[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592687":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":78,"collaborators":12,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":12,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":12,"enrollmentInfo":90,"targetDuration":12,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":56,"whyStopped":12,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Sir Run Run Shaw Hospital","OTHER",[8,13,16,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Feasibility Patient Cohort（No Intervention \u002F Diagnostic Test）","NO_INTERVENTION","Participants undergo an assessment-only diagnostic intervention: diaphragmatic speckle-tracking ultrasound performed at predefined time points during routine care to evaluate feasibility and measurement properties (e.g., foundational speckle-tracking metrics and inter-\u002Fintra-operator reproducibility). Images of the bilateral zone of apposition are acquired and analyzed offline for the contraction synchrony index, end-diaphragmatic residual contraction (EDRC), displacement velocity, and maximal displacement. Ultrasound findings are not used for clinical decision-making; respiratory support (e.g., HFNC\u002Fventilator settings) is determined independently by the treating clinicians.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Healthy Volunteer Reference Cohort","Healthy volunteers undergo protocolized, assessment-only diaphragmatic speckle-tracking ultrasound to characterize normal diaphragmatic physiology and establish reference ranges; no feasibility or reproducibility endpoints are collected. Bilateral zone-of-apposition images are acquired and analyzed offline for DPSI, contraction synchrony index, end-diaphragmatic residual contraction (EDRC), displacement velocity, and maximal displacement. No therapeutic interventions are delivered, and participation does not alter clinical management.",{"label":17,"type":18,"description":19,"interventionNames":20},"Sequence 1: 20-30-40-60 L\u002Fmin","EXPERIMENTAL","Participants receive HFNC flows 20→30→40→60 L\u002Fmin across four periods. Each period maintains the assigned flow for a predefined steady window; FiO₂ is adjusted per routine to meet target SpO₂. At the end of each period, protocolized diaphragmatic speckle-tracking ultrasound (bilateral zone of apposition) is performed with offline analysis of DPSI, contraction synchrony index, EDRC, displacement velocity, and maximal displacement; vital signs, respiratory rate, comfort\u002Ftolerance, and oxygenation are recorded. Safety overrides (e.g., hypoxemia, distress, intolerance) permit clinicians to modify or terminate the period.",[21],"Other: High-flow adjustment sequence",{"label":23,"type":18,"description":24,"interventionNames":25},"Sequence 2: 30-60-20-40 L\u002Fmin","This sequence administers HFNC flows 30→60→20→40 L\u002Fmin over four periods. Procedures mirror Sequence 1: predefined steady windows, routine FiO₂ titration, end-of-period speckle-tracking ultrasound with offline metrics (DPSI, synchrony, EDRC, displacement velocity, maximal displacement), and collection of vitals\u002Foxygenation\u002Ftolerance; safety triggers allow clinical override.",[21],{"label":27,"type":18,"description":28,"interventionNames":29},"Sequence 3: 40-20-60-30 L\u002Fmin","Participants receive HFNC flows 40→20→60→30 L\u002Fmin across four periods. A predefined steady window is maintained with routine FiO₂ adjustments. End-of-period speckle-tracking ultrasound is performed with the same offline metrics; vitals, respiratory rate, comfort\u002Ftolerance, and oxygenation are captured. Safety triggers enable clinical override.",[21],{"label":31,"type":18,"description":32,"interventionNames":33},"Sequence 4: 60-40-30-20 L\u002Fmin","HFNC flows are delivered 60→40→30→20 L\u002Fmin over four periods. Each period preserves a steady observation window with routine FiO₂ titration; end-of-period speckle-tracking ultrasound is performed with offline analyses (DPSI, synchrony, EDRC, displacement velocity, maximal displacement), and vitals\u002Foxygenation\u002Ftolerance are recorded. Safety overrides may be applied by the