[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608232":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":44,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"NIV Group","EXPERIMENTAL","Patients who can afford to buy or attain a Bi-PAP device will be enrolled in this interventional group long-term NIV (Bi-PAP), They will also keep taking their optimal medical therapy, with or without LTOT according to oxygen status.",[13,14],"Device: BiPAP device (non invasive ventilation)","Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","ACTIVE_COMPARATOR","Patients who cannot attain a BiPAP device are managed with their optimal medical therapy, with or without LTOT according to oxygen status",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","BiPAP device (non invasive ventilation)","BiPAP initiated 2-4 weeks post-discharge; IPAP 16 cmH₂O (titrate), EPAP 4 cmH₂O; supplemental O₂ as needed monitor SpO₂, ABG, vitals; target ≥20% PaCO₂ reduction, improved pH, reduced work of breathing; adherence ≥4 hrs\u002Fnigh\n\nScheduled monitoring of SpO₂, symptoms, and adherence; outpatient follow-up at 2-4 weeks and after 1, 3, 6 ,12 month intervals",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)","Patients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV",[16,9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Mostafa Mahmoud Ahmed","CONTACT","0201001554241","doc.mostafa5454@gmail.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mostafa Mahmoud Ahmed AbdAllah","Principal investigator","100608232","impact-of-home-non-invasive-ventilation-in-patients-with-chronic-obstructive-pulmonary-disease-discharged-from-assiut-university-hospital-100608232",false,"NCT07198880","Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital","Inclusion Criteria:\n\n* Patients more than 18 year old.\n* Severe COPD (classified as GOLD stage Ⅲ and IV), confirmed by FEV₁\u002FFVC \\\u003C 70% and FEV₁ \\\u003C 50% of the predicted value. (9)\n* Persistent hypercapnia (PaCO₂ ≥ 60 mmHg ≥2 weeks after resolution of acute exacerbation and compliant on optimal medical therapy with or without long term oxygen therapy\n\nExclusion Criteria:\n\n* Other significant respiratory disorders (e.g,history suggestive OSA, Body Mass Index more than 30, pneumothorax, bullous lung disease, advanced interstitial lung diseases , restrictive thoracic wall diseases , neuromuscular disease).\n* Undergone intubation or tracheostomy prior to NIV initiation during the last 2 months.\n* Those using addictive narcotic medications.\n* Comorbidities and diseases that might confound survival outcomes (e.g., malignancy, advanced hepatic or renal diseases).\n* Pregnancy\n* Refusal or Inability to tolerate NIV during initiation and adaptation phase.\n* Expected Poor compliance (patients deemed unlikely to adhere to nightly NIV use such as no family support, severe frailty).\n* Withdrawal criteria: stopping bipap or medical treatment, voluntary withdrawal by the participant, failure to attend scheduled visits, and significant clinical deterioration requiring alternative management during the study period","ALL","18 Years","80 Years",{"count":52,"type":53},40,"ESTIMATED","INTERVENTIONAL",[56],"NA","This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD",[59,60,61,62,63,64,65],"COPD","COPD (Chronic Obstructive Pulmonary Disease)","Ventilation Therapy","Non Invasive Ventilation (NIV)","BiPAP","Hypercapnia","Long Term Oxygen Therapy","NOT_YET_RECRUITING","2025-09-27",{"date":69,"type":70},"2025-09-30","ACTUAL",{"date":72,"type":53},"2026-01-01",{"date":74,"type":53},"2028-01-01",{"name":5,"class":6}]