[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659335":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":41,"armGroups":45,"interventions":55,"overallOfficials":41,"centralContacts":65,"locations":41,"responsibleParty":71,"collaborators":41,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":41,"enrollmentInfo":85,"targetDuration":41,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":100,"whyStopped":41,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":41},{"fullName":5,"class":6},"Argentinian Intensive Care Society","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in end-expiratory lung impedance (EELI) during spontaneous breathing trial","Change in global end-expiratory lung impedance (ΔEELI; arbitrary units), measured by electrical impedance tomography (EIT), expressed as tidal variation of the first stable respiratory cycle, among four conditions in intubated adult patients during a spontaneous breathing trial: T-piece, high-flow tracheal oxygen (HFTO) at 50 L\u002Fmin, HFTO at 70 L\u002Fmin, and pressure support ventilation (PSV) 7 cmH₂O \u002F PEEP 0 cmH₂O. Because this is a randomized crossover study, the primary comparison is within-subject across conditions.","Baseline (t0, T-piece); after 15 minutes of HFTO 50 L\u002Fmin; after 15 minutes of HFTO 70 L\u002Fmin; after 15 minutes of PSV 7 cmH₂O\u002FPEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Change in esophageal pressure swing","Change in esophageal pressure swing (ΔPes; units cmH2O) across conditions (T-piece, HFTO 50 L\u002Fmin, HFTO 70 L\u002Fmin, PSV 7 cmH₂O \u002F PEEP 0 cmH₂O).",{"measure":18,"description":19,"timeFrame":20},"Change in Diaphragmatic Thickening Fraction (DTF)","Change in diaphragmatic thickening fraction (DTF; Units percentage) measured by ultrasonography, calculated as:\n\nDTF = \\[(thickness at end-inspiration - thickness at end-expiration) \u002F thickness at end-expiration\\] × 100.","Baseline (t0, T-piece); at the end of 15 minutes of HFTO 50 L\u002Fmin; at the end of 15 minutes of HFTO 70 L\u002Fmin; at the end of 15 minutes of PSV 7 cmH₂O\u002FPEEP 0 cmH₂O; with 15 minutes T-piece washout periods between conditions.",{"measure":22,"description":23,"timeFrame":24},"Respiratory rate","Number of ventilatory cicles per minute","Baseline (t0, T-piece); after 15 minutes of HFTO 50 L\u002Fmin; after 15 minutes of HFTO 70 L\u002Fmin; after 15 minutes of PSV 7 cmH₂O\u002FPEEP 0 cmH₂O; with T-piece washout periods between conditions.",[26,30,34],{"measure":27,"description":28,"timeFrame":29},"Days of invasive mechanical ventilation to weaning","Days of invasive mechanical ventilation from the intubation to the first weaning attempt","Baseline",{"measure":31,"description":32,"timeFrame":33},"ICU length of stay","Duration of stay in the intensive care unit (ICU) from ICU admission to ICU discharge or death, whichever occurs first (Units; days)","From ICU admission through ICU discharge or death, assessed up to [28 days] after enrollment\u002Frandomization.",{"measure":35,"description":36,"timeFrame":37},"ICU mortality","Number of participants who died in the ICU.","Through ICU discharge or up to [28 days] after enrollment\u002Frandomization.",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":41,"timePerspective":41,"maskingInfo":43},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":44,"maskingDescription":41,"whoMasked":41},"NONE",[46,51],{"label":47,"type":48,"description":41,"interventionNames":49},"Sequence A (HFTO 50 → HFTO 70)","EXPERIMENTAL",[50],"Device: T-piece, HFTO 50, washout, HFTO 70, washout, PSV.",{"label":52,"type":48,"description":41,"interventionNames":53},"Sequence B (HFTO 70 → HFTO 50)",[54],"Device: T-piece, HFTO 70, washout, HFTO 50, washout, PSV.",[56,61],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":41},"DEVICE","T-piece, HFTO 50, washout, HFTO 70, washout, PSV.","Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT):\n\nT-piece (baseline) - 15 minutes\n\nHigh-flow tracheal oxygen (HFTO) at 50 L\u002Fmin - 15 minutes\n\nWashout on T-piece - 15 minutes\n\nHFTO at 70 L\u002Fmin - 15 minutes\n\nWashout on T-piece - 15 minutes\n\nPressure support ventilation (PSV) 7 cmH₂O \u002F PEEP 0 cmH₂O - 15 minutes\n\nThroughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization.",[47],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":41},"T-piece, HFTO 70, washout, HFTO 50, washout, PSV.","Participants randomized to this Sequence receive the following conditions during a spontaneous breathing trial (SBT):\n\nT-piece (baseline) - 15 minutes\n\nHigh-flow tracheal oxygen (HFTO) at 70 L\u002Fmin - 15 minutes\n\nWashout on T-piece - 15 minutes\n\nHFTO at 50 L\u002Fmin - 15 minutes\n\nWashout on T-piece - 15 minutes\n\nPressure support ventilation (PSV) 7 cmH₂O \u002F PEEP 0 cmH₂O - 15 minutes\n\nThroughout the sequence, end-expiratory lung impedance (EELI), work of breathing (esophageal pressure-derived parameters: ΔPes, PTPes, PTPes-min), respiratory rate, SpO₂, hemodynamic variables, dyspnea, and diaphragmatic thickening fraction (DTF) are measured. This is one of two randomized crossover sequences; all participants receive all conditions in the order assigned by randomization.",[52],[66],{"name":67,"role":68,"phone":69,"phoneExt":41,"email":70},"Gustavo A Plotnikow, IP","CONTACT","5491164543771","gplotnikow@gmail.com",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Gustavo Plotnikow","Head of Physical and Respiratory Care Department, ICU","100659335","high-flow-tracheal-oxygen-during-spontaneous-breathing-trial-100659335",false,"NCT07864415","High-Flow Tracheal Oxygen During Spontaneous Breathing Trial","Effect of High-flow Tracheal Oxygen on End-expiratory Lung Impedance and Work of Breathing in Intubated Patients During a Spontaneous Breathing Trial.","HFTO-SBT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Invasive mechanical ventilation ≥ 24 hours\n* Presence of esophageal balloon catheter\n* Meets criteria to start an SBT\n* Signed informed consent by patient or responsible family member\n\nExclusion Criteria:\n\n* Neuromuscular or neurodegenerative disease\n* contraindication to electrical impedance tomography (e.g., implantable defibrillator)\n* Impossible to place EIT electrode belt (e.g., wound dressings or chest drains)\n\nElimination Criteria:\n\n* Flow intolerance\n* Behavioral\u002Fcognitive alterations that interrupt measurements in two consecutive attempts.","ALL","18 Years",{"count":86,"type":87},30,"ESTIMATED","INTERVENTIONAL",[90],"NA","The purpose of this study is to find out whether high-flow tracheal oxygen (HFTO) delivered at flows greater than 60 L\u002Fmin can increase end-expiratory lung volume (EELV) in intubated patients during a spontaneous breathing trial (SBT).\n\nWeaning from mechanical ventilation can be difficult, especially in patients at higher risk of failure. During an SBT, losing positive end-expiratory pressure (PEEP) can cause the lungs to lose volume and make breathing harder by increasing the work of breathing (WOB). HFTO may help reduce the work of breathing, but previous studies using flows of 30-60 L\u002Fmin did not consistently show an increase in EELV. Higher flows may create more airway pressure.\n\nTherefore, the main question this study is trying to answer is: In intubated patients during an SBT, does HFTO at flows greater than 60 L\u002Fmin increase EELV? The hypothesis is that HFTO at flows above 60 L\u002Fmin will increase EELV during the SBT.",[93,94,95],"Mechanical Ventilation Weaning","Spontaneous Breathing Trial","High Flow Oxygen Therapy",[97,98,94,99,95],"Mechanical Ventilation","Weaning","High Flow Tracheal Oxygen","NOT_YET_RECRUITING","2026-10-02",{"date":103,"type":104},"2026-10-07","ACTUAL",{"date":106,"type":87},"2026-10-01",{"date":108,"type":87},"2027-03-31",{"name":5,"class":6}]