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Clinical Trials in Egypt / NCT06996509
Recruiting Not applicable

Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

NCT06996509 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Not applicable
Started
2025-08-01
Last updated
2026-09-22

Condition(s) studied

Guillain-Barre Syndrome

Investigational drug(s) / intervention(s)

Non-Invasive Ventilation (NIV)High Velocity Nasal Insufflation

Non-Invasive Ventilation (NIV): 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

High Velocity Nasal Insufflation: High-Velocity Nasal Cannula therapy delivers heated, humidified gas at flow rates exceeding patients' peak inspiratory demands (35-60 L/min), with precise FiO₂ control up to 100 %

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Maximize the successful weaning duration in days. — 48 hours after randomization and daily for 28 days.
    Examine and compare the percentage of Guillain-Barré syndrome patients who can discontinue using their assigned non-invasive support (HVNC or NIV) without requiring a switch to invasive mechanical ventilation during their initial stay in the intensive care unit (ICU), which will be from 48 hours of randomization and daily for 28 days.

Trial sites (2)

FacilityCityRegionStatus
Assuit Univeristy Asyut Assuit Recruiting
Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt Asyut Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06996509 on ClinicalTrials.gov ↗ ← All trials in Egypt