NCT07022028

Brief Summary

Guillain-Barré syndrome and myasthenia gravis are two neuromuscular diseases that are commonly managed in ICUs that may require different weaning protocols. To date, no study has compared weaning modalities from mechanical ventilation in patients with these two diseases. Our objective was to assess and compare for ventilator weaning modalities between patients mechanically ventilated for Guillain-Barré syndrome or for myasthenia gravis in a large-scale multicenter study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 6, 2025

Last Update Submit

June 13, 2025

Conditions

Myasthenia GravisGuillain-Barre Syndrome

Keywords

Myasthenia GravisGuillain-Barre syndromeVentilator WeaningAirway ExtubationIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with prolonged weaning

    Prolonged weaning defined as still being under mechanical ventilation at least 7 days after the initial separation attempt from the ventilator

    7 days after the initial separation attempt from the ventilator

Study Arms (1)

Patients mechanically ventilated for Guillain-Barré syndrome or for myasthenia gravis (two groups)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients intubated and mechanically ventilated in ICUs for Guillain-Barré syndrome or myasthenia gravis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de POITIERS

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Myasthenia GravisGuillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPolyradiculoneuropathyDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud W THILLE, MD, PhD

    University Hospital of Poitiers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 15, 2025

Study Start

February 27, 2024

Primary Completion

November 6, 2024

Study Completion

November 6, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations

FR(1)