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Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

RecruitingNAAges 18 Years - anyAllAssiut University
NCT06996509 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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/min) 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * GBS per Brighton criteria (clinical ± cerebrospinal fluid (CSF)/electrodiagnostics) * Moderate acute respiratory failure (vital capacity (VC) 15-20 mL/kg and/or arterial partial pressure of carbon dioxide (PaCO₂) \> 45 mmHg or arterial partial pressure of oxygen (PaO₂) \< 70 mmHg on room air (RA) and/or respiratory rate (RR) \> 24 /min) * Hughes Grade 3-4, The Erasmus Guillain-Barré Syndrome Respiratory Insufficiency Score (EGRIS) 1-3, Medical Research Council (MRC) sum score 20-40 * Glasgow Coma Scale (GCS) ≥ 13, intact cough/gag, stable hemodynamics * Onset of respiratory symptoms ≤ 7 days Exclusion Criteria: * Chronic respiratory disease (COPD, interstitial lung diseases (ILD), persistent asthma) * Immediate need for invasive ventilation (VC \< 10 mL/kg, unresponsive severe gas-exchange derangement) * Severe bulbar dysfunction or prior intubation for the current illness * Contraindications to HVNC/NIV (facial trauma, untreated pneumothorax, agitation, vomiting) * Pregnancy * Severe comorbidity limiting prognosis. * Declined consent
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What it tests

  • Non-Invasive Ventilation (NIV)
  • High Velocity Nasal Insufflation
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Where

2 sites
Assuit Univeristy
Asyut, Egypt
Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt
Asyut, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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