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Search / Trial NCT06996509

Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

Launched by ASSIUT UNIVERSITY · May 21, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Gbs

ClinConnect Summary

This clinical trial is studying two different types of breathing support for adults with Guillain-Barré Syndrome (GBS) who are experiencing severe breathing problems. The trial will involve 70 participants who will be given either high-velocity nasal cannula (HVNC), which delivers warm, moist air through a nosepiece, or bi-level noninvasive ventilation (NIV), which uses different air pressures to help with breathing. The main goal is to see how many patients can stop using these non-invasive methods and breathe on their own without needing a ventilator by Day 30 of the study. Researchers will also look at how comfortable patients feel, how long they stay in the hospital, and other important health outcomes.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with Guillain-Barré Syndrome, showing specific signs of breathing difficulties. They should not have any chronic respiratory diseases or serious complications that require immediate invasive breathing support. Participants can expect close monitoring and support throughout the study, helping researchers learn which method of breathing assistance works best for patients with GBS. This trial is not yet recruiting, so there will be more information available as it progresses.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Assiut, Assuit, Egypt

Patients applied

0 patients applied

Trial Officials

Ahmad M. Shaddad, MD

Principal Investigator

Assiut University

Aliae A. Hussien, MD

Principal Investigator

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported