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Tundra lists 174 Mechanical Ventilation clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07908368
Pulse Wave vs. Saline Contrast EIT for Pulmonary Perfusion in ARDS
Monitoring pulmonary perfusion is crucial in critical care, especially for conditions like ARDS. Electrical Impedance Tomography (EIT) is a valuable, non-invasive tool for real-time bedside monitoring.While well-established for lung ventilation, EIT faces a challenge in perfusion imaging because the related impedance signal is very weak. Currently, two main methods are used:Saline Bolus EIT: Involves injecting a saline solution during a breath-hold to track blood flow.Pulse Wave EIT: Utilizes cardiac-induced vascular pulsations to assess perfusion.However, both methods have limitations in ARDS patients, as the disease's altered physiology can affect their accuracy. This study compares pulse wave versus saline bolus EIT for pulmonary perfusion assessment in ARDS patients and investigates the impact of different PEEP levels.
Gender: All
Ages: 18 Years - 80 Years
Updated: 2026-11-02
1 state
NCT05188092
Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU patients. The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients. The investigators hypothesize that LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation. This study is an international multicenter randomized clinical trial (RCT) in invasively ventilated ICU patients.This study will include 1,000 consecutively admitted invasively ventilated adult ICU patients, who are expected not to be extubated within the next 24 hours after randomization. Patients are randomly assigned to the intervention group, in which fluid deresuscitation is guided by repeated LUS, or the control group, in which fluid deresuscitation is at the discretion of the treating physician (not using LUS).
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-30
2 states
NCT06994442
Optimizing Pain Treatment in Children On Mechanical Ventilation
In this clinical trial, investigators want to learn more about using non-opioid pain medications for children with acute respiratory failure. Right now, doctors give these children opioids to help with pain while they are on the ventilator, but investigators don't know if this is the best way to manage their pain. Even with strong doses of opioids, more than 90% of these children still feel pain. Other pain medicines, like acetaminophen (also called Tylenol) and ketorolac (also called Toradol), are available but aren't commonly used because we don't know if they help. The goal of this clinical trial is to test if acetaminophen and/or ketorolac can improve pain control and reduce the need for stronger pain medications (opioids) in these children. To learn more about this, participants will be randomly placed in one of four study treatment groups. This means that a computer will decide by chance which group each participant is in, not the doctors running the study. Each group will receive a combination of intravenous acetaminophen, ketorolac or a harmless substance called a placebo. In this clinical trial, placebos help investigators see if the actual medications (acetaminophen and ketorolac) work better than something that doesn't contain medicine. By comparing participants who get the real medicine with those who get the placebo, investigators can find out if these medications effectively decrease pain.
Gender: All
Ages: 2 Months - 17 Years
Updated: 2026-10-29
11 states
NCT07325812
Effects of Periodic Recruitment Maneuvers on Atelectasis and Respiratory Mechanics During Elective Spine Surgery Assessed by Lung Ultrasonography
During general anesthesia, particularly in patients undergoing spine surgery in the prone (face-down) position, increased intrathoracic and abdominal pressure may reduce lung compliance and promote the development of atelectasis (partial lung collapse). Atelectasis can impair intraoperative oxygenation and may increase the risk of postoperative pulmonary complications. Alveolar recruitment maneuvers (ARM) are routinely used in anesthesia practice to reopen collapsed lung regions; however, it remains unclear whether periodic application of ARM throughout surgery provides additional benefit compared with standard single-time application. This prospective, randomized controlled clinical study aims to evaluate whether periodic alveolar recruitment maneuvers applied during elective spine surgery in the prone position reduce intraoperative atelectasis and improve respiratory mechanics compared with the standard approach of performing ARM only after positioning and before extubation. Adult patients undergoing elective spine surgery under general anesthesia will be randomly assigned to either a periodic ARM group or a standard ARM group. Lung aeration will be assessed using lung ultrasound, a non-invasive and radiation-free bedside imaging method. The primary outcome is the incidence of intraoperative atelectasis assessed before extubation. Secondary outcomes include lung ultrasound aeration scores, respiratory mechanics parameters (such as airway pressures and compliance), oxygenation indices, and the occurrence of transient intraoperative respiratory or hemodynamic events. The findings of this study may help optimize intraoperative ventilation strategies in prone spine surgery and contribute to improved perioperative respiratory safety.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-10-29
