[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490828":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":55,"collaborators":13,"id":59,"slug":13,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":13,"enrollmentInfo":68,"targetDuration":13,"studyType":71,"phases":13,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":13,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Isala","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.","Correlation between:\n\n* Change in Borg score for dyspnea; defined as score at discharge minus score at admission\n* Change in sonographic parameters; defined as score at discharge minus score at admission","from admission till hospital discharge (expected median of 5 days based on experience)",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design.\n\nAfter inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires.\n\nFurther diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician.\n\nBoth ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.","Our population consists of 18-years or older patients who are hospitalised primarily due to AECOPD without respiratory acidosis.",[20],{"type":21,"name":22,"description":23,"armGroupLabels":13,"otherNames":13},"DIAGNOSTIC_TEST","Ultrasound of the diaphragm","Sonographic parameters of the diaphragm:\n\n* Thickening Fraction (TF); (Diaphragm thickness end-inspiration- Diaphragm thickness end-expiration) \u002F Diaphragm thickness end-expiration. (continuous variable).\n* Diaphragm end-expiratory thickness: Diaphragm thickness at end-expiration (continuous variable)\n* Diaphragm excursion (DE): diaphragm inspiratory amplitude during deep breathing (continuous variable).",[25],{"name":26,"affiliation":27,"role":28},"Marieke Duiverman, M.D. PhD.","University Medical Center Groningen","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":13,"email":34},"wytze s de Boer, m.d.","CONTACT","00316463120231","w.s.de.boer@isala.nl",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Isala Klinieken","RECRUITING","Zwolle","Overijssel","8025AB","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],6.09444,52.5125,{"lat":48,"lon":47},[51,54],{"name":52,"role":32,"phone":53,"phoneExt":13,"email":34},"Wytze de Boer, MD","+31646312031",{"name":52,"role":32,"phone":13,"phoneExt":13,"email":13},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Wytze de Boer","Coördinating Investigator","100490828",false,"NCT05671198","Sonographic Diaphragm Function in AECOPD","Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease","UNDATED","Inclusion Criteria:\n\n* Hospitalisation primarily because of severe acute exacerbation of COPD\n* COPD, according to GOLD 2018 definition\n* Post-bronchodilator FEV1\u002FFVC \\\u003C 0,70 and FEV1% \\\u003C 80%pred. within last 5 years\n\nExclusion Criteria:\n\n* Respiratory acidosis (pH \\\u003C 7.35 ánd PaCO2 \\> 6 kPA)\n* Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation.\n* Established diagnosis of diaphragm diaphragm paralysis.\n* Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).\n* Those not able or unwilling to give written informed consent.\n* Pregnant women","ALL","18 Years",{"count":69,"type":70},51,"ESTIMATED","OBSERVATIONAL","The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.",[74],"Copd",[76,77,78],"diaphragm","COPD","thoracic ultrasound","2024-10-02",{"date":81,"type":82},"2024-10-04","ACTUAL",{"date":84,"type":82},"2023-03-27",{"date":86,"type":70},"2025-08",{"name":5,"class":6},1]