treating team.",[21],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":12},"High-flow adjustment sequence","Delivers heated, humidified blended oxygen via HFNC with real-time titration based on diaphragmatic speckle-tracking metrics (e.g., DPSI, contraction synchrony). Flow is adjusted in predefined increments to reach target diaphragmatic physiology while FiO₂ is titrated to maintain target SpO₂. Ultrasound feedback is used for bedside decisions; safety triggers allow clinical override.",[17,23,27,31],[40],{"name":41,"affiliation":5,"role":42},"Huiqing Ge","STUDY_CHAIR",[44,49],{"name":41,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","+86 13588706787","3588706787","gehq@zju.edu.cn",{"name":50,"role":45,"phone":51,"phoneExt":12,"email":52},"Yiqing Xu","+86 13634115344","xuyiqing@srrsh.com",[54,70],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Sir Run Run shaw Hospital Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":63,"coordinates":64},"Point",[65,66],120.16142,30.29365,{"lat":66,"lon":65},[69],{"name":41,"role":45,"phone":46,"phoneExt":12,"email":48},{"facility":71,"status":72,"city":57,"state":58,"zip":12,"country":60,"countryCode":61,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","NOT_YET_RECRUITING",{"type":63,"coordinates":74},[65,66],{"lat":66,"lon":65},[77],{"name":41,"role":45,"phone":46,"phoneExt":12,"email":48},{"type":79,"investigatorFullName":41,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Director of Respiratory Medicine","100592687","diaphragmatic-physiology-similarity-index-may-titrate-hfnc-flow-setting-a-prospective-observational-study-100592687",false,"NCT06996665","Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study","Feasibility and reproducibility：adult ICU patients\n\nMethodology for diaphragmatic motion synchrony:healthy adults and adult ICU patients Between-group comparisons and flow-titration study\n\nInclusion Criteria:\n\n1. Age ≥18 years old.\n2. Clear diagnosis of respiratory failure requiring respiratory support.\n3. Expected duration of respiratory support ≥24 hours or (high-flow\u002Fnon-invasive ventilation) ≥48 hours.\n4. Voluntary participation in this study and signed informed consent. If the participant is unable to read or sign the informed consent form due to incapacity (e.g., unconsciousness), the legal guardian must act as a proxy in the informed consent process and sign the form. If the participant cannot read the consent form (e.g., illiterate participants), a witness must observe the informed consent process and sign the form.\n\nExclusion Criteria:\n\n1. Severe chest wall deformities or diaphragmatic paralysis.\n2. End-stage disease with a predicted life expectancy of less than 24 hours.\n3. Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).\n4. Vulnerable groups other than critically ill patients\u002Felderly\u002Filliterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.",true,"ALL","18 Years",{"count":91,"type":92},100,"ESTIMATED","INTERVENTIONAL",[95],"NA","Study Objective This prospective observational study aims to investigate the role of the Diaphragmatic Physiology Similarity Index (DPSI) derived from speckle tracking ultrasound in titrating high-flow nasal cannula (HFNC) flow settings, and to evaluate its application in patients with acute respiratory failure.\n\nPrimary Research Questions\n\nTo characterize the features of the DPSI in healthy individuals and in patients with acute respiratory failure.\n\nTo assess the behavior of the DPSI under different HFNC flow settings in patients with acute respiratory failure.\n\nSecondary Research Questions\n\nFeasibility and inter-operator reproducibility of diaphragmatic speckle tracking.\n\nAssessment of the Diaphragmatic Contraction Synchrony Index.\n\nEvaluation of End-Diaphragmatic Residual Contraction (EDRC).\n\nAdditional fundamental parameters, including diaphragmatic displacement velocity and maximum displacement.",[98],"Respiratory Failure",[100,101,102],"Diaphragm","Speckle Tracking","PEEP","2026-03-22",{"date":105,"type":106},"2026-03-25","ACTUAL",{"date":108,"type":106},"2025-06-01",{"date":110,"type":92},"2026-12-02",{"name":5,"class":6},2]