Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

Официальное название

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

Обзор

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.

Подробное описание

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, occurring in approximately 25% of cases, necessitating timely and effective respiratory support to prevent morbidity and mortality.

Non-invasive ventilation (NIV) is a standard intervention for managing acute respiratory failure, particularly in conditions such as chronic obstructive pulmonary disease (COPD). NIV delivers positive pressure ventilation through interfaces such as oronasal masks, providing support without the need for endotracheal intubation. While effective, NIV can be associated with patient discomfort, skin breakdown, and challenges in secretion management, potentially leading to intolerance or failure of the therapy.

High-flow nasal cannula (HFNC) therapy has emerged as an alternative respiratory support modality. HFNC delivers heated and humidified oxygen at high flow rates through nasal prongs, offering several physiological benefits:

Enhanced Oxygenation: By delivering high flow rates, HFNC can meet or exceed the patient's inspiratory demand, ensuring consistent oxygen delivery.

Reduction in Work of Breathing: The continuous flow can generate a low level of positive airway pressure, decreasing the effort required for breathing.

Enhanced Secretion Clearance: Humidified gas supports mucociliary function, facilitating the clearance of secretions.

Patient Comfort: The nasal interface is generally better tolerated than masks used in non-invasive ventilation (NIV), potentially improving adherence to therapy.

Recent studies have explored the efficacy of HFNC compared to NIV in various forms of respiratory failure. While NIV remains the first-line treatment in many scenarios, HFNC has shown promise in improving patient comfort and reducing the need for escalation to invasive mechanical ventilation in specific patient populations.

Вмешательства

• Устройство 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
• Устройство 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 %

Первичные конечные точки

• Maximize the successful weaning duration in days. [Срок оценки: 48 hours after randomization and daily for 28 days.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Египет · 2 центра

• Assuit Univeristy — Asyut
• Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt — Asyut

Идентификаторы

NCT: NCT06996509 · 237890-5-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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