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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Maximize the successful weaning duration in days.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor blinding involves masking only those individuals who measure or adjudicate study endpoints, while participants and treating clinicians remain aware of treatment allocation. This approach reduces detection bias in outcome measurement without the logistical challenges of fully double-blinded designs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Non-Invasive Ventilation (NIV)
Device & Settings
Bi-level positive airway pressure (BiPAP) is set with an inspiratory positive airway pressure (IPAP) of 10-16 cmH₂O and an expiratory positive airway pressure (EPAP) of 5-8 cmH₂O.
Adjust the fraction of inspired oxygen (FiO₂) to achieve an oxygen saturation (SpO₂) of ≥ 92%.
干预措施: Non-Invasive Ventilation (NIV) (Device)
High velocity nasal insufflation (HVNI)
Device & Settings
The high-velocity nasal cannula system delivers heated, humidified gas at flow rates of 35-60 L/min.
FiO₂ titrated to maintain SpO₂ ≥ 92 %.
干预措施: High Velocity Nasal Insufflation (Device)
结局指标
主要结局
Maximize the successful weaning duration in days.
时间窗: 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.
次要结局
未报告次要终点
研究者
Ahmad Shaddad
Associate Professor
Assiut University