[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554053":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":7,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":7,"enrollmentInfo":56,"targetDuration":7,"studyType":59,"phases":7,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",null,[9,12],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Measuring Respiratory Mechanics","First, for each patient enrolled we will perform inspiratory and expiratory occlusions - routinely performed diagnostic maneuvers to measure patient's breathing effort - at the clinically set level of breathing assistance by the mechanical ventilator. Importantly, we will measure pressure-muscle-index (PMI).\n\nSecond, we will set the level of assistance (i.e. pressure support, PS) in order to make PMI=0. The PS level at which PMI=0 (PS PMI=0) will be used as reference for the study protocol. After 5 minutes at PS PMI=0 we will perform inspiratory and expiratory occlusions.",{"type":6,"name":13,"description":14,"armGroupLabels":7,"otherNames":7},"Randomized Pressure Support","3 steps of PS above (+2, +4, +6 cmH2O) and 3 below (-2, -4, -6 cmH2O) PSPMI=0 done in a randomized order (sequence in envelopes opened blindly by the investigators). Each step will last ≤5 minutes if poorly tolerated (see tolerance rule in description). At the end of each step we will perform 1 inspiratory occlusion and 3 expiratory occlusions. Each of the expiratory occlusion will be separated by 30 seconds in order to restore the patient's breathing pattern. We will resume a 3-minutes clinical PS in between each step to minimize changes in PaCO2. If not yet comprised by the study steps each patient will undergo an adjunctive 5 minutes step at PS 0 (zero) cmH2O.",[16],{"name":17,"affiliation":18,"role":19},"Laurent Brochard","Unity Health Toronto - St. Michael's Hospital","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Laurent Brochard, MD, PhD","CONTACT","4168645686","laurent.brochard@unityhealth.to",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"St. Michael's Hospital","RECRUITING","Toronto","Ontario","M5B 1W8","Canada","CA",{"type":36,"coordinates":37},"Point",[38,39],-79.39864,43.70643,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":7,"phoneExt":7,"email":25},"Laurent Brochard, MD",{"type":45,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100554053","pressure-muscle-index-and-threshold-of-over-assistance-during-pressure-support-ventilation-100554053",false,"NCT06494085","Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation","PressUre-Muscle-index to Identify Patient's Desired Tidal Volume and the Threshold of Over-Assistance During Pressure Support Ventilation","PUMA","Inclusion Criteria:\n\n* \\>18 y.o.\n* Invasively ventilated in Intensive Care Unit.\n* Diagnosed with acute hypoxemic respiratory failure (P\u002FF\\\u003C300 mmHg).\n* Breathing on pressure support ventilation.\n\nExclusion Criteria:\n\n* \\\u003C18 y.o.\n* Contraindication for Electrical Impedence Tomography monitoring (e.g. pacemaker, burns, or - wounds limiting electrode placement).\n* Severe and previously diagnosed neurological and neuromuscular disease.\n* Psychomotor agitation (Sedation Agitation Scale \\> 4).","ALL","18 Years",{"count":57,"type":58},20,"ESTIMATED","OBSERVATIONAL","Pressure support ventilation (PSV) is used to assist the breathing of the intubated patient with some pressure from the ventilator. This support aims at avoiding excessive inspiratory effort, while ensuring a certain degree of training of the patient's inspiratory muscle. Avoiding both minimal and excessive assistance is thus important for the optimal care of the intubated patient ensuring a lung and diaphragm protective ventilation with the goal to liberate the patient from the ventilator as soon as possible.\n\nRecently pressure-muscle-index (PMI), an index of inspiratory effort easy to be measured on the ventilator screen, has been proposed to avoid excessive assistance in PSV. This will be the first prospective study testing the effects of setting pressure support based on PMI to avoid excessive assistance on patients recovering from acute lung injury (acute hypoxemic respiratory failure).",[62],"Acute Hypoxemic Respiratory Failure",[64,65,66,67],"Mechanical Ventilation","Intensive Care Unit","Pendelluft","Pressure Support Ventilation","2025-05-15",{"date":70,"type":71},"2025-05-20","ACTUAL",{"date":73,"type":71},"2024-10-04",{"date":75,"type":58},"2026-02-28",{"name":5,"class":6},1]