[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657768":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":16,"studyPopulation":16,"armGroups":30,"interventions":43,"overallOfficials":16,"centralContacts":53,"locations":59,"responsibleParty":105,"collaborators":16,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":16,"enrollmentInfo":117,"targetDuration":16,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":130,"overallStatus":62,"whyStopped":16,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Hôpital Universitaire Taher Sfar","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Total duration of mechanical ventilation","Total cumulative duration of mechanical ventilation, defined as the sum of the duration of non-invasive ventilation and invasive mechanical ventilation.","From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Mortality at Day 28",null,"Day 28 after randomization",{"measure":19,"description":16,"timeFrame":20},"Length of stay in the intensive care unit","From randomization until ICU discharge or death, up to 28 days",{"measure":22,"description":16,"timeFrame":23},"Requirement for invasive mechanical ventilation","From randomization until ICU discharge or death",{"allocation":25,"interventionModel":26,"interventionModelDescription":16,"primaryPurpose":27,"observationalModel":16,"timePerspective":16,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":16,"whoMasked":16},"NONE",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Controlled oxygen therapy group","EXPERIMENTAL","Controlled oxygen therapy group: Oxygen will be administered using an adjustable delivery device (nasal cannula, Venturi mask, or heated high-flow humidified oxygen) to maintain an Sp-92% oxygen saturation (SpO-92%).",[36],"Other: Controlled oxygen therapy",{"label":38,"type":39,"description":40,"interventionNames":41},"Standard oxygen therapy group:","ACTIVE_COMPARATOR","Standard oxygen therapy group: Oxygen will be administered according to the unit's usual practice, targeting an SpO₂ \\>94%.",[42],"Other: Standard oxygen therapy",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":16},"OTHER","Controlled oxygen therapy","Oxygen therapy will be administered using an adjustable oxygen delivery device, including nasal cannula, Venturi mask, or high-flow nasal oxygen, and titrated to maintain peripheral oxygen saturation (SpO₂) between 88% and 92%.",[32],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":16},"Standard oxygen therapy","Oxygen therapy will be administered according to the usual practice of the intensive care unit and adjusted to maintain peripheral oxygen saturation (SpO₂) above 94%.",[38],[54],{"name":55,"role":56,"phone":57,"phoneExt":16,"email":58},"Hajer Nouira","CONTACT","+21622858699","nouirahajer@gmail.com",[60,86],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Taher Sfar Mahdia Hospital","RECRUITING","Mahdia","Mahdia Governorate","5100","Tunisia","TN",{"type":69,"coordinates":70},"Point",[71,72],11.06222,35.50472,{"lat":72,"lon":71},[75,79,81,84],{"name":76,"role":56,"phone":77,"phoneExt":16,"email":78},"Mohamed Fekih Hassen, Professor","+21622987642","mohamed.fekihhassen1@gmail.com",{"name":80,"role":56,"phone":57,"phoneExt":16,"email":58},"Hajer Nouira, Associate professor",{"name":82,"role":83,"phone":16,"phoneExt":16,"email":16},"Mohamed Fekih Hassen, Professor of Medical Intensive","PRINCIPAL_INVESTIGATOR",{"name":85,"role":83,"phone":16,"phoneExt":16,"email":16},"Hajer Nouira, Associate Professor",{"facility":87,"status":88,"city":89,"state":16,"zip":16,"country":66,"countryCode":67,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Dhouha Ben Braiek","NOT_YET_RECRUITING","Kairouan",{"type":69,"coordinates":91},[92,93],10.09633,35.6781,{"lat":93,"lon":92},[96,100,103],{"name":97,"role":56,"phone":98,"phoneExt":16,"email":99},"Dhouha Ben Braiek, Assistant Professor of Medical","+21650523823","bbraiek.dhouha@gmail.com",{"name":101,"role":102,"phone":16,"phoneExt":16,"email":16},"Dhouha Ben Braiek, Assistant Professor","SUB_INVESTIGATOR",{"name":104,"role":102,"phone":16,"phoneExt":16,"email":16},"Sourour Bel Haj Youssef, Assistant professor",{"type":83,"investigatorFullName":55,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Associate Professor of Intensive Care Medicine","100657768","controlled-versus-standard-oxygen-therapy-in-icu-patients-with-acute-exacerbation-of-copd-100657768",false,"NCT07842510","Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD","Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial","OXYCOPD-ICU","Inclusion Criteria:\n\n* Age ≥ 40 years\n* Established diagnosis of chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria\n* Admission to the intensive care unit for an acute exacerbation of COPD, with or without respiratory acidosis\n* Written informed consent provided by the participant or their legally authorized representative\n\nExclusion Criteria:\n\n* Endotracheal intubation performed before enrollment\n* Severe decompensated heart failure with a left ventricular ejection fraction \\\u003C 30%\n* Active terminal malignancy\n* Refusal to participate in the study","ALL","40 Years",{"count":118,"type":119},240,"ESTIMATED","INTERVENTIONAL",[122],"NA","Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Acute exacerbations frequently require intensive care unit (ICU) admission. Oxygen therapy is an essential component of treatment; however, excessive oxygen administration may aggravate hypercapnia and respiratory acidosis. Current international guidelines recommend titrated oxygen therapy targeting an oxygen saturation of 88-92% in patients with acute exacerbation of COPD, but evidence supporting this strategy in critically ill ICU patients remains limited. This randomized controlled trial aims to compare a controlled oxygen therapy strategy (target oxygen saturation 88-92%) with standard oxygen therapy (oxygen saturation \\>94%) in ICU patients admitted with acute exacerbation of COPD. The primary objective is to determine whether controlled oxygen therapy reduces the duration of mechanical ventilation (invasive and non-invasive). Secondary objectives include assessing the 28-day mortality, ICU length of stay, the need for invasive mechanical ventilation, and adverse events related to hyperoxia.",[125,126,127,128,129],"Chronic Obstructive Pulmonary Disease (COPD)","Acute Exacerbation of COPD","Intensive Care Unit (ICU)","Controlled Oxygen Therapy","Mechanical Ventilation Complication",[131],"COPD; Acute exacerbation; Controlled oxygen therapy; Mechanical ventilation; Intensive care unit.","2026-09-21",{"date":134,"type":135},"2026-09-25","ACTUAL",{"date":137,"type":135},"2026-01-01",{"date":139,"type":119},"2028-12-31",{"name":5,"class":6},2]