NCT07898319
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
Acute Respiratory Distress Syndrome (ARDS) is a highly heterogeneous condition, making precision mechanical ventilation challenging. Electrical Impedance Tomography (EIT) provides real-time monitoring of regional lung ventilation, but interpreting its complex spatiotemporal data relies on subjective clinical experience. This multicenter ambispective cohort study aims to develop and validate an all-in-one Artificial Intelligence Foundation Model (AutoEIT). The study consists of two phases: (1) A Retrospective Phase (data from 2020 to 2025, N=1000) to train the AutoEIT model using continuous EIT images and synchronous high-frequency ventilator waveforms; and (2) A Prospective Temporal Phase (January 2026 to December 2026, N=200) to rigorously test the model's performance in a real-world clinical setting. The AutoEIT model is a deep multi-task learning framework designed to simultaneously perform five core clinical tasks: (1) classify ARDS subphenotypes, (2) recommend individualized positive end-expiratory pressure (PEEP), (3) detect occult patient-ventilator asynchrony, (4) predict ventilation/perfusion (V/Q) ratio, and (5) continuously estimate the non-invasive PaO₂/FiO₂ ratio. Ultimately, this system aims to reduce ventilator-induced lung injury (VILI) and improve precision respiratory care.
Gender: All
Ages: 18 Years - 90 Years
Updated: 2026-10-27
1 state
NCT07896824
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
To evaluate the effectiveness of early lung recruitment using high-frequency oscillatory ventilation (HFOV) alone versus HFOV with superimposed sigh breaths in moderate-to-late preterm infants requiring invasive respiratory support at Alexandria University Children's Hospital.
Gender: All
Ages: 5 Minutes - 6 Hours
Updated: 2026-10-27
NCT07889609
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
This prospective observational cohort study aims to investigate the relationship between intra-abdominal pressure (IAP), respiratory system mechanics, and successful liberation from invasive mechanical ventilation in adult patients admitted to the intensive care unit (ICU) following emergency major laparotomy. Increased intra-abdominal pressure may impair respiratory mechanics by reducing chest wall compliance, increasing airway pressures, and limiting diaphragmatic movement. These physiological changes may contribute to prolonged mechanical ventilation and difficulties in ventilator liberation. The study will enroll 100 adult patients who undergo non-traumatic emergency major laparotomy with primary fascial closure and require invasive mechanical ventilation upon postoperative ICU admission. Intra-abdominal pressure will be measured using a standardized intravesical technique through an existing urinary catheter. Serial measurements will be performed during the first 48 hours after ICU admission, alongside simultaneous assessments of respiratory system mechanics, including static respiratory system compliance and driving pressure. The primary objectives are to evaluate the longitudinal association between IAP and static respiratory system compliance and to investigate whether early IAP trajectories are associated with time to successful liberation from invasive mechanical ventilation within 28 days. Secondary outcomes include driving pressure, mechanical ventilation status on day 7, extubation failure, ventilator-free days through day 28, and mortality. All clinical management decisions, including ventilator settings, sedation, spontaneous breathing trials, extubation, and tracheostomy, will remain under the responsibility of the treating ICU team. No study-directed therapeutic interventions will be performed.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-26
NCT07274527
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension. Although amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly present. The PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop meconium-stained amniotic fluid, confirmed using a simple, objective measurement ("meconium-crit"). Participants will be randomly assigned to receive either: Lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion. The main goal is to determine whether LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice. By using a clear definition of meconium, a LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-26
1 state
NCT07769307
Titration of PS Guided by FI : A Pilot Study
The goal of this single-center, pilot, randomized controlled trial is to evaluate the feasibility and preliminary efficacy of using the Flow Index (FI) to guide Pressure Support (PS) titration in adult patients receiving Pressure Support Ventilation (PSV) who are expected to require invasive mechanical ventilation for more than 48 hours. The main questions it aims to answer are: * Is FI-guided PS titration feasible and safe in a clinical ICU setting, as assessed by the proportion of failed safety assessments and the emergency termination rate? * Does FI-guided PS titration result in a greater proportion of data collection points with respiratory muscle pressure (Pmus) within the normal range (5-10 cmH₂O) compared to conventional PS titration based on tidal volume and respiratory rate? Researchers will compare the FI-guided PS