[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636328":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":43,"armGroups":39,"interventions":44,"overallOfficials":39,"centralContacts":39,"locations":39,"responsibleParty":49,"collaborators":39,"id":51,"slug":39,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":39,"enrollmentInfo":60,"targetDuration":39,"studyType":63,"phases":39,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":74,"whyStopped":39,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak contraction velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode","5 minutes after the initiation of the SBT",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"P0.1 and EXdi","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to maximal excursion of the diaphragm, measured by subcostal ultrasound in M-mode","Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT",{"measure":19,"description":11,"timeFrame":20},"P0.1 and Peak contraction velocity","Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT",{"measure":22,"description":23,"timeFrame":20},"P0.1 and EXdi,0.1","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to excursion of the diaphragm measured 100 ms after the beginning of the inspiration, measured by subcostal ultrasound in M-mode",{"measure":25,"description":26,"timeFrame":20},"P0.1 and Velocity Time Integral","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to velocity time integral of the diaphragm, measured by subcostal ultrasound in TDI-mode",{"measure":28,"description":29,"timeFrame":20},"P0.1 and Peak relaxation velocity","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode",{"measure":31,"description":32,"timeFrame":20},"P0.1 and Peak relaxation rate","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation rate of the diaphragm, measured by subcostal ultrasound in TDI-mode",{"measure":34,"description":35,"timeFrame":20},"P0.1 and TFdi","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to thickening fraction of the diaphragm, measured by intercostal ultrasound in M-mode.",{"measure":37,"description":38,"timeFrame":20},"P0.1 and mean thickening velocity","Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to mean thickening velocity of the diaphragm, measured by intercostal ultrasound in M-mode.",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","Patients admitted to the intensive care unit who are intubated or have undergone a tracheostomy.",[45],{"type":46,"name":47,"description":48,"armGroupLabels":39,"otherNames":39},"DEVICE","Spontaneous breathing trial","A plateau pressure measurement will be performed before starting the spontaneous breathing trial (SBT). Then, immediately and 5, 10, 15, 20, 25, and 30 minutes after the start of the SBT, the following will be performed as part of the study:\n\n* Subcostal diaphragmatic ultrasound: M-mode and tissue Doppler\n* Lateral diaphragmatic ultrasound: 2D mode and M-mode\n* Measurement of P0.1\n* Measurement of Pocc during a tele-expiratory pause, only 5 minutes after the start of the SBT.",{"type":50,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100636328",false,"NCT07564258","Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function","Estimation of Airway Occlusion Pressure at 100 ms Using Ultrasound Indexes of Diaphragm Function","PoccUS","Inclusion Criteria:\n\n* \\- Age ≥ 18 years old\n* Patient intubated or tracheostomized\n* Decision by the clinician in charge to initiate a SBT\n* After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)\n\nExclusion Criteria:\n\n* \\- Suspicion of diaphragmatic nerves injury\n* Preexisting neuromuscular disease\n* Spinal cord injury above C5\n* Neuromuscular blockade within last 24 hours\n* Body mass index \\> 40 kg\u002Fm2\n* Pregnancy or breast feeding\n* Patient under legal protection","ALL","18 Years",{"count":61,"type":62},40,"ESTIMATED","OBSERVATIONAL","Occlusion pressure at 100 ms (P0.1) is a reliable and non-invasive index of inspiratory drive that can be measured easily on most ventilator. Unfortunately, P0.1 cannot be measured reliably in non-intubated patients. In those receiving non-invasive ventilation, the measurement of P0.1 might be inaccurate due to leaks. P0.1 cannot be measured at all in patients receiving high-flow nasal canulae (HFNC).\n\nUltrasound indices of diaphragm contractile function, namely diaphragm excursion, velocity and thickening fraction, could be reliable and non-invasive proxies of respiratory drive in non-intubated patient.\n\nOur hypothesis is that ultrasound indices of diaphragm function may reliably estimate P0.1. To validate this hypothesis, theses indices will be measured simultaneously with P0.1 in intubated patients, during diaphragm loading conditions similar to spontaneous breathing: the spontaneous breathing trial (SBT). The SBT is used to evaluate if patients can breathe without the assistance provided by the ventilator, and thus, be weaned from mechanical ventilation.",[66],"Acute Respiratory Disease",[68,69,70,71,72,73],"acute respiratory failure","respiratory drive","P0.1","Airway occlusion pressure","Diaphragm","ultrasonography doppler","NOT_YET_RECRUITING","2026-04-27",{"date":77,"type":78},"2026-05-04","ACTUAL",{"date":80,"type":62},"2026-07",{"date":82,"type":62},"2027-01",{"name":5,"class":6}]