Status:
UNKNOWN
Cardiovascular Consequences of NIV Withdrawal in Patients With Myotonic Dystrophy
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Myotonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Myotonic dystrophy lead to highly heterogeneous, multisystemic symptoms including myotonia, progressive muscle weakness, cardiac conduction defects, cataract, metabolic dysfunction, and ex...
Detailed Description
NIV is a technique of assisted ventilation that does not use the endotracheal route as the interface between the patient and the ventilator. NIV by positive pressure assistance involves ventilating th...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients (\>18 yrs) suffering from myotