[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586920":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":44,"locations":45,"responsibleParty":68,"collaborators":44,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":44,"enrollmentInfo":82,"targetDuration":44,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Università degli Studi di Trento","OTHER",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Pressure Support PMI=0","EXPERIMENTAL","The PS level at which PMI is zeroed, meaning the patient's inspiratory effort contributes minimally to tidal volume",[13],"Procedure: Variation of Pressure Support Levels",{"label":15,"type":10,"description":16,"interventionNames":17},"Pressure Support +2","Above PSPMI=0: +2 cmH₂O above PSPMI=0 (over-assistance zone).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Pressure Support +4","Above PSPMI=0: +4 cmH₂O above PSPMI=0 (over-assistance zone).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Pressure Support +6","Above PSPMI=0: +6 cmH₂O above PSPMI=0 (over-assistance zone).",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Pressure Support -2","Below PSPMI=0: -2 cmH₂O below PSPMI=0 (under-assistance zone).",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Pressure Support -4","\\- Below PSPMI=0: -4 cmH₂O below PSPMI=0 (under-assistance zone).",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Pressure Support -6","\\- Below PSPMI=0: -6 cmH₂O below PSPMI=0 (under-assistance zone).",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Variation of Pressure Support Levels","Patients will undergo six randomized PS levels (+2, +4, +6 cmH₂O above and -2, -4, -6 cmH₂O below PSPMI=0).",[15,19,23,27,31,35,9],null,[46],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Santa Chiara Hospital, Trento, Trentino-Alto Adige, Italy","RECRUITING","Trento","38122","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],11.12108,46.06787,{"lat":57,"lon":56},[60,65],{"name":61,"role":62,"phone":63,"phoneExt":44,"email":64},"Giacomo Bellani, MD, PhD","CONTACT","+ 39 0461 903298","giacomo.bellani@unitn.it",{"name":66,"role":62,"phone":44,"phoneExt":44,"email":67},"Eleonora Balzani, MD","eleonora.balzani@unitn.it",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Centre for Medical Sciences","Professor Giacomo Bellani","100586920","targeting-pressure-muscle-index-to-avoid-ventilatory-over-assistance-during-pressure-support-ventilation-100586920",false,"NCT06921655","Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation","Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure","TEMA","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Mechanically ventilated in the ICU\n3. Diagnosis of Acute Hypoxemic Respiratory Failure (AHRF)\n4. Normocapnia or non-severe hypercapnia\n5. Receiving Pressure Support Ventilation (PSV) for at least 24-72 hours\n6. Presence of an arterial line for blood gas sampling\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Known neurological or neuromuscular disorders affecting diaphragm function\n3. Chronic Obstructive Pulmonary Disease (COPD) or hypercapnic respiratory failure\n4. Psychomotor agitation or inadequate sedation","ALL","18 Years",{"count":83,"type":84},36,"ESTIMATED","INTERVENTIONAL",[87],"NA","The TEMA study (Targeting prEssure-Muscle-index to avoid ventilatory over-Assistance during pressure support ventilation) is a prospective, interventional crossover trial investigating the relationship between pressure support (PS) and tidal volume (Vt) in ICU patients with acute hypoxemic respiratory failure (AHRF) receiving pressure support ventilation (PSV). The study aims to assess whether the Pressure-Muscle Index (PMI)-a marker derived from the difference between plateau and peak inspiratory pressure-can help identify the optimal level of ventilatory assistance, preventing over-assistance and its associated complications such as diaphragm atrophy and patient self-inflicted lung injury (P-SILI). By exploring the sigmoidal relationship between PS and Vt, the study seeks to define a physiological threshold (PMI=0) that may serve as a personalized target for PSV titration.",[90,91],"Acute Hypoxemic Respiratory Failure","Mechanical Ventilation Complication",[93,94,90],"Pressure Support","Tidal Volume","2026-06-03",{"date":97,"type":98},"2026-06-05","ACTUAL",{"date":100,"type":98},"2025-10-08",{"date":102,"type":84},"2028-12-15",{"name":70,"class":6},1]