TetraplegiaDGVSBNCT01024088
Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.
An observational study of Tetraplegia and Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetraplegia, Respiratory Failure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Jul 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patient admitted in ICU with GBS and respiratory risk
Who may be able to join
- Guillain Barré Syndrome
- Presenting a risk of mechanical ventilation(breakdown): presence of 2 among the following 5 criteria
- Deficit evolving for less than 7 days
- Impossibility to stand up
- Impossibility to raise the head
- ineffective Cough
- Vital capacity< 60 %
Who cannot join
- MAJOR confusions of gulp (spontaneous) at admittance
- Respiratory distress syndrome and intubation at admission buccal dental lesions
- Not membership to a regime of Social Security (beneficiary or legal successor)
- Patient under guardianship or custody
Trial locations and contacts
1 site in 1 country.
About this study
To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.
Read the detailed description
Context: the syndrome of Guillain Barré ( SGB) is the first causes of extensive paralysis of medical origin in industrial nations. A third of these patients going to require mechanical invasive ventilation during their stay in ICU. This population of ventilated presents the strongest risk of infectious respiratory patient complications and death. The respiratory impairment is a progressive weakness of inspiratory and expiratory muscles. The monitoring of the respiratory muscular infringement is usually made by the repeated measure of vital capacity and the maximal respiratory pressures. The occurrence of bulbar impairment is an aggravating element entailing dysfunction of the upper airways muscles detected often late in front of aspiration. Besides the arisen of sleep apneas was never sought in this context. This dysfunction of the upper airways muscles could be more detected prematurely by objectivizes measures of them performances.
Method: longitudinal observational and in a one center study. The respiratory impairment will be estimated by the measure of the vital capacity, maximal respiratory pressures and of the debit of cough. The existence of a bulbar infringement will be sought by the measure of the force of the tongue, an objective measure of gulp performances and a polysomnographic recording.
Criterion of selection: patient admitted in ICU with GBS and respiratory risk. Number of patients, centre: 40 patients admitted in the intensive care unit of the hospital RAYMOND POINCARE and 20 controls.
Duration of the study: 24 months Perspectives: better anticipate acute respiratory failure and the indication of an invasive ventilation.
- Conditions
- Tetraplegia, Respiratory Failure
- Keywords
- Guillain Barré syndrome, Swallowing disorders, Respiratory failure
- Medical subject headings
- Quadriplegia, Respiratory Insufficiency, Guillain-Barre Syndrome, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GBS PATIENT | Not described | |
| CONTROL | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between respiratory failure and bulbar dysfunction during ICU stay
Measured: 24 MONTHS
Secondary outcomes (1)
Number of aspiration pneumonia
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Orlikowski, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024088
- Sponsor's protocol ID
- P061016 -CRC 06040
- Acronym
- DGVSB
- Status last verified
- Feb 2011
- First submitted
- 30 Nov 2009
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.
- ClinicalTrials.gov ID
- NCT01024088
- Acronym / sponsor ID
- DGVSB / P061016 -CRC 06040
- Conditions
- Tetraplegia, Respiratory Failure
- Keywords
- Guillain Barré syndrome, Swallowing disorders, Respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Dec 2009 (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.
To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.
Detailed description
Context: the syndrome of Guillain Barré ( SGB) is the first causes of extensive paralysis of medical origin in industrial nations. A third of these patients going to require mechanical invasive ventilation during their stay in ICU. This population of ventilated presents the strongest risk of infectious respiratory patient complications and death. The respiratory impairment is a progressive weakness of inspiratory and expiratory muscles. The monitoring of the respiratory muscular infringement is usually made by the repeated measure of vital capacity and the maximal respiratory pressures. The occurrence of bulbar impairment is an aggravating element entailing dysfunction of the upper airways muscles detected often late in front of aspiration. Besides the arisen of sleep apneas was never sought in this context. This dysfunction of the upper airways muscles could be more detected prematurely by objectivizes measures of them performances.
Method: longitudinal observational and in a one center study. The respiratory impairment will be estimated by the measure of the vital capacity, maximal respiratory pressures and of the debit of cough. The existence of a bulbar infringement will be sought by the measure of the force of the tongue, an objective measure of gulp performances and a polysomnographic recording.
Criterion of selection: patient admitted in ICU with GBS and respiratory risk. Number of patients, centre: 40 patients admitted in the intensive care unit of the hospital RAYMOND POINCARE and 20 controls.
Duration of the study: 24 months Perspectives: better anticipate acute respiratory failure and the indication of an invasive ventilation.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBS PATIENT | – | – |
| CONTROL | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient admitted in ICU with GBS and respiratory risk
Key inclusion criteria (7 listed)
- Guillain Barré Syndrome
- Presenting a risk of mechanical ventilation(breakdown): presence of 2 among the following 5 criteria
Key exclusion criteria (4 listed)
- MAJOR confusions of gulp (spontaneous) at admittance
- Respiratory distress syndrome and intubation at admission buccal dental lesions
- Not membership to a regime of Social Security (beneficiary or legal successor)
- Patient under guardianship or custody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between respiratory failure and bulbar dysfunction during ICU stay
Time frame: 24 MONTHS
1 secondary outcome
Number of aspiration pneumonia
Time frame: 24 MONTHS
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 16 Sep 2014.
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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.
David Orlikowski, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetraplegia and Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris 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 7 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 16 Sep 2014. 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.
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?
Correlation between respiratory failure and bulbar dysfunction during ICU stay (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2014.