Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06996509

Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

Led by Assiut University · Updated on 2026-04-30

80

Participants Needed

2

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with Guillain-Barré Syndrome using Brighton criteria including clinical and diagnostic tests
  • Moderate acute respiratory failure defined by vital capacity 15-20 mL/kg and/or carbon dioxide > 45 mmHg or oxygen < 70 mmHg on room air and/or respiratory rate > 24 per minute
  • Hughes Grade 3-4, EGRIS 1-3, and Medical Research Council sum score between 20 and 40
  • Glasgow Coma Scale score 13 or higher, able to cough and gag, and stable blood circulation
  • Respiratory symptoms started within the last 7 days
Not Eligible

You will not qualify if you...

  • Chronic respiratory diseases such as COPD, interstitial lung diseases, or persistent asthma
  • Immediate need for invasive ventilation due to very low vital capacity (< 10 mL/kg) or severe gas exchange problems
  • Severe bulbar dysfunction or prior intubation during this illness
  • Contraindications to HVNC or NIV including facial trauma, untreated pneumothorax, agitation, or vomiting
  • Pregnancy
  • Severe health conditions limiting life expectancy
  • Declined to give consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Assuit Univeristy

Asyut, Assuit, Egypt, 71515

Actively Recruiting

2

Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt

Asyut, Egypt, 71515

Actively Recruiting

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Research Team

A

Ahmad M. Shaddad, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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