An interventional study of Non-Invasive Ventilation (NIV) and High Velocity Nasal Insufflation in Guillain-Barre Syndrome, sponsored by Assiut University. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Assiut University · Not applicable, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 11 studies in Guillain-Barre Syndrome by Assiut University — 6 open to participants now, 6 under way, none of them phase 3. Guillain-Barre Syndrome · Assiut University.
Among the 11 studies in Guillain-Barre Syndrome by Assiut University, this one is the only one that started in 2025, is one of 2 with no phase, and was the 9th registered.
98 studies on the registry are indexed under Guillain-Barre Syndrome; 30 are open to participants now.
Browse Guillain-Barre Syndrome studies →6 of the 11 studies in Guillain-Barre Syndrome by Assiut University are open now, in 1 country. Recruiting first, the newest first:
Assiut University · Sites in Egypt
Ages 18–75 · Healthy volunteers
Assiut University
Ages 1–17
Assiut University
Ages 1 mo–18 yrs
Assiut University
Ages 2–18
Assiut University
Ages 18–65 · Healthy volunteers
By country, each count listing its studies:
Of the 12 Guillain-Barre Syndrome studies recruiting now, 6 (50%) set no upper age limit and 3 (25%) stop at 75 or younger; 5 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 50 across 44 interventional studies indexed under Guillain-Barre Syndrome.
Median enrollment 80 across the 3 interventional studies, 67 across the 8 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
4 of the studies in Guillain-Barre Syndrome by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06996509Assiut UniversityNoninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome | 2026-12-01 |
| NCT06615622Assiut UniversityOur Study Aims to Determine if Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and if This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes. | 2027-03-30 |
| NCT07842705Assiut UniversityMyocardial Changes in Pediatric Guillain-Barré Syndrome | 2027-09-26 |
| NCT07866898Assiut UniversityPeripheral Nerve Ultrasound in Children With Guillain-Barré Syndrome | 2027-10-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 11 studies in Guillain-Barre Syndrome by Assiut University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Guillain-Barré Syndrome (GBS) is an acute autoimmune disorder characterized by rapid-onset muscle weakness due to peripheral nerve damage. A significant complication in GBS is respiratory failure, occurring in approximately 25% of cases, necessitating timely and effective respiratory support to prevent morbidity and mortality.
Non-invasive ventilation (NIV) is a standard intervention for managing acute respiratory failure, particularly in conditions such as chronic obstructive pulmonary disease (COPD). NIV delivers positive pressure ventilation through interfaces such as oronasal masks, providing support without the need for endotracheal intubation. While effective, NIV can be associated with patient discomfort, skin breakdown, and challenges in secretion management, potentially leading to intolerance or failure of the therapy.
High-flow nasal cannula (HFNC) therapy has emerged as an alternative respiratory support modality. HFNC delivers heated and humidified oxygen at high flow rates through nasal prongs, offering several physiological benefits:
Enhanced Oxygenation: By delivering high flow rates, HFNC can meet or exceed the patient's inspiratory demand, ensuring consistent oxygen delivery.
Reduction in Work of Breathing: The continuous flow can generate a low level of positive airway pressure, decreasing the effort required for breathing.
Enhanced Secretion Clearance: Humidified gas supports mucociliary function, facilitating the clearance of secretions.
Patient Comfort: The nasal interface is generally better tolerated than masks used in non-invasive ventilation (NIV), potentially improving adherence to therapy.
Recent studies have explored the efficacy of HFNC compared to NIV in various forms of respiratory failure. While NIV remains the first-line treatment in many scenarios, HFNC has shown promise in improving patient comfort and reducing the need for escalation to invasive mechanical ventilation in specific patient populations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device \& Settings Bi-level positive airway pressure (BiPAP) is set with an inspiratory positive airway pressure (IPAP) of 10-16 cmH₂O and an expiratory positive airway pressure (EPAP) of 5-8 cmH₂O. Adjust the fraction of inspired oxygen (FiO₂) to achieve an oxygen saturation (SpO₂) of ≥ 92%.
Device: Non-Invasive Ventilation (NIV)
Device \& Settings The high-velocity nasal cannula system delivers heated, humidified gas at flow rates of 35-60 L/min. FiO₂ titrated to maintain SpO₂ ≥ 92 %.
Device: High Velocity Nasal Insufflation
Bi-Level NIV delivers two preset pressure levels-Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP)-via a tightly fitting mask interface
Also known as: Bi-level Positive airway pressure ventilation (BIPAP)
High-Velocity Nasal Cannula therapy delivers heated, humidified gas at flow rates exceeding patients' peak inspiratory demands (35-60 L/min), with precise FiO₂ control up to 100 %
Also known as: High velocity nasal cannula, Vapotherm Delivery system
Maximize the successful weaning duration in days.
Examine and compare the percentage of Guillain-Barré syndrome patients who can discontinue using their assigned non-invasive support (HVNC or NIV) without requiring a switch to invasive mechanical ventilation during their initial stay in the intensive care unit (ICU), which will be from 48 hours of randomization and daily for 28 days.
Time frame: 48 hours after randomization and daily for 28 days.
Plan to share: Yes — De-identified individual participant data supporting the primary and secondary outcomes, along with accompanying data dictionaries and the statistical analysis plan, will be made available by Assiut University's institutional data-sharing policies. Data will be accessible 6-36 months after publication to qualified researchers upon submission of a study proposal, approval by the University Research Ethics Committee, and execution of a data-use agreement.
Supporting information: Study protocol, Statistical analysis plan
Time frame: 6-36 months after publication
Access criteria: Qualified researchers must submit a study proposal, obtain approval from the University Research Ethics Committee, and execute a data-use agreement.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.