Which breathing aid works best for Guillain-Barré? new trial aims to find out
NCT ID NCT06996509
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two breathing support devices—high-velocity nasal cannula (HVNI) and non-invasive ventilation (NIV)—in 80 adults with Guillain-Barré syndrome who have serious breathing trouble. The goal is to see which device helps more patients avoid needing a breathing tube within 30 days. Researchers will also measure comfort, ICU and hospital stays, and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-Velocity Nasal Insufflation (HVNI) device and Non-Invasive Ventilation (NIV) device
- What this could lead to
- If one device works better, it could help more Guillain-Barré patients breathe without needing a breathing tube, reducing complications and hospital stays.
- What could go wrong
- This is a small, early-stage trial (80 patients) at one hospital, so results may not apply to everyone. Both devices are already used, so no major new risks, but individual responses vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assuit Univeristy
RECRUITINGAsyut, Assuit, 71515, Egypt
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Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt
RECRUITINGAsyut, 71515, Egypt
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