[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599229":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":54,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OptiNIV","EXPERIMENTAL","Patients will undergo treatment with the OptiNIV Mask",[13],"Device: OptiNIV",{"label":15,"type":16,"description":17,"interventionNames":18},"Visairo","ACTIVE_COMPARATOR","Patients will undergo treatment with Visairo Mask",[19],"Device: Visairo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Patients assigned to the \"OptiNIV\" group will be submitted to two consecutive 60-minute sessions. In the first session, they will receive NIV with an \"optimized\" mask (OptiNIV) and in the second session they will receive NIV with a traditional\" oronasal mask (Visairo). The study will follow a crossover design, meaning each patient will undergo both sessions, In both sessions, NIV will be delivered using the same ventilator (ASTRAL 150 - ResMed Europe). Ventilator settings will be set to ensure the most effective ventilation and the best comfort for each patient. However, these settings must remain unchanged during the two sessions. A 30-minute washout period is planned between the sessions, during which patients will receive traditional oxygen therapy through a Venturi mask. The 30 min wash-out periodod can be extended until PtCO₂ returns within ±2 mmHg of baseline or until 60 minutes have passed. The maximum total treatment time for each patient will be approximately 3 hours.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients assigned to the \"Visairo\" group will be submitted to two consecutive 60-minute sessions. In the first session, they will receive NIV with a \"traditional\" oronasal mask (Visairo) and in the second session they will receive NIV with an \"optimized\" mask (OptiNIV). The study will follow a crossover design, meaning each patient will undergo both sessions. In both sessions, NIV will be delivered using the same ventilator (ASTRAL 150 - ResMed Europe). Ventilator settings will be set to ensure the most effective ventilation and the best comfort for each patient. However, these settings must remain unchanged during the two sessions. A 30-minute washout period is planned between the sessions, during which patients will receive traditional oxygen therapy through a Venturi mask. The 30 min wash-out periodod can be extended until PtCO₂ returns within ±2 mmHg of baseline or until 60 minutes have passed. The maximum total treatment time for each patient will be approximately 3 hours.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Lara Pisani, MD","CONTACT","+39 0512143257","lara.pisani@unibo.it",[36],{"facility":37,"status":25,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"U.O Pneumologia e Terapia Intensiva Respiratora, IRCCS AOU di Bologna","Bologna","40138","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],11.33875,44.49381,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","dr. Stefano Nava","Prof.",[55,57],{"name":56,"class":6},"University of Bologna",{"name":58,"class":59},"Fisher and Paykel Healthcare","INDUSTRY","100599229","evaluation-of-the-effects-on-carbon-dioxide-paco2-of-a-new-oronasal-mask-in-patients-with-severe-copd-exacerbation-requiring-non-invasive-mechanical-ventilation-100599229",false,"NCT07081776","Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation","Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe Exacerbation of COPD Requiring Non-Invasive Mechanical Ventilation: A Single-Center, Exploratory, Randomized Cross-Over Study","OPTIMUS-MASK","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Informed consent obtained\n* Patients with COPD and acute hypoxemic-hypercapnic respiratory failure (pH \\\u003C 7.35, PaO₂ \\\u003C 60 mmHg, PaCO₂ \\> 45 mmHg) requiring non-invasive mechanical ventilation.\n\nExclusion Criteria:\n\n* BMI ≥ 30 kg\u002Fm²\n* Obstructive sleep apnea syndrome\n* Neuromuscular diseases or chest wall pathologies\n* Need for intubation and invasive mechanical ventilation during exacerbation\n* Use of home non-invasive mechanical ventilation or CPAP\n* Contraindications for NIV\n* Cognitive disorders that may interfere with adherence to treatments\n* Patients with active and unstable coronary artery disease\n* Previous esophageal surgery, known esophageal stenosis, or any other condition that could put the patient at risk during the placement of the respiratory mechanics probe","ALL","18 Years",{"count":71,"type":72},21,"ESTIMATED","INTERVENTIONAL",[75],"NA","This single-center, crossover study aims to investigate the effects of the new OptiNIV oronasal mask used during NIV in COPD patients with respiratory acidosis following an exacerbation. The goal is to evaluate whether the clinical benefits, in terms of reducing PaCO2 levels, are greater with the new mask compared to a traditional one (Visairo Mask).",[78,79],"COPD","Respiratory Acidosis",[78,81,82,83],"NIV","Oronasal Mask","PaCO2","NOT_YET_RECRUITING","2025-07-21",{"date":87,"type":88},"2025-07-23","ACTUAL",{"date":90,"type":72},"2025-08",{"date":92,"type":72},"2027-06",{"name":5,"class":6},1]