Guillain Barré SyndromePhase 2NCT00167622
Early Mechanical Ventilation for Guillain Barré Syndrome
A Phase 2 study testing mechanical ventilation and physiotherapy and oxygen if needed in people with Guillain Barré Syndrome and Acute Respiratory Failure, run by University of Versailles at 1 site in France.
Trial summary
The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guillain Barré Syndrome, Acute Respiratory Failure
- What is being tested?
- mechanical ventilation and physiotherapy and oxygen if needed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- Glasgow coma score of less than 8
- Unstable hemodynamic status
- Current pneumonia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome
The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.
Read the 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.
- Conditions
- Guillain Barré Syndrome, Acute Respiratory Failure
- Being tested
- mechanical ventilation, physiotherapy and oxygen if needed
- Keywords
- Guillain Barré, Mechanical ventilation, invasive, Mechanical ventilation, non invasive, Pneumonia
- Medical subject headings
- Guillain-Barre Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
Non invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation
physiotherapy and oxygen if neededProcedure or surgery
oxygen will be delivered via facial mask whenever needed and physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Physiotherapy, oxygen as needed Receives: Procedure: physiotherapy and oxygen if needed |
| 2 | Experimental | Mechanical ventilation Receives: Procedure: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospital acquired pneumonia from randomization to study day 90
Measured: Day 90
Secondary outcomes (4)
Time on a ventilator
Measured: Day 90
Intensive care unit lenght of stay
Measured: Day 90
Hospital length of stay
Measured: Day 90
Tolerance
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Guillain Barré SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Djillali Annane, University of Versailles
- Investigators
- Djillali annane, MD, PhD, Study chair, Raymond Poincaré Hospital, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167622
- Sponsor's protocol ID
- P050103
- Other IDs
- PS050103
- Status last verified
- Jul 2016
- First submitted
- 10 Sep 2005
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12545029Chevrolet 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.
PubMed 1928954Melone 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.
PubMed 32997260
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome
- ClinicalTrials.gov ID
- NCT00167622
- Acronym / sponsor ID
- P050103
- Conditions
- Guillain Barré Syndrome, Acute Respiratory Failure
- Keywords
- Guillain Barré, Mechanical ventilation, invasive, Mechanical ventilation, non invasive, Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Apr 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: physiotherapy and oxygen if neededPhysiotherapy, oxygen as needed |
| 2 | Experimental | Procedure: mechanical ventilationMechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Glasgow coma score of less than 8
- Unstable hemodynamic status
- Current pneumonia
- 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 |
|---|---|---|
| mechanical ventilationNon invasive mechanical ventilation at least 6 hours per day - if difficult swallowing, tracheal intubation and invasive mechanical ventilation | Procedure or surgery | 2 |
| physiotherapy and oxygen if neededoxygen will be delivered via facial mask whenever needed and physiotherapy | Procedure or surgery | 1 |
Primary outcome
Rate of hospital acquired pneumonia from randomization to study day 90
Time frame: Day 90
4 secondary outcomes
Time on a ventilator
Time frame: Day 90
Intensive care unit lenght of stay
Time frame: Day 90
Hospital length of stay
Time frame: Day 90
Tolerance
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Background: PubMed 12545029Sharshar 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.
- Background: PubMed 1928954Chevrolet 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.
- Derived from this study: PubMed 32997260Melone 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.
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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. This study is not recruiting at the moment.
Djillali annane, MD, PhD study chair
Raymond Poincaré Hospital, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mechanical ventilation and physiotherapy and oxygen if needed in people with Guillain Barré Syndrome and Acute Respiratory Failure, run by University of Versailles at 1 site in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hospital acquired pneumonia from randomization to study day 90 (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00167622, which also lists 3 linked publications.
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 20 Jul 2016.