NCT00167622

Brief Summary

The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2005

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3.8 years

First QC Date

September 10, 2005

Last Update Submit

July 19, 2016

Conditions

Guillain Barré SyndromeAcute Respiratory Failure

Keywords

Guillain BarréMechanical ventilation, invasiveMechanical ventilation, non invasivePneumonia

Outcome Measures

Primary Outcomes (1)

  • Rate of hospital acquired pneumonia from randomization to study day 90

    Day 90

Secondary Outcomes (4)

  • Time on a ventilator

    Day 90

  • Intensive care unit lenght of stay

    Day 90

  • Hospital length of stay

    Day 90

  • Tolerance

    Day 90

Study Arms (2)

1

ACTIVE COMPARATOR

Physiotherapy, oxygen as needed

Procedure: physiotherapy and oxygen if needed

2

EXPERIMENTAL

Mechanical ventilation

Procedure: mechanical ventilation

Interventions

mechanical ventilationPROCEDURE

Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation

2
physiotherapy and oxygen if neededPROCEDURE

oxygen will be delivered via facial mask whenever needed and physiotherapy

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Guillain Barré Syndrome
  • Age of 18 years old or more
  • Inability to lift head
  • Time from onset of motor deficit less than 7 days
  • Written informed consent

You may not qualify if:

  • Glasgow coma score of less than 8
  • Unstable hemodynamic status
  • Current pneumonia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincaré Hospital

Garches, 92380, France

Location

Related Publications (3)

  • Sharshar T, Chevret S, Bourdain F, Raphael JC; French Cooperative Group on Plasma Exchange in Guillain-Barre Syndrome. Early predictors of mechanical ventilation in Guillain-Barre syndrome. Crit Care Med. 2003 Jan;31(1):278-83. doi: 10.1097/00003246-200301000-00044.

    PMID: 12545029BACKGROUND

  • Chevrolet JC, Deleamont P. Repeated vital capacity measurements as predictive parameters for mechanical ventilation need and weaning success in the Guillain-Barre syndrome. Am Rev Respir Dis. 1991 Oct;144(4):814-8. doi: 10.1164/ajrccm/144.4.814.

    PMID: 1928954BACKGROUND

  • Melone MA, Heming N, Meng P, Mompoint D, Aboab J, Clair B, Salomon J, Sharshar T, Orlikowski D, Chevret S, Annane D. Early mechanical ventilation in patients with Guillain-Barre syndrome at high risk of respiratory failure: a randomized trial. Ann Intensive Care. 2020 Sep 30;10(1):128. doi: 10.1186/s13613-020-00742-z.

    PMID: 32997260DERIVED

MeSH Terms

Conditions

Guillain-Barre SyndromePneumonia

Interventions

Respiration, ArtificialPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory TherapyRehabilitation

Study Officials

  • Djillali annane, MD, PhD

    Raymond Poincaré Hospital, AP-HP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in medicine

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 14, 2005

Study Start

April 1, 2005

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

FR(1)