICU. The main goal of this study is to determine whether critically ill MV adults recover faster if they receive early in-bed cycling than if they do not. Another objective is to determine whether in-bed cycling is a cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be enrolled in the study. Following informed consent, patients will be randomized to either (1) early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients' strength and physical function will be measured throughout the study. If early in-bed cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.

Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome

Tracheostomy is one of the most common procedures in the intensive care unit in patients who need prolonged invasive mechanical ventilation. There is controversy in the literature regarding the ideal timing for performing tracheostomy in critically ill patients. Early tracheostomy may be associated with a decrease in ventilation days and hospitalization. We would like to investigate whether in ventilated patients with Guillain Barre syndrome, early tracheostomy will be associated with decreased ventilation days, decreased mortality and shorter hospital and ICU length of stay.

Controlled Ventilation During Anesthetic Emergence

Absolutely - for a \*\*ClinicalTrials.gov-style Brief Summary\*\*, I'd keep it simple and patient-friendly like your example: The goal of this clinical trial is to learn whether maintaining controlled mechanical ventilation during emergence from general anesthesia can improve the quality and safety of recovery compared with conventional supported weaning in adults undergoing surgery with a breathing tube. The main questions it aims to answer are: * Does controlled mechanical ventilation during emergence reduce coughing and the duration of coughing before removal of the breathing tube? * Does it reduce agitation during emergence from anesthesia? * Does it reduce the need for breathing support, such as continuous positive airway pressure (CPAP), after removal of the breathing tube? * Are there differences in oxygen levels, blood pressure, heart rate, airway complications, or the time required for removal of the breathing tube? Researchers will compare controlled mechanical ventilation with conventional supported weaning during emergence from general anesthesia. Participants will: * Receive general anesthesia with a breathing tube for their planned surgery * Be assigned to either controlled mechanical ventilation or conventional supported weaning during emergence from anesthesia * Have their coughing, agitation, oxygen levels, blood pressure, heart rate, and airway-related events monitored during emergence * Have the time to removal of the breathing tube and any need for additional breathing support recorded This version is deliberately written in \*\*plain language rather than manuscript language\*\*, which is much closer to what ClinicalTrials.gov expects for the brief summary.

Impact of an Early and Extended Rehabilitation Program Combining Individually Tailored Nutrition and Physical Activities on Patient Outcomes After Invasive Mechanical Ventilation and Vasopressor Therapy in the ICU

The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care. From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.

Prognostic Estimates Among ICU Clinicians

One challenge with decision making for mechanically ventilated is that their prognosis is often uncertain. The ProVent-14 score incorporates clinical variables measured on the 14th day of mechanical ventilation to predict risk of death in one year. The ProVent-14 is easy to calculate has been externally validated. However, it is unclear how often clinicians use the ProVent-14 score to predict long-term outcomes for patients requiring 14 days of mechanical ventilation or if it helps clinicians make more accurate predictions. The purpose of this study is to determine whether ICU clinicians who receive a patient's ProVent-14 score make more accurate predictions for mortality at one year than ICU clinicians who do not.

Heart Rate Variability for Practitioner Stimulated Reflection and Decision-making Optimisation

At the heart of healthcare is the interaction between healthcare practitioners and patients. It is believed that optimisation of this interaction can improve patient relevant outcomes, safety and patient experience. Through utilisation of practitioner physiological data, heart rate variability (HRV), to help practitioners make better decisions and optimise practice, it is considered possible to improve decision making around patient care and improve outcomes and safety. The modern intensive care unit (ICU) is a dynamic data rich environment requiring rapid and accurate decision making. Advances in ventilator technology, electronic patient monitoring and electronic health records (EHR) have provided exponential growth in data produced for patients and the need for complex decision making. However, data overload and alarm fatigue can result in poor understanding and a delayed response from the practitioner in addressing the patient's needs. The aim of this study is to present and evaluate a psychophysiology training approach for practitioners derived from their cardiovascular response through the course of the working day, this will be measured using heart rate variability (HRV). Practitioner HRV has been shown to be linked to work related stress and is considered a biomarker of decision-making.

