[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607398":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":79,"collaborators":81,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":30,"enrollmentInfo":97,"targetDuration":30,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":118,"whyStopped":30,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low PEEP","EXPERIMENTAL","Low positive end-expiratory pressure (4 cmH2O)",[13],"Procedure: Low positive end-expiratory pressure",{"label":15,"type":10,"description":16,"interventionNames":17},"Medium PEEP","Medium positive end-expiratory pressure (10 cmH2O)",[18],"Procedure: Medium positive end-expiratory pressure",{"label":20,"type":10,"description":21,"interventionNames":22},"High PEEP","High positive end-expiratory pressure (16 cmH2O)",[23],"Procedure: High positive end-expiratory pressure",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Low positive end-expiratory pressure","Low (4 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Medium positive end-expiratory pressure","Medium (10 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"High positive end-expiratory pressure","High(16 cmH2O) positive end-expiratory pressure (PEEP) will be applied during pressure support ventilation. The PEEP level will be kept for 10 minutes prior to data acquisition.",[20],[40],{"name":41,"affiliation":42,"role":43},"Hannes Widing","Anesthesia and intensive care medicine, Område 5, Sahlgrenska University hospital, Västra Götalandsregionen","PRINCIPAL_INVESTIGATOR",[45,49],{"name":41,"role":46,"phone":47,"phoneExt":30,"email":48},"CONTACT","0046703957374","hannes.widing@vgregion.se",{"name":50,"role":46,"phone":30,"phoneExt":30,"email":51},"Per Persson","per.persson@gregion.se",[53,69],{"facility":54,"status":30,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Central intensivvårdsavdelning, Sahlgrenska University Hospital","Gothenburg","Västra Götaland County","413 45","Sweden","SE",{"type":61,"coordinates":62},"Point",[63,64],11.96679,57.70716,{"lat":64,"lon":63},[67,68],{"name":41,"role":46,"phone":47,"phoneExt":30,"email":48},{"name":41,"role":43,"phone":30,"phoneExt":30,"email":30},{"facility":70,"status":30,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Thorax intensivvårdsavdelning, Område 6, Sahlgrenska University Hospital, Västra Götalandsregionen",{"type":61,"coordinates":72},[63,64],{"lat":64,"lon":63},[75],{"name":76,"role":46,"phone":77,"phoneExt":30,"email":78},"Viktor Erbring","0046706456664","viktor.erbring@vgregion.se",{"type":80,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[82,85],{"name":83,"class":84},"Sahlgrenska University Hospital","OTHER",{"name":86,"class":84},"Göteborg University","100607398","the-impact-of-low-versus-high-positive-end-expiratory-pressure-on-diaphragm-function-ventilation-efficiency-and-lung-mechanics-100607398",false,"NCT07188038","The Impact of Low Versus High Positive End-expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics","The Impact of Low Versus High Positive End-Expiratory Pressure on Diaphragm Function, Ventilation Efficiency, and Lung Mechanics During Pressure Support Ventilation: A Randomized Interventional Crossover Study","INFLATE-ICU","Inclusion Criteria:\n\n* Mechanical ventilation with pressure support or mechanical ventilation with possibility to transition to pressure support\n* Oxygen requirement ≤ 50%\n* Pressure support ≤ 12 cmH2O\n* PEEP ≤ 12 cmH2O\n* Age ≥ 18 years\n* Adequate intravascular volume status\n\nExclusion Criteria:\n\n* Circulatory instability\n* Brain death diagnosis\u002Fbrain death evaluation\n* Norepinephrine dose \\> 0.4 µg\u002Fkg\u002Fmin\n* Muscle relaxation administered within 2 hours\n* Pregnancy\n* Contraindication to esophageal catheterization (e.g., esophageal varices)\n* Conditions with increased risk of pneumothorax (such as severe COPD (Chronic Obstructive Pulmonary Disease) or extensive emphysema)\n* Untreated pneumothorax\n* Symptomatic airway obstruction\n\nDiscontinuation criteria during ongoing study intervention:\n\n* Heart rate \\> 120 beats\u002Fmin\n* Systolic blood pressure \\> 180 mmHg\n* Inspired oxygen fraction \\> 70%\n* Respiratory rate \\> 35\u002Fmin\n* RASS (Richmond Agitation Sedation Scale) ≥ 2\n* Doubling of norepinephrine dose or increase of norepinephrine dose to \\> 0.5 µg\u002Fkg\u002Fmin to maintain mean arterial pressure\n* Bradycardia \\\u003C 45 beats\u002Fmin","ALL","18 Years",{"count":98,"type":99},25,"ESTIMATED","INTERVENTIONAL",[102],"NA","The goal of this interventional study is to evaluate the effect of different positive end-expiratory pressures (PEEP) on lung and diaphragm function in patients mechanically ventilated with pressure support ventilation in the intensive care unit. The main questions aim to answer:\n\nDoes higher PEEP level affect diaphragm contractions and ventilatory efficiency? Does higher PEEP level limit inspiratory efforts? Does higher PEEP level affect lung compliance?\n\nThe participants will be subjected to three different PEEP levels during pressure support ventilation:\n\nLow PEEP (4 cmH2O), Medium PEEP (10 cmH2O), High PEEP (16 cmH2O).\n\nThe lung and diaphragm function will be evaluated using high-resolution esophageal manometry, electrical activity of the diaphragm, external diaphragm ultrasound and spirometric ventilator data.",[105,106,107,108],"Respiratory Failure","ARDS (Acute Respiratory Distress Syndrome)","Pneumonia","Respiratory Insufficiency",[110,111,112,113,114,115,116,117],"Positive end-expiratory pressure","PEEP","pressure support ventilation","assisted breathing","Inspiratory effort","Inspiratory drive","Ventilation efficiency","Diaphragm","NOT_YET_RECRUITING","2025-09-15",{"date":121,"type":122},"2025-09-23","ACTUAL",{"date":124,"type":99},"2025-10-01",{"date":126,"type":99},"2027-12-31",{"name":5,"class":6},2]