[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jian-Xin Zhou\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,73,98,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100602873","pulmonary-microbiota-changes-and-clinical-outcomes-in-neurosurgical-icu-patients-with-artificial-airways-100602873",false,"NCT07129174","Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways","Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Patients must meet all of the following conditions to be eligible for inclusion:\n\n  1. First admission to the Intensive Care Unit (ICU).\n  2. Assessed by an ICU specialist as expected to require artificial airway support (e.g., mechanical ventilation) for more than 24 hours.\n  3. Neurosurgical patients. Postoperative neurosurgical patients are defined in this study as those who have undergone surgery for: brain tumors, Subarachnoid hemorrhage, Traumatic brain injury\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded:\n\n  1. Age under 18 years\n  2. Pregnancy\n  3. Pre-existing spinal cord injury\n  4. History of chronic pulmonary diseases, including: Chronic bronchitis, Chronic obstructive pulmonary disease (COPD), Bronchial asthma, Bronchiectasis, Interstitial lung disease, Pleural effusion\n  5. Pre-existing immunosuppressive conditions, including: Systemic immunomodulatory therapy, Chemotherapy, HIV infection, Other congenital or acquired immunodeficiency disorders\n  6. Receipt of systemic antimicrobial therapy within the past 3 months\n  7. Diagnosis of primary lung cancer or lung metastases from other tumors\n  8. History of partial lung resection for any reason","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","28 Days","OBSERVATIONAL","After neurosurgery, many patients need to stay in the intensive care unit (ICU) and use a breathing machine (mechanical ventilation) because of issues like decreased consciousness, weak breathing, or poor airway protection. During this period, the natural balance of bacteria in the lungs-known as the lung microbiota-can be disturbed by surgery, antibiotics, and airway procedures. This may reduce healthy bacteria and allow harmful bacteria to grow, increasing the risk of lung infections such as ventilator-associated pneumonia (VAP).\n\nThis study will follow 220 postoperative neurosurgical ICU patients at three centers: Beijing Tiantan Hospital, Beijing Shijitan Hospital, and Beijing Anzhen Hospital from August 2025 to August 2026. These patients will include those undergoing surgery for brain tumors, brain hemorrhage, or traumatic brain injury. Airway secretion samples (tracheal aspirates) will be collected shortly after surgery and at several subsequent time points to assess how lung bacteria change over time while patients are using a breathing machine.\n\nUsing advanced laboratory methods, the investigators will measure both the amount and types of bacteria in the lungs. The aim is to determine how these changes are related to patient outcomes, such as the occurrence of lung infections.\n\nThe results of this study may contribute to earlier detection of lung infections and the development of personalized treatment plans to improve recovery in ICU patients after neurosurgery.",[25,26,27],"Ventilator-Associated Pneumonia (VAP)","Intensive Care Unit (ICU) Patients","Microbiome Dysbiosis",[25,29,30],"Intensive care unit (ICU)","Pulmonary Microbiota","RECRUITING","2026-05-19",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":35},"2025-08-30",{"date":39,"type":20},"2026-08-30",{"name":41,"class":42},"Jian-Xin Zhou","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100590712","use-of-nasal-pressure-to-assess-inspiratory-effort-under-different-oxygen-treatments-100590712","NCT06970990","Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments","Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments: a Prospective Physiological Study","Inclusion Criteria:\n\n1. No mechanical ventilation required,Able to tolerate oxygen therapy via nasal cannula, standard face mask, or nasal high-flow oxygen therapy;\n2. Respiratory stability:Capable of spontaneous breathing with effective cough for secretion clearance.Oxygen saturation (SpO₂) \\> 90% or PaO₂\u002FFiO₂ ≥ 150 mmHg when receiving nasal cannula oxygen at 3 L\u002Fmin;\n3. Hemodynamic stability:Heart rate (HR) ≤ 120 bpm;Systolic blood pressure (SBP) 90-150 mmHg;No vasoactive medications OR norepinephrine dosage \\\u003C 