Reverse Trigger Phenotypification and Response to Ventilatory Adjustments

The goal of this prospective observational study is to describe the incidence of reverse trigger (RT) in mechanically ventilated patients with diagnosis of acute respiratory distress syndrome (ARDS). The main questions it aims to answer are: * Real incidence of RT based on continuous monitoring * The response to mechanical ventilatiory adjustments Participants will be included as soon as neuromuscular blockers (NMB)/sedation is stopped or in case of spontaneous respiratory efforts detection, whatever happens first. Continuous monitoring will be performed by esophageal manometry until switch to a pressure support (spontaneous) mode, restart of deep sedation/neuromuscular blockers by medical indication, or death. In order to allow detection of possible RT in patients with ongoing sedation/NMB, mechanical ventilator waveforms will be screened every 1-2 hours by investigators and critical care physicians with at least 1 year of specific training in detection of dyssynchronies.

Early Switch From Controlled to Assisted Ventilation

The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg. The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.

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.

Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock

This prospective observational cohort study aims to evaluate the prognostic value of serial bedside ultrasound assessment of diaphragmatic function in adult patients with septic shock. Diaphragmatic excursion, thickness, and thickening fraction will be assessed using point of care ultrasound at baseline and serially during the first 72 hours of intensive care admission. Dynamic changes in these parameters will be analyzed in relation to the development of respiratory failure, need for invasive mechanical ventilation, duration of mechanical ventilation, weaning and extubation outcomes, length of ICU stay, and mortality. The study will determine whether dynamic diaphragmatic ultrasound assessment can provide an early, non-invasive predictor of respiratory failure and adverse clinical outcomes in patients with septic shock.

Impact of Early Low-Calorie Low-Protein Versus Standard Feeding on Outcomes of Ventilated Adults With Shock

Among critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.

Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.

The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective qualitative and quantitative data. Actual extubation readiness is defined as successful extubation, defined as no reintubation in the 7 days following extubation. Key research questions are: How do clinicians assess extubation readiness in this population? Does this assessment correlate with actual extubation success? What factors (reasons, clinical status, ventilatory parameters) are associated with extubation readiness? Patients born before 28 weeks gestational age and admitted to the neonatal intensive care unit (NICU) within the first 24 hours are be included. The attending physician will complete a prospectively administered questionnaire with open-ended and multiple-choice questions to daily assess the decision and rationale for extubation or non-extubation of patients mechanically ventilated during the first 15 days of life. Patient characteristics, respiratory outcomes, and mortality will be recorded until the end of hospitalisation and/or definitive weaning from any ventilatory support or supplemental oxygen.

Incidence and Determinants of Joint Contractures in Mechanically Ventilated ICU Patients

This prospective observational cohort study aims to evaluate the incidence and determinants of joint contracture development in mechanically ventilated adult patients admitted to the intensive care unit (ICU). Prolonged immobilization, deep sedation, and neuromuscular blockade are common in critically ill patients and may contribute to musculoskeletal complications, including joint contractures, which can adversely affect functional outcomes and rehabilitation after ICU discharge. Adult patients who are mechanically ventilated, immobilized, and have impaired consciousness will be consecutively enrolled and followed during their ICU stay. Joint range of motion will be assessed using standardized passive range of motion (PROM) measurements performed with a goniometer at predefined intervals by trained assessors. Joint contracture will be defined as a reduction of at least 33% in passive joint range of motion compared with normal reference values. This study is non-interventional, and all patients will receive routine ICU care and standard physiotherapy according to institutional protocols. No additional procedures or interventions will be applied for research purposes. Demographic characteristics, clinical variables, and ICU-related factors will be recorded to explore potential associations with contracture development. The findings of this study are expected to provide prospective data on the burden of joint contractures in mechanically ventilated ICU patients and to identify modifiable risk factors that may inform future preventive and rehabilitative strategies in critical care practice.

HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport

The HERMES Phase I-II study was a two-phase observational investigation designed to characterize contemporary practices and safety-related challenges associated with the transport of patients requiring advanced respiratory support and to assess the operational feasibility of portable external electrical power during ambulance transport. Phase I consisted of an international electronic cross-sectional survey of healthcare professionals involved in noninvasive ventilation (NIV) management or patient transport. The survey evaluated reported transport indications, ventilator type and positioning, respiratory interfaces, transport-team composition, and perceived patient-, equipment-, and environment-related problems. Phase II was a prospective descriptive feasibility evaluation involving 25 ambulance transports performed in Albacete and Bilbao, Spain. Patients were transported while receiving high-flow nasal oxygen (HFNO), rescue NIV, or invasive mechanical ventilation. A portable external power supply was used to support continuity of powered respiratory-support equipment during transport. The primary technical feasibility outcome was successful completion of transport while maintaining respiratory support without reported power interruption, clinically relevant equipment alarm, or technical failure. The two phases were analyzed independently and were intended to characterize respiratory-support transport practices and evaluate technical and operational feasibility rather than establish comparative effectiveness, clinical superiority, or prevention of clinical deterioration.

Dexmedetomidine for Sedation in Patients Requiring Mechanical Ventilation is Associated With a Lower Incidence of Delirium

This retrospective cohort study will include 412 adults mechanically ventilated \>24 hours in intensive care unit in sohag university hospital between 2024 and 2026). Participants will be assigned to either, EGDS group ( equal to 208 ) or conventional sedation group (equal to 204 ). The main endpoint will be measured is the incidence of delirium in ICU , measured by the Confusion Assessment Method for the ICU (CAM-ICU). Secondary endpoints will be the number of the days free from ventilation at 28 days (VFDs), ICU length of stay (LOS) in the ICU, and the death during hospitalization.

Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery

In an international multicenter randomized clinical pilot trial, intraoperative flow-controlled ventilation (FCV) will be compared with volume-controlled ventilation (VCV) in patients scheduled for (open, video- or robot-assisted) thoracic surgery with one-lung ventilation (OLV). This pilot trial is designed to test the feasibility and safety of FCV during all phases of intraoperative ventilation, and in particular during OLV, and to inform the design of a future trial testing the efficacy of FCV with regard to postoperative outcomes, including postoperative pulmonary complications (PPC). The ventilation modes are conducted with CE-marked medical devices (anesthesia ventilators or medical ventilators), however these medical devices themselves are not under investigation. All CE-marked standard medical devices from varied manufacturers in use at the participating study centers will be used in full accordance with their instructions for use. FCV has shown safety and feasibility in various surgical settings, including thoracic surgery with OLV, however its feasibility in a multicenter trial has not been investigated yet.

Early Versus Deferred De-escalation From Controlled Ventilation After a 48-Hour Landmark of Physiological Stability

This retrospective target trial emulation evaluates the optimal timing of de-escalation from controlled to assisted mechanical ventilation in critically ill adults. Using the clone-censor-weight (CCW) estimator with stabilised inverse-probability-of-censoring weights, we compare two strategies over a 24-hour grace window following a 48-hour landmark: early de-escalation (step-down in ventilatory support mode or successful extubation) versus deferred de-escalation (support maintained or increased). The primary outcome is 28-day in-hospital mortality. Secondary outcomes are 28-day restricted mean survival time (RMST) and ventilator-free days (VFD28). The study uses MIMIC-IV v2.2 (derivation cohort, n=1,902 analysable) with external validation in eICU-CRD v2.0 (validation cohort, n=10,957 analysable). All analyses employ stabilised IPCW with bootstrap confidence intervals, including six sensitivity and robustness analyses (extended covariate adjustment, alternative weight truncation, doubly robust AIPW estimator) and an exploratory FiO₂×PEEP threshold grid.