Guillain-Barre SyndromeNCT06996509
Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome
A study testing Non-Invasive Ventilation (NIV) and High Velocity Nasal Insufflation in people with Guillain-Barre Syndrome, run by Assiut University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Non-Invasive Ventilation (NIV) and High Velocity Nasal Insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Assuit Univeristy
Asyut, Assuit, 71515
Ahmad M. Shaddad, MD, +201111171930, shaddad_ahmad@yahoo.com
shaddad_ahmad@yahoo.com
- Recruiting
Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt
Asyut, 71515
Ahmad M. shaddad, MD, +201111171930, shaddad_ahmad@aun.edu.eg
About this study
Official title: Prospective, Randomized, Controlled, Open-Label Single-Center Trial Comparing High-Velocity Nasal Insufflation (HVNI) Versus Non-Invasive Ventilation (NIV) for Acute Respiratory Failure in Guillain-Barré Syndrome
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.
Read the detailed description
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.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- Non-Invasive Ventilation (NIV), High Velocity Nasal Insufflation
- Keywords
- GBS
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Ventilation (NIV)Device
Also called Bi-level Positive airway pressure ventilation (BIPAP)
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
High Velocity Nasal InsufflationDevice
Also called High velocity nasal cannula, Vapotherm Delivery system
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 %
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Ventilation (NIV) | Experimental | 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%. Receives: Device: Non-Invasive Ventilation (NIV) |
| High velocity nasal insufflation (HVNI) | Experimental | 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 %. Receives: Device: High Velocity Nasal Insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after randomization and daily for 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study employs a parallel assignment model with randomized allocation in an open-label design. In this framework, participants are prospectively assigned by chance to one of two concurrent intervention arms and remain in that arm throughout the trial. At the same time, both investigators and patients are aware of the assigned treatment. This arrangement improves the trustworthiness of the results by avoiding any leftover effects from earlier treatments, ensures that the groups are similar for comparison by randomly choosing participants, and makes it easier to provide quick respiratory support for Guillain-Barré syndrome.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M. Shaddad, MD, Principal investigator, Assiut UniversityAliae A. Hussien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996509
- Sponsor's protocol ID
- 237890-5-2025
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Open-Label Single-Center Trial Comparing High-Velocity Nasal Insufflation (HVNI) Versus Non-Invasive Ventilation (NIV) for Acute Respiratory Failure in Guillain-Barré Syndrome
- ClinicalTrials.gov ID
- NCT06996509
- Acronym / sponsor ID
- 237890-5-2025
- Conditions
- Guillain-Barre Syndrome
- Keywords
- GBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study employs a parallel assignment model with randomized allocation in an open-label design. In this framework, participants are prospectively assigned by chance to one of two concurrent intervention arms and remain in that arm throughout the trial. At the same time, both investigators and patients are aware of the assigned treatment. This arrangement improves the trustworthiness of the results by avoiding any leftover effects from earlier treatments, ensures that the groups are similar for comparison by randomly choosing participants, and makes it easier to provide quick respiratory support for Guillain-Barré syndrome.
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Ventilation (NIV) | Experimental | Device: Non-Invasive Ventilation (NIV)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%. |
| High velocity nasal insufflation (HVNI) | Experimental | Device: High Velocity Nasal InsufflationDevice \& 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 %. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Ventilation (NIV)Also: Bi-level Positive airway pressure ventilation (BIPAP)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 | Device | Non-Invasive Ventilation (NIV) |
| High Velocity Nasal InsufflationAlso: High velocity nasal cannula, Vapotherm Delivery systemHigh-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 % | Device | High velocity nasal insufflation (HVNI) |
Primary outcome
Maximize the successful weaning duration in days.
Time frame: 48 hours after randomization and daily for 28 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad M. Shaddad, MD principal investigator
Assiut University
Aliae A. Hussien, MD principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Ventilation (NIV) and High Velocity Nasal Insufflation in people with Guillain-Barre Syndrome, run by Assiut University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M. Shaddad, MD (+201111171930, shaddad_ahmad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximize the successful weaning duration in days. (time frame: 48 hours after randomization and daily for 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.