Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06996509

Trial Comparing High-Velocity Nasal Insufflation Versus Non-Invasive Ventilation for Respiratory Failure in Guillain-Barré Syndrome

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

80

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate respiratory support methods for adult patients with Guillain-Barré syndrome who experience severe breathing problems. Guillain-Barré syndrome is a rapid-onset nerve disorder causing muscle weakness, sometimes leading to respiratory failure requiring urgent support. The study compares two types of non-invasive breathing assistance to determine which helps more patients avoid needing invasive breathing machines by Day 30. Secondary goals include assessing comfort, hospital stay length, breathing independence, and survival rates within 30 days. The study compares high-velocity nasal cannula (HVNC) therapy, which delivers heated and humidified air at 35-60 liters per minute through nasal prongs, to bi-level non-invasive ventilation (NIV) that provides two pressure levels through a mask. NIV uses inspiratory positive airway pressure of 10-16 cmH2O and expiratory positive airway pressure of 5-8 cmH2O, with oxygen levels adjusted to keep blood oxygen saturation at or above 92%. Both treatments are delivered continuously with adjustments based on patient needs. Participants will be monitored from 48 hours after starting treatment and daily for 28 days, tracking how long they successfully use non-invasive support without needing invasive ventilation. Researchers will assess patient comfort, length of ICU and hospital stays, days of independent breathing, and survival within 30 days. The study starts in August 2025 and will enroll 70 adults, with ongoing evaluation until November 2026.

CONDITIONS

Brief 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 per clinical and diagnostic criteria
  • Moderate acute respiratory failure with specific breathing measurements
  • Hughes Grade 3-4, EGRIS score 1-3, MRC sum score 20-40
  • Glasgow Coma Scale score 13 or higher, stable cough/gag reflex, and hemodynamics
  • Respiratory symptoms started within 7 days
Not Eligible

You will not qualify if you...

  • Chronic respiratory diseases such as COPD, interstitial lung disease, or persistent asthma
  • Immediate need for invasive ventilation due to severe respiratory failure
  • Severe bulbar dysfunction or prior intubation for current illness
  • Contraindications to HVNC or NIV like facial trauma, untreated pneumothorax, agitation, or vomiting
  • Pregnancy
  • Severe comorbid conditions limiting prognosis
  • Declined consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Up to 28 days after randomization

Participants receive assigned respiratory support using either Non-Invasive Ventilation (NIV) or High Velocity Nasal Insufflation (HVNI) to manage acute respiratory failure in Guillain-Barré Syndrome.

Daily visits for up to 28 days

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

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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