RecruitingNot ApplicableNCT06996509

Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

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

Sponsor

Assiut University

Enrollment

80 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Guillain-Barre Syndrome

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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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Interventions

DEVICENon-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

DEVICEHigh 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 %