[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493343":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":60,"collaborators":40,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":40,"enrollmentInfo":71,"targetDuration":40,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Central Denmark Region","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Titrated Oxygen","EXPERIMENTAL","If the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l\u002Fmin. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures).\n\nFollowing scenarios regarding SpO2 can occur during treatment:\n\nSpO2 \\\u003C88%: Supplemental oxygen via the EtCO2-meter up to 10 l\u002Fmin, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter.\n\nSpO2 88-92%: No intervention.\n\nSpO2 \\>92%: No intervention.\n\nIf repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.",[13],"Drug: Titrated Oxygen",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Oxygen","ACTIVE_COMPARATOR","If the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l\u002Fmin. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP.\n\nFollowing scenarios regarding SpO2 can occur during treatment:\n\nSpO2 \\\u003C88%: Supplemental oxygen via the EtCO2 -meter up to 10 l\u002Fmin.\n\nSpO2 88-92%: No intervention.\n\nSpO2 \\>92%: No intervention.\n\nIf repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP.",[19],"Drug: Standard Oxygen",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%",[9],[26],"Oxygen titration to SpO₂ 88-92% and compressed atmospheric air as nebulizer driver",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators",[15],[31],"No SpO₂ target restriction and 100% compressed oxygen as nebulizer driver",[33],{"name":34,"affiliation":5,"role":35},"Martin F Gude, PhD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","0045 25343621",null,"martgude@rm.dk",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Arne Sylvester R Jensen","22396968","arjens@rm.dk",[47],{"facility":48,"status":49,"city":50,"state":40,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":40},"Prehospital Emergency Medical Servises, Central Denmark Region","RECRUITING","Aarhus N","8200","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],10.17317,56.20367,{"lat":58,"lon":57},{"type":61,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100493343","phase-4-standard-vs-targeted-oxygen-therapy-prehospital-for-chronic-obstructive-pulmonary-disease-100493343",false,"NCT05703919","Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease","STOP-COPD","Inclusion Criteria:\n\n* Patients over the age of 40\n* EMT or Paramedic suspected AECOPD\n* Confirmed suspicion of COPD\n\nExclusion Criteria:\n\n* Bronchospasm due to asthma, allergic reaction or non-COPD conditions\n* Known or suspected pregnancy\n* Prehospital Non-invasive, invasive or assisted bag mask ventilation\n* Allergy to inhaled bronchodilators (Salbutamol)\n* Inter-hospital transfer\n* More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS (emergency medical service) personnel, before allocated treatment is initiated\n* Suspicion of acute coronary syndrome","ALL","40 Years",{"count":72,"type":73},1888,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The STOP-COPD trial is a randomized, patient-blinded, prehospital clinical trial designed to evaluate the effect of titrated oxygen therapy compared to standard oxygen treatment in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The primary objective is to determine whether a titrated oxygen strategy targeting SpO₂ 88-92% can reduce 30-day mortality compared to the current standard practice using 100% compressed oxygen as a nebulizer driver.",[79,80],"COPD Exacerbation","COPD Exacerbation Acute",[9,79,82,83],"Prehospital","COPD","2025-06-08",{"date":86,"type":87},"2025-06-10","ACTUAL",{"date":89,"type":87},"2025-06-02",{"date":91,"type":73},"2028-05-31",{"name":5,"class":6},1]