Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome
Recruiting now · Not applicable
Conditions studied: Guillain-Barre Syndrome
In brief
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, 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.
Key facts
- Study ID
- NCT06996509
- Run by
- Assiut University
- People needed
- 80
- Starts
- 2025-08-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Assuit Univeristy — Asyut, Assuit, Egypt (enrolling)
- Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt — Asyut, Egypt (enrolling)
Full record on ClinicalTrials.gov
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