titration group to the conventional PS titration group to see if FI-guided adjustment improves the proportion of assessments with adequate inspiratory effort (avoiding both excessive and insufficient support), and whether it leads to differences in clinical outcomes including duration of mechanical ventilation, extubation failure rate, tracheostomy rate, length of ICU and hospital stay, and in-hospital all-cause mortality. Participants will: * Be randomly assigned in a 1:1 ratio to receive either conventional PS titration (adjusting PS to achieve tidal volume of 6-8 mL/kg predicted body weight and respiratory rate of 20-30 breaths/min) or FI-guided PS titration (adjusting PS to maintain FI between 2.6 and 4.5) * Complete an intervention period with PS adjustments performed twice daily (at 8:00 AM and 8:00 PM) according to the assigned protocol * Have Pmus assessed at each data collection point to determine whether inspiratory effort falls within the target range * Undergo a 2-minute safety assessment after each PS adjustment to ensure adequate ventilation and avoid excessive airway pressures or respiratory distress * Be followed for up to 28 days after enrollment or until ICU discharge, with extended follow-up to hospital discharge or death for clinical outcome evaluation
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-23
1 state
NCT06767358
Ketamine Sedation in the ICU (KANINE) RCT
Sedation is given to intensive care unit (ICU) patients to treat discomfort, anxiety, agitation, and to help facilitate care, particularly when they require a breathing tube. Sedation is very commonly used in the ICU with North American data showing almost 40% of ICU patients get sedation to help when they are requiring a breathing machine. Various medications can be given intravenously to provide sedation in the ICU but there are side-effects associated with each such as decreasing a patient's own drive to breathe, and delirium or acute confusion, both of which are associated with worse outcomes. Also, most drugs used for sedation don't treat pain. As a result, many ICU patients are also given narcotics for pain control which can result in tolerance, dependence, and withdrawal. Ketamine is a sedating medication that also treats pain and is often used in the Emergency Department and in the Operating Room but for whatever reason is not commonly used in the ICU. The investigators are proposing a study to examine the usefulness and safety of adding an intravenous infusion of ketamine to usual care in adult patients that are on a breathing machine in the ICU. Study Methods The KANINE study is being done at hospitals across Ontario, Canada. It is a randomized controlled trial which means patients will be randomized (akin to a coin flip) to receive ketamine or usual care without ketamine. The study will be blinded which means that neither patients or the doctors will know if the patient is getting ketamine or not, those that get randomized to usual care without ketamine will get an intravenous solution that looks the same as the ketamine infusion. This is important to make sure the results aren't biased in any way. The investigators will include adult ICU patients on a breathing machine who are early in their ICU admission. As most patients will be unconscious, the investigators will ask substitute decision makers (families or caregivers) of patients for informed consent prior to the study commencing. Regardless of whether patients get randomized to ketamine or not, the investigators will make sure that all patients will be adequately sedated and have their pain managed as per usual care. Setting This study will be performed in adult ICUs across Canada. Population The investigators will include adults admitted to the ICU on a breathing machine and expected to remain mechanically ventilated beyond the calendar day after randomization. The investigators will exclude patients if: (i) they were admitted with a brain bleed, traumatic brain injury, or stroke; (ii) Admitted with uncontrolled high blood pressure; (iii) admitted with status asthmaticus; (iv); admitted to the ICU with partial thickness burns greater than 10% total body surface area or any full thickness burns; (v) if they have a history of schizophrenia; (vi) if they have very bad liver failure; (vii) if they are palliative or only for comfort care; (viii) if they are requiring very high doses of blood pressure support medication to increase their blood pressure; (ix) if they are receiving a medication that causes paralysis, sometimes used in patients with very bad lung disease; (x) if they have a tracheostomy which means a whole in their neck that they breathe through; (xi) if they are allergic to ketamine; (xii) if they've had a liver transplant in the last month; (xiii) if they are pregnant or breast-feeding. Outcomes The investigators will follow all the study patients to see if their outcomes are different depending on whether they get randomized to ketamine or not. The investigators will capture how much time they are on the breathing machine, whether they survive or die, how long they stay in the ICU and whether they require a tracheostomy which is a procedure often done on patients who require the breathing machine over a prolonged period of time. The investigators will also capture how often they get delirious and for those that get delirious how long it lasts for. The investigators will capture how much of other sedating medications study patients use such as antipsychotics and benzodiazepines. The investigators will capture outcomes such as how often study patients get post-traumatic stress disorder after leaving the ICU and how well their pain relief is addressed during their ICU stay. Finally, the investigators will capture side effects related to ketamine or other sedating drug use.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-22