0.1-0.2 μg\u002Fkg·min (or equivalent doses of other vasoactive agents);\n4. Metabolic stability;\n5. Compliance with medical instructions.Able to follow prescribed tasks.Esophageal pressure monitoring catheter already in place;\n6. Patient or legal guardian agrees to participate and has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years;\n2. Pregnancy;\n3. Hemodynamic instability:Mean arterial pressure (MAP) \\\u003C 60 mmHg.Heart rate (HR) \\> 120 bpm or \\\u003C 60 bpm;\n4. Respiratory instability:Respiratory rate (RR) \\> 35 bpm.Oxygen saturation (SpO₂) \\\u003C 90%;\n5. Neuromuscular diseases or phrenic nerve injury;\n6. Recent trauma or surgery involving the trachea, esophagus, neck, or chest.Contraindications to esophageal catheter placement or inability to monitor esophageal pressure;\n7. Nasal obstruction or anatomical abnormalities:Complete nasal obstruction.Severe anatomical abnormalities (e.g., severe septal deviation, nasal polyps, or tumors) preventing catheter placement or compromising ventilation;\n8. High-risk craniofacial conditions:Severe facial trauma or skull base fracture with risk of catheter misplacement into the intracranial space.Active epistaxis or incomplete healing after nasal surgery;\n9. Bleeding risk:Severe coagulopathy.Esophageal\u002Fgastric varices or other conditions predisposing to hemorrhage.",{"count":52,"type":20},26,"INTERVENTIONAL",[55],"NA","The aim of this study was to investigate the effects of different oxygen therapy modalities (including nasal cannula oxygen, mask oxygen and high-flow nasal cannula oxygen) on the correlation between Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of nasal pressure and esophageal pressure and their underlying mechanisms under different conditions of oxygen therapy, to analyse the effects of oxygen therapy parameters on the relationship between the two, and to explore the feasibility of nasal pressure as a non-invasive monitoring indicator, in order to replaceor supplement esophageal manometry in clinical practice, especially in patients with respiratory distress and instability.Meanwhile, this study will also evaluate the effects of different oxygen therapy modalities on patients' respiratory mechanics and comfort, provide a scientific basis for the clinical selection of individualised oxygen therapy regimens, and ultimately provide new physiological evidence for the management of oxygen therapy in patients with acute respiratory failure in the intensive care unit (ICU) and outside the ICU, promote the development of non-invasive monitoring technology, and improve the clinical prognosis and therapeutic experience of patients.",[58,59],"Critical Care","Inspiratory Effort",[61,62,63,64],"Esophageal pressure","inspiratory effort","oxygen treatments","Nasal Pressure","2025-05-20",{"date":67,"type":35},"2025-05-22",{"date":65,"type":35},{"date":70,"type":20},"2025-12-30",{"name":41,"class":42},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":53,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":72},"100578854","comparison-of-physiological-effects-of-two-high-flow-tracheal-oxygen-versus-t-piece-during-spontaneous-breathing-trials-100578854","NCT06816706","Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials","Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients","Inclusion Criteria:\n\n1. Mechanical ventilation for more than 24 hours\n2. Considered by the physicians for the readiness to wean and ready for spontaneous breathing trials\n\nExclusion Criteria:\n\n1. Age younger than 18 years old\n2. Pregnancy\n3. Hemodynamic instability (mean arterial pressure \\\u003C60 mmHg, heart rate \\>140 or \\\u003C60 bpm)\n4. Respiratory and oxygenation instability (respiratory rate \\> 35bpm or oxygen saturation measured by pulse oximetry \\\u003C90%)\n5. Neuromuscular diseases or phrenic nerve injury\n6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach\n7. Pneumothorax or placement of a chest drainage\n8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)\n9. Anticipating withdrawal of life support",{"count":81,"type":20},20,[55],"Spontaneous breathing trials (SBT) are essential for assessing extubation tolerance, yet optimal approaches are debated. High-flow nasal oxygen offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. While high-flow tracheal oxygen can also be used as an SBT method, it has reduced physiological effects due to bypassing the upper airway