[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522553":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":86,"collaborators":88,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":25,"enrollmentInfo":106,"targetDuration":25,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":25,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Franciscus Gasthuis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High Flow Nasal Oxygen (HFNO)","EXPERIMENTAL","Patients will start at a flow of 50 L\u002Fmin and a temperature of 37°C, FiO2¬ will start at 25%, and titrated to target SpO2 (88-92%, as in usual care).",[13],"Other: HFNO",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-Invasive Ventilation (NIV)","ACTIVE_COMPARATOR","Patients will be started at\n\n* Using the facemask interface: EPAP\u002FPEEP set at 5-7 cmH2O and PS of 5-7 cmH2O (equal to IPAP of 10-14 cmH2O).\n* Using the helmet interface; EPAP\u002FPEEP set at least 10 cmH2O and PS of 10 cmH2O (equal to IPAP of 20 cmH2O).\n* PEEP\u002FEPAP and IPAP\u002FPS can be titrated to effectiveness, tolerance and comfort\n* FiO2 should be set to achieve a SpO2 of 88-92%",[19],"Other: NIV",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"HFNO","Respiratory support with HFNO (as opposed to NIV, as per standard of care)",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"NIV","Respiratory support with Non-invasive ventilation, standard of care",[15],[31],{"name":32,"affiliation":33,"role":34},"Dorien Kiers, MD, PhD","Franciscus Gasthuis & Vlietland","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+3110 461 6161","d.kiers@franciscus.nl",[41,56,67,75],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Reinier de Graaf","NOT_YET_RECRUITING","Delft","Netherlands","NL",{"type":48,"coordinates":49},"Point",[50,51],4.35556,52.00667,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":25,"phoneExt":25,"email":25},"Louise Urlings, MD, PhD",{"facility":33,"status":57,"city":58,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"RECRUITING","Rotterdam",{"type":48,"coordinates":60},[61,62],4.47917,51.9225,{"lat":62,"lon":61},[65],{"name":66,"role":37,"phone":25,"phoneExt":25,"email":25},"Doiren Kiers, MD, PhD",{"facility":68,"status":43,"city":58,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Ikazia",{"type":48,"coordinates":70},[61,62],{"lat":62,"lon":61},[73],{"name":74,"role":37,"phone":25,"phoneExt":25,"email":25},"Susanne Stads, MD, PhD",{"facility":76,"status":43,"city":77,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Haaglanden Medisch Centrum","The Hague",{"type":48,"coordinates":79},[80,81],4.29861,52.07667,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":25,"phoneExt":25,"email":25},"Peter van Vliet, MD, PhD",{"type":87,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[89,91,94],{"name":90,"class":6},"Reinier de Graaf Groep",{"name":92,"class":93},"Haga Medisch Centrum","UNKNOWN",{"name":95,"class":6},"Ikazia Hospital, Rotterdam","100522553","high-flow-nasal-oxygen-for-exacerbation-copd-100522553",false,"NCT06084117","High Flow Nasal Oxygen for Exacerbation COPD","High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease","HiCAP","Inclusion Criteria:\n\n* Known chronic obstructive pulmonary disease\n* Acute hypercapnic exacerbation of this condition, defined as: PaCO2\\>45 mmHg or \\>6.0 kPa and pH 7.20-7.35\n* Age \\>40 years\n\nExclusion Criteria:\n\n* Asthma\n* Immediate need for intubation, based on clinical judgement of the attending physician.\n* Impossibility to apply either one of the two interventions\n* Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation).\n* Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome).\n* Impeding death\n* Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion.\n* Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication\n* Tracheostomized patients\n* Participation in other interventional trials\n* Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care \u002F high dependency unit, depending on local infrastructure).\n* Previous explicit (or written) objection to participation in research - bicarbonate \\\u003C20 mmol\u002FL","ALL","40 Years",{"count":107,"type":108},40,"ESTIMATED","INTERVENTIONAL",[111],"NA","In this pilot study the feasibility of performing a larger trial to study the non-inferiority of High Flow Nasal Oxygen compared to non-invasive ventilation in patients with acute acidotic hypercapnic exacerbation of COPD wil be investigated",[114],"Acute Exacerbation of COPD","2025-08-20",{"date":117,"type":118},"2025-08-21","ACTUAL",{"date":120,"type":118},"2024-05-14",{"date":122,"type":108},"2026-12-01",{"name":5,"class":6},4]