1 state
NCT07886918
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure-targeted assist/control ventilation (P-A/C) who retain spontaneous breathing. Participants initiate their own breaths, with assistance from the ventilator. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter during assisted P-A/C ventilation. Researchers will adjust positive end-expiratory pressure (PEEP) across four levels. The inspiratory pressure setting will remain unchanged. Researchers will record measurements from both methods at each PEEP level.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-21
NCT07467551
Turkish Validity and Reliability of the Behavioral Indicators of Pain Scale(ESCID)
A significant proportion of patients hospitalized in intensive care units (ICUs) require mechanical ventilation, and the treatments applied during this process may cause pain. Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Although it is associated with delirium and agitation, pain is often an overlooked symptom in ICU patients, and a large proportion of mechanically ventilated patients continue to experience moderate to severe pain. The most common type of pain in critically ill patients is nociceptive pain, which may result from invasive procedures such as tracheal intubation, catheter insertion, aspiration, wound care, and patient repositioning. Additionally, the noisy and unfamiliar ICU environment and patients' inability to express themselves may further increase the perception of pain. Regular assessment of pain is associated with many positive outcomes, including more effective pain management, appropriate use of analgesic and sedative medications, and shorter duration of mechanical ventilation and ICU stay. Although self-reporting of pain is considered the gold standard, many patients receiving mechanical ventilation are unable to communicate their pain. Therefore, various behavioral pain assessment scales are used to evaluate pain in ICU patients. One of these tools is the Behavioral Indicators of Pain Scale (Escala de Conductas Indicadoras de Dolor - ESCID), which was developed to assess pain in critically ill adult patients receiving mechanical ventilation who are unable to communicate. However, a Turkish version of this scale has not yet been developed. Therefore, the aim of this study is to translate the ESCID scale into Turkish, perform its cultural adaptation, and test the validity and reliability of the Turkish version.
Gender: All
Ages: 18 Years - 85 Years
Updated: 2026-10-21
NCT07886892
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure support ventilation. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter. Researchers will adjust pressure support across six levels, recording measurements from both methods at each level.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-21
NCT07594379
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
The goal of this clinical trial is to learn whether bedside flexible bronchoscopy-guided airway clearance can improve lung aeration in adult patients who are receiving invasive mechanical ventilation and have atelectasis with a high airway secretion burden. The main questions it aims to answer are: Does bedside flexible bronchoscopy-guided airway clearance reduce the proportion of nonaerated lung tissue from baseline to day 5? Does this treatment improve other lung aeration measures, respiratory mechanics, arterial blood gas parameters, pulmonary infection score, ventilator-free days, intensive care unit length of stay, and safety outcomes? Researchers will compare usual airway care plus bedside flexible bronchoscopy-guided airway clearance with usual airway care alone to see if bronchoscopy-guided airway clearance improves lung aeration and clinical outcomes. Participants will be randomly assigned to one of two groups. Participants in the usual care group will receive standard airway management, which may include airway suctioning, postural drainage, humidification, chest physiotherapy, and other routine respiratory care. Participants in the bronchoscopy group will receive the same usual care, plus bedside flexible bronchoscopy-guided airway clearance when predefined criteria for high airway secretion burden are met. Participants will have clinical assessments during the study, including chest imaging, respiratory mechanics measurements, arterial blood gas tests, pulmonary infection score assessment, and safety monitoring. The main assessment will compare quantitative chest computed tomography findings at baseline and day 5 to evaluate changes in nonaerated lung tissue.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-21
1 state
NCT07885124
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
