Status:
NOT_YET_RECRUITING
Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome
Lead Sponsor:
Assiut University
Conditions:
Guillain-Barre Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 del...
Detailed Description
Guillain-Barré Syndrome (GBS) is an acute autoimmune disorder characterized by rapid-onset muscle weakness due to peripheral nerve damage. A significant complication in GBS is respiratory failure, occ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06996509
Start Date
August 1 2025
End Date
November 1 2026
Last Update
May 30 2025
Active Locations (1)
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1
Assuit Univeristy
Asyut, Assuit, Egypt, 71515