[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592675":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":39,"locations":45,"responsibleParty":79,"collaborators":43,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":43,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":43,"enrollmentInfo":91,"targetDuration":43,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Invasive Ventilation (NIV)","EXPERIMENTAL","Device \\& Settings\n\nBi-level positive airway pressure (BiPAP) is set with an inspiratory positive airway pressure (IPAP) of 10-16 cmH₂O and an expiratory positive airway pressure (EPAP) of 5-8 cmH₂O.\n\nAdjust the fraction of inspired oxygen (FiO₂) to achieve an oxygen saturation (SpO₂) of ≥ 92%.",[13],"Device: Non-Invasive Ventilation (NIV)",{"label":15,"type":10,"description":16,"interventionNames":17},"High velocity nasal insufflation (HVNI)","Device \\& Settings\n\nThe high-velocity nasal cannula system delivers heated, humidified gas at flow rates of 35-60 L\u002Fmin.\n\nFiO₂ titrated to maintain SpO₂ ≥ 92 %.",[18],"Device: High Velocity Nasal Insufflation",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Bi-Level NIV delivers two preset pressure levels-Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP)-via a tightly fitting mask interface",[9],[25],"Bi-level Positive airway pressure ventilation (BIPAP)",{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"High Velocity Nasal Insufflation","High-Velocity Nasal Cannula therapy delivers heated, humidified gas at flow rates exceeding patients' peak inspiratory demands (35-60 L\u002Fmin), with precise FiO₂ control up to 100 %",[15],[31,32],"High velocity nasal cannula","Vapotherm Delivery system",[34,37],{"name":35,"affiliation":5,"role":36},"Ahmad M. Shaddad, MD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":5,"role":36},"Aliae A. Hussien, MD",[40],{"name":35,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+201111171930",null,"shaddad_ahmad@yahoo.com",[46,70],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Assuit Univeristy","RECRUITING","Asyut","Assuit","71515","Egypt","EG",{"type":55,"coordinates":56},"Point",[57,58],31.18368,27.18096,{"lat":58,"lon":57},[61,62,63,64,66,68],{"name":35,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":43,"role":41,"phone":43,"phoneExt":43,"email":44},{"name":38,"role":36,"phone":43,"phoneExt":43,"email":43},{"name":65,"role":36,"phone":43,"phoneExt":43,"email":43},"Maiada K. Hashem, MD",{"name":67,"role":36,"phone":43,"phoneExt":43,"email":43},"Ahmad M. Abd El-hafeez, MD",{"name":69,"role":36,"phone":43,"phoneExt":43,"email":43},"Amal M. Tohamy, MD",{"facility":71,"status":48,"city":49,"state":43,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt",{"type":55,"coordinates":73},[57,58],{"lat":58,"lon":57},[76],{"name":77,"role":41,"phone":42,"phoneExt":43,"email":78},"Ahmad M. shaddad, MD","shaddad_ahmad@aun.edu.eg",{"type":36,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Ahmad Shaddad","Associate Professor","100592675","noninvasive-support-for-acute-respiratory-failure-in-guillain-barr-syndrome-100592675",false,"NCT06996509","Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome","Prospective, Randomized, Controlled, Open-Label Single-Center Trial Comparing High-Velocity Nasal Insufflation (HVNI) Versus Non-Invasive Ventilation (NIV) for Acute Respiratory Failure in Guillain-Barré Syndrome","Inclusion Criteria:\n\n* Age ≥ 18 years\n* GBS per Brighton criteria (clinical ± cerebrospinal fluid (CSF)\u002Felectrodiagnostics)\n* Moderate acute respiratory failure (vital capacity (VC) 15-20 mL\u002Fkg and\u002For arterial partial pressure of carbon dioxide (PaCO₂) \\> 45 mmHg or arterial partial pressure of oxygen (PaO₂) \\\u003C 70 mmHg on room air (RA) and\u002For respiratory rate (RR) \\> 24 \u002Fmin)\n* Hughes Grade 3-4, The Erasmus Guillain-Barré Syndrome Respiratory Insufficiency Score (EGRIS) 1-3, Medical Research Council (MRC) sum score 20-40\n* Glasgow Coma Scale (GCS) ≥ 13, intact cough\u002Fgag, stable hemodynamics\n* Onset of respiratory symptoms ≤ 7 days\n\nExclusion Criteria:\n\n* Chronic respiratory disease (COPD, interstitial lung diseases (ILD), persistent asthma)\n* Immediate need for invasive ventilation (VC \\\u003C 10 mL\u002Fkg, unresponsive severe gas-exchange derangement)\n* Severe bulbar dysfunction or prior intubation for the current illness\n* Contraindications to HVNC\u002FNIV (facial trauma, untreated pneumothorax, agitation, vomiting)\n* Pregnancy\n* Severe comorbidity limiting prognosis.\n* Declined consent","ALL","18 Years",{"count":92,"type":93},80,"ESTIMATED","INTERVENTIONAL",[96],"NA","This study will involve 70 adult patients with Guillain-Barré syndrome who have severe breathing problems. It will compare two types of breathing support: high-velocity nasal cannula (HVNC) (which delivers heated and humidified air at 35-60 L\u002Fmin) and bi-level noninvasive ventilation (NIV) (which uses two pressure levels: inspiratory positive airway pressure (IPAP) 10-16 cmH₂O and expiratory positive airway pressure (EPAP) 5-8O). The main goal is to see how many patients can stop using non-invasive support without needing a breathing machine by Day 30. Other goals include how long it takes to stop using support, how comfortable patients feel, how long they stay in the ICU or hospital, how many days they can breathe on their own, and the number of deaths in 30 days. The main goal is to see how many patients can stop using non-invasive support without needing invasive ventilation by Day 30, while also looking at other factors like how long it takes to stop assistance, how comfortable patients are, how long they stay in the hospital, how many days they can breathe on their own, the number of deaths within 30 days, and their overall health.",[99],"Guillain-Barre Syndrome",[101],"GBS","2026-04-26",{"date":104,"type":105},"2026-04-30","ACTUAL",{"date":107,"type":105},"2025-08-01",{"date":109,"type":93},"2026-11-01",{"name":5,"class":6},2]