Noninvasive Support for Acute Respiratory Failure in Guillain-Barré Syndrome

NCT06996509 | Recruiting

• 1 other identifier: 237890-5-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Guillain-Barre Syndrome

Keywords

GBS

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours after randomization and daily for 28 days.

Study Arms (2)

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%.

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 %.

Device: High Velocity Nasal Insufflation

Interventions

Non-Invasive Ventilation (NIV) DEVICE

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)

Non-Invasive Ventilation (NIV)

High Velocity Nasal Insufflation DEVICE

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

High velocity nasal insufflation (HVNI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assuit Univeristy

Asyut, Assuit, 71515, Egypt

RECRUITING

Faculty of Medicine - Assiut University Hospitals - Assiut University - Egypt

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ahmad M. Shaddad, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M. Shaddad, MD

CONTACT

+201111171930; shaddad_ahmad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor blinding involves masking only those individuals who measure or adjudicate study endpoints, while participants and treating clinicians remain aware of treatment allocation. This approach reduces detection bias in outcome measurement without the logistical challenges of fully double-blinded designs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

EG (2)