with a more open circuit. To enhance this limitation, investigators developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase expiratory resistance and airway pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow tracheal oxygen versus T-piece during SBT.",[58,85,86],"Oxygen Therapy","Mechanical Ventilation",[88,89,90],"high-flow tracheal oxygen","T piece","spontaneous breathing trial","2025-03-20",{"date":93,"type":35},"2025-03-21",{"date":95,"type":35},"2025-03-01",{"date":70,"type":20},{"name":41,"class":42},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":53,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":72},"100578857","comparison-of-physiological-effects-of-two-types-of-high-flow-oxygen-therapy-in-tracheostomized-patients-100578857","NCT06816745","Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients","Comparison of Physiological Effects of Standard and Modified High-Flow Oxygen Therapy in Tracheostomized Patients","Inclusion Criteria:\n\nTracheostomy with stable spontaneous breathing.\n\nExclusion Criteria:\n\n1. Age younger than 18 years old\n2. Pregnancy\n3. Hemodynamic instability (mean arterial pressure \\\u003C60 mmHg, heart rate \\>140 or \\\u003C60 bpm)\n4. Respiratory and oxygenation instability (respiratory rate \\> 35bpm or oxygen saturation measured by pulse oximetry \\\u003C90%)\n5. Neuromuscular diseases or phrenic nerve injury\n6. Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach\n7. Pneumothorax or placement of a chest drainage\n8. Contraindication to electrical impedance tomography (EIT) (implantable defibrillator)\n9. Anticipating withdrawal of life support",{"count":81,"type":20},[55],"High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.",[58,85,109],"Tracheostomy",[88,111],"tracheostomy","NOT_YET_RECRUITING","2025-02-06",{"date":115,"type":35},"2025-02-10",{"date":117,"type":20},"2025-02-20",{"date":70,"type":20},{"name":41,"class":42},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":53,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":72},"100512318","the-clinical-feasibility-and-validity-of-pmivent-to-access-inspiratory-effort-during-pressure-support-ventilation-100512318","NCT05950893","The Clinical Feasibility and Validity of PMIvent to Access Inspiratory Effort During Pressure Support Ventilation","The Clinical Feasibility and Validity of Simple Measurement of Inspiratory Muscle Pressure Index (PMIvent) to Access Inspiratory Effort During Pressure Support Ventilation","Inclusion Criteria:\n\nAdult acute respiratory failure patients undergoing mechanical ventilation were screened daily and enrolled 24 hours after switching to PSV mode\n\nExclusion Criteria:\n\n1. age younger than 18 years old or older than 85 years\n2. known pregnancy and parturient\n3. chronic occlusive pulmonary diseases\n4. gastric, esophageal injury\n5. barotrauma\n6. diaphragm dysfunction\n7. intracranial hypertension and brain stem injury\n8. consciousness level decreased (RASS less than -2 scores)\n9. Anticipating withdrawal of life support and\u002For shift to palliation as the goal of care.","85 Years",{"count":129,"type":20},25,[55],"It is critical to maintain a relatively normal inspiratory effort during pressure support ventilation (PSV), the support level should be adjusted to match the patient's inspiratory effort. The inspiratory muscle pressure index (PMI) can reflect the elastic work of the respiratory system at the end of inspiration and has a significant correlation with inspiratory effort, and it has the outgoing advantages of being non-invasive and easy to obtain. Previous studies on PMI were based on physiological research and experimental conditions (PMIref), which require special pressure monitoring devices and software to collect and measure airway pressure. If PMI is going to be used in clinical practice, it is necessary to find a simple measurement method of PMI to replace PMIref. Most ventilators have airway pressure monitoring and end-inspiratory holding functions, and PMI can be measured by freezing the ventilator screen (PMIvent). The overall aim of this study was to determine PMIvent's clinical feasibility and validity for accessing inspiratory effort during PSV.",[86],[134,62,135],"pressure support ventilation","inspiratory muscle pressure index","2024-07-23",{"date":138,"type":35},"2024-07-25",{"date":140,"type":35},"2023-03-25",{"date":142,"type":20},"2025-01-31",{"name":41,"class":42},""]