[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621124":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":46,"overallOfficials":56,"centralContacts":61,"locations":70,"responsibleParty":88,"collaborators":26,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":26,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":26,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"HFNO Failure (Endotracheal Intubation Within 72 Hours)","HFNO failure was defined as endotracheal intubation within 72 hours after HFNO initiation due to refractory hypoxemia, progressive respiratory acidosis, severe respiratory distress, or hemodynamic instability. Escalation to noninvasive ventilation (NIV) without endotracheal intubation and within-tier adjustments (increasing flow or FiO2 without changing support modality) were NOT considered the primary failure event. The model is intended for reassessment at 30 minutes, but the outcome is assessed within 72 hours.Unit of Measure:\n\nProportion of participants.","Within 72 hours after HFNO initiation.",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Model Discrimination in Retrospective Temporal Validation","Area under the receiver operating characteristic curve (AUC) of the frozen dual-domain model for predicting endotracheal intubation within 72 hours in the retrospective temporal validation cohort.Unit of Measure:\n\nAUC (dimensionless, 0-1).",{"measure":18,"description":19,"timeFrame":12},"Model Calibration in Retrospective Temporal Validation","Calibration intercept and slope of the frozen dual-domain model in the retrospective temporal validation cohort. Unit of Measure: Dimensionless.",{"measure":21,"description":22,"timeFrame":12},"Model Discrimination in Prospective Validation","AUC of the frozen dual-domain model for predicting endotracheal intubation within 72 hours in the ongoing prospective validation cohort.Unit of Measure:\n\nAUC (dimensionless, 0-1).",{"measure":24,"description":25,"timeFrame":12},"Model Calibration in Prospective Validation","Calibration intercept and slope of the frozen dual-domain model in the ongoing prospective validation cohort. Unit of Measure: Dimensionless.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":6,"maskingInfo":26},"COHORT","This was a single-center, ambispective observational cohort study conducted at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, between May 2025 and March 2026, with an ongoing prospective validation stage. Adults with AHRF receiving HFNO as initial respiratory support were included. Patients with an immediate indication for endotracheal intubation, severe hemodynamic instability, marked consciousness disturbance or inability to cooperate with monitoring, or missing\u002Finadequate EIT data were excluded. Clinical, physiological, blood gas, and EIT data were collected at baseline before HFNO and at 30 minutes after HFNO initiation. EFI was calculated from the global EIT impedance curve.\n\nStage 1 (retrospective derivation): the first 57 consecutive patients were included retrospectively; baseline EFI, baseline PaCO2, ΔRR, and ΔSpO2 were used to develop and lock a dual-domain logistic model.\n\nStage 2 (retrospective temporal validation): the later 58 patients were included retrospectively; the frozen model coefficients were directly applied without refitting. Results of Stages 1 and 2 have been reported.\n\nStage 3 (prospective validation): an independent multicenter prospective validation cohort is currently being enrolled. The same inclusion\u002Fexclusion criteria, 30-minute reassessment protocol, and frozen model will be applied without refitting.\n\nThe primary endpoint is endotracheal intubation within 72 hours after HFNO initiation.\n\nThe retrospective stages were approved by the Ethics Committee of Ruijin Hospital (Approval No. 2025232), and informed consent was waived. The prospective validation stage was approved by the same committee (Approval No. (2026592), and written informed consent is obtained from all prospectively enrolled participants.","Adult patients with acute respiratory failure receiving HFNO",[32,38,42],{"label":33,"type":26,"description":34,"interventionNames":35},"Retrospective derivation cohort","First 57 consecutive adults with AHRF receiving HFNO (May-September 2025); used to develop and lock the dual-domain model. Completed.",[36,37],"Other: High-Flow Nasal Oxygen Therapy","Device: Electrical Impedance Tomography Monitoring",{"label":39,"type":26,"description":40,"interventionNames":41},"Retrospective temporal validation cohort","Later 58 adults with AHRF receiving HFNO (October 2025-March 2026); frozen model applied without refitting. Completed.",[36,37],{"label":43,"type":26,"description":44,"interventionNames":45},"Prospective validation cohort","Independent adults with AHRF receiving HFNO; currently being prospectively enrolled at multiple centers. Frozen model applied without refitting. Ongoing.",[36,37],[47,51],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":26},"High-Flow Nasal Oxygen Therapy","Patients received HFNO as part of standard clinical care for acute hypoxemic respiratory failure. The treatment was titrated by the clinical team based on physiological parameters (SpO2, RR, ABG), aiming to maintain SpO2 ≥ 92% and reduce signs of respiratory distress.",[43,33,39],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":26},"DEVICE","Electrical Impedance Tomography Monitoring","PulmoVista 500 EIT device (Dräger Medical, Lübeck, Germany) was used for continuous real-time monitoring of regional lung ventilation and to derive the EIT-derived flow index (EFI) at baseline and 30 minutes.",[43,33,39],[57],{"name":58,"affiliation":59,"role":60},"Hongping Qu","Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine","STUDY_CHAIR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":26,"email":66},"rui zhang, Dr","CONTACT","0086-021-21666066","ccmzhangrui@foxmail.com",{"name":58,"role":64,"phone":68,"phoneExt":26,"email":69},"0086-021-67340045","qhp10516@rjh.com.cn",[71],{"facility":59,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":79,"coordinates":80},"Point",[81,82],121.45806,31.22222,{"lat":82,"lon":81},[85],{"name":86,"role":64,"phone":87,"phoneExt":26,"email":66},"Rui Zhang","02164370045",{"type":89,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100621124","predicting-high-flow-nasal-oxygen-failure-at-30-minutes-using-a-physiology-informed-dual-domain-model-100621124",false,"NCT07366541","Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes","A Physiology-Informed Dual-Domain Model for 30-Minute Reassessment to Predict Endotracheal Intubation Within 72 Hours After High-Flow Nasal Oxygen Initiation in Adults With Acute Hypoxemic Respiratory Failure: A Retrospective Derivation and Multicenter Prospective Validation Study","EFI-HFNO","Inclusion Criteria (must meet all):\n\n* Age ≥18 years\n* Acute hypoxemic respiratory failure (AHRF) requiring HFNO initiation\n* At least one of the following high-risk criteria: a) PaO₂\u002FFiO₂ ≤200 mmHg or FiO₂ ≥0.40 to maintain SpO₂ ≥92%; b) Respiratory rate ≥25\u002Fmin; c) APACHE II score ≥12; d) Bilateral infiltrates on chest imaging\n\nExclusion Criteria:\n\n* Neuromuscular disease affecting spontaneous breathing\n* Pregnancy\n* Contraindication to EIT (e.g., chest wall wounds, pacemaker)\n* Do-not-intubate order\n* Hypercapnic respiratory failure as primary diagnosis (PaCO₂ \\>50 mmHg with pH \\\u003C7.30 at baseline, unless mixed mechanism)","ALL","18 Years",{"count":101,"type":102},115,"ESTIMATED","OBSERVATIONAL","This is a single-center, ambispective observational cohort study of adults with acute hypoxemic respiratory failure (AHRF) receiving high-flow nasal oxygen (HFNO) as initial respiratory support. The study includes three stages. Stage 1 (retrospective derivation): the first 57 consecutive patients (May-September 2025) were retrospectively included to develop and lock a dual-domain logistic model using baseline EFI, baseline PaCO2, and 0-30 minute changes in respiratory rate (ΔRR) and SpO2 (ΔSpO2). Stage 2 (retrospective temporal validation): the later 58 patients (October 2025-March 2026) were retrospectively included, and the frozen model was directly applied without refitting; results of Stages 1 and 2 have been reported. Stage 3 (prospective validation): an independent prospective validation cohort is currently being enrolled, and the frozen model will be applied without refitting. The primary outcome is endotracheal intubation within 72 hours after HFNO initiation. This registration covers the complete study; the retrospective stages have been reported, and the prospective stage is ongoing.",[106,107,48],"Acute Respiratory Failure","Electrical Impedance Tomography (EIT)",[109,110,111,112,113,114],"Acute hypoxemic respiratory failure","High-flow nasal oxygen","Electrical impedance tomography","EIT-derived flow index","Prediction model","Multicenter prospective validation","2026-10-05",{"date":117,"type":118},"2026-10-08","ACTUAL",{"date":120,"type":118},"2025-05-01",{"date":122,"type":102},"2026-12-31",{"name":5,"class":6},1]