Breathing support options for adults with Guillain-Barré respiratory failure

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

This will test whether high-velocity nasal cannula or bi-level noninvasive ventilation works better for adults with Guillain-Barré syndrome who have severe breathing problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assiut University (Academic / other)
• Locations: 2 sites (Asyut, Assuit and 1 other locations)
• Trial ID: NCT06996509 on ClinicalTrials.gov

What this trial studies

This interventional study will enroll 70 adults with Guillain-Barré syndrome and moderate acute respiratory failure to compare high-velocity nasal cannula (HVNC) and bi-level noninvasive ventilation (NIV). Participants will be assigned to receive either HVNC (heated, humidified flow 35–60 L/min) or bi-level NIV (IPAP 10–16 cmH2O and EPAP 5–8 cmH2O) and followed for 30 days. The primary outcome is liberation from non-invasive support without need for invasive mechanical ventilation by Day 30, with secondary outcomes including time to discontinuation, patient comfort, ICU and hospital length of stay, ventilator-free days, and 30-day mortality. Entry criteria focus on adults with recent respiratory symptom onset and specified respiratory function and neurologic scores, while those with chronic lung disease, severe bulbar dysfunction, or immediate need for intubation are excluded.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with Guillain-Barré syndrome who developed moderate acute respiratory failure within 7 days, meet specified breathing and neurologic score thresholds (e.g., VC 15–20 mL/kg, Hughes grade 3–4, EGRIS 1–3), and are hemodynamically stable with intact airway reflexes.

Not a fit: Patients who already need immediate invasive ventilation, have severe bulbar dysfunction, chronic respiratory disease, or contraindications to HVNC/NIV are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the trial could identify a more comfortable respiratory support method that reduces the need for invasive ventilation and shortens ICU and hospital stays.

How similar studies have performed: Noninvasive ventilation is an established treatment in other causes of respiratory failure and high-flow nasal therapies have shown benefits in some populations, but direct comparisons in Guillain-Barré syndrome remain relatively novel.

Eligibility criteria

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

Where this trial is running

Asyut, Assuit and 1 other locations

• Assuit Univeristy — Asyut, Assuit, Egypt (Recruiting)
• Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt — Asyut, Egypt (Recruiting)

Study contacts

• Principal investigator: Ahmad M. Shaddad, MD — Assiut University
• Study coordinator: Ahmad M. Shaddad, MD

Conditions Guillain-Barre Syndrome; GBS