NCT06996509 Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome
| NCT ID | NCT06996509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assiut University |
| Condition | Guillain-Barre Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-08-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Ahmad M. Shaddad, MD
PRINCIPAL INVESTIGATOR
Assiut University
Frequently Asked Questions
Who can join the NCT06996509 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Guillain-Barre Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06996509 currently recruiting?
Yes, NCT06996509 is actively recruiting participants. Contact the research team at shaddad_ahmad@yahoo.com for enrollment information.
Where is the NCT06996509 trial being conducted?
This trial is being conducted at Asyut, Egypt, Asyut, Egypt.
Who is sponsoring the NCT06996509 clinical trial?
NCT06996509 is sponsored by Assiut University. The principal investigator is Ahmad M. Shaddad, MD at Assiut University. The trial plans to enroll 80 participants.