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Early Mechanical Ventilation for Guillain Barré Syndrome

Primary Purpose

Guillain Barré Syndrome, Acute Respiratory Failure

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
mechanical ventilation
physiotherapy and oxygen if needed
Sponsored by
University of Versailles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Guillain Barré Syndrome focused on measuring Guillain Barré, Mechanical ventilation, invasive, Mechanical ventilation, non invasive, Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Glasgow coma score of less than 8 Unstable hemodynamic status Current pneumonia Pregnancy

Sites / Locations

  • Raymond Poincaré Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Physiotherapy, oxygen as needed

Mechanical ventilation

Outcomes

Primary Outcome Measures

Rate of hospital acquired pneumonia from randomization to study day 90

Secondary Outcome Measures

Time on a ventilator
Intensive care unit lenght of stay
Hospital length of stay
Tolerance

Full Information

First Posted
September 10, 2005
Last Updated
July 19, 2016
Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00167622
Brief Title
Early Mechanical Ventilation for Guillain Barré Syndrome
Official Title
Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Hospital acquired pneumonia is a common and severe complication of Guillain Barré Syndrome. Several factors have been recognized as predictors of respiratory failure in adults with Guillain Barré Syndrome. They include a time from disease onset and patient admission of less seven days, inability to lift head, impaired swallowing and a forced vital capacity of less than 60% of predictive value. We reasonned that early mechanical ventilation may prevent aspiration which is likely the main cause of pneumonia in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain Barré Syndrome, Acute Respiratory Failure
Keywords
Guillain Barré, Mechanical ventilation, invasive, Mechanical ventilation, non invasive, Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Physiotherapy, oxygen as needed
Arm Title
2
Arm Type
Experimental
Arm Description
Mechanical ventilation
Intervention Type
Procedure
Intervention Name(s)
mechanical ventilation
Intervention Description
Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation
Intervention Type
Procedure
Intervention Name(s)
physiotherapy and oxygen if needed
Intervention Description
oxygen will be delivered via facial mask whenever needed and physiotherapy
Primary Outcome Measure Information:
Title
Rate of hospital acquired pneumonia from randomization to study day 90
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Time on a ventilator
Time Frame
Day 90
Title
Intensive care unit lenght of stay
Time Frame
Day 90
Title
Hospital length of stay
Time Frame
Day 90
Title
Tolerance
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Glasgow coma score of less than 8 Unstable hemodynamic status Current pneumonia Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djillali annane, MD, PhD
Organizational Affiliation
Raymond Poincaré Hospital, AP-HP
Official's Role
Study Chair
Facility Information:
Facility Name
Raymond Poincaré Hospital
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12545029
Citation
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.
Results Reference
background
PubMed Identifier
1928954
Citation
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.
Results Reference
background
PubMed Identifier
32997260
Citation
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.
Results Reference
derived

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Early Mechanical Ventilation for Guillain Barré Syndrome

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