This randomized clinical trial compares two methods of setting positive end-expiratory pressure (PEEP) during general anesthesia in adults undergoing upper abdominal digestive surgery who are at moderate or high risk of postoperative pulmonary complications. All participants will receive lung-protective mechanical ventilation. Participants will be randomly assigned to one of two groups. In the individualized PEEP group, PEEP will be adjusted to achieve the lowest driving pressure following a lung recruitment maneuver. In the standard PEEP group, PEEP will be fixed at 5 cmH2O. The main question is whether driving pressure-guided individualized PEEP reduces the proportion of participants who develop one or more postoperative pulmonary complications during the first 7 days after surgery compared with standard PEEP.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-21
NCT06520605
Cytomegalovirus Reactivation in ICU Patients Requiring Prolong Mechanical Ventilation
Cytomegalovirus (CMV) is a latent infection virus that is widespread in the population. CMV may reactivate under certain circumstances, and its hazardous nature has been proven, especially in immunosuppressed patients. However in recent years, some studies have found that CMV reactivation also exists in apparently immunocompetent patients during their critical illness. In these non-immunosuppressed patients, the presence of sepsis and its immunomodulatory effects may lead to reactivation of dormant viral infections. Studies found the incidence of CMV reactivation in up to one-fourth to half of these non-immunosuppressed patients during their critical illness. These studies also documented significantly higher length of ICU stay and mortality in critically ill patients with CMV reactivation. CMV reactivation has also been studied in specific critically ill cohorts, exhibiting there impact on mortality. David S Y Yong et al studied the effect of CMV reactivation on mortality in immunocompetent acute respiratory distress syndrome (ARDS) patients. In a recent study, it was found that among cohort of non-immunosuppressed patients with acute respiratory distress syndrome (ARDS), CMV reactivation occurred in 27 % of patients which was associated with overall increased ICU mortality. In another study among septic shock cohort (329 patients), herpesvirus reactivations were documented in 68% patients without prior immunodeficiency and concluded that reactivations could be independently associated with mortality. However currently, no study is available investigating the CMV reactivation and it's kinetics during critical illness in non immunocompetent patients requiring prolonged mechanical ventilation. In this planned observational study, we aim to find out the prevalence of Cytomegalovirus (CMV) reactivation, viral load and it's association with the severity of illness in non immunosuppressed ICU patients requiring prolong mechanical ventilation.
Gender: All
Ages: 18 Years - 80 Years
Updated: 2026-10-20
1 state
NCT07623395
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.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-20
2 states
NCT07877350
Association of Inspiratory Effort With Dyspnea During Assisted Mechanical Ventilation in Critically Ill Patients
During assisted mechanical ventilation, breathing results from the interaction between the patient and the ventilator. Optimal titration of pressure support is essential to maintain a balance between over-assistance and under-assistance. Excessive respiratory may lead to dyspnea and cause respiratory muscle fatigue, whereas excessive assistance promotes muscle atrophy and delays weaning. Although normal inspiratory effort values in healthy subjects are well defined, acceptable limits in critically ill patients remain unclear. Inspiratory effort is traditionally quantified by the pressure-time product (PTP), but its measurement is technically demanding. Simpler indices such as swings of esophageal pressure (δPes) and airway occlusion pressure at 100 ms (P0.1) are used more often, both with important limitations. Dyspnea, a frequent and distressing symptom among mechanically ventilated critically ill patients, may serve as a physiological marker of unacceptably high effort. This single-center prospective observational study conducted in the intensive care unit (ICU) of the University Hospital of Heraklion aims to (1) determine whether the ratio mean to maximal inspiratory pressure (Pmean/Pmax) correlates more strongly with dyspnea intensity than PTP, δPmus, P0.1 and (2) identify a Pmean/Pmax threshold predictive of clinically significant dyspnea. These findings are expected to define objective upper limits of acceptable inspiratory effort and guide ventilator titration to improve patient comfort and safety.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-16
NCT07193719
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
Gender: All
Ages: 0 Years - 18 Years
Updated: 2026-10-15
NCT07874607
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.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-15
2 states
NCT07875530
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.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2026-10-15
1 state
NCT05492344
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.
Gender: All
Ages: 18 Years - 100 Years
Updated: 2026-10-15
2 states
NCT07486167
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.
Gender: All
Ages: 0 Days - 18 Years
Updated: 2026-10-15
NCT05534243
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.
Gender: All
Ages: 18 Years - Any
Updated: 2026-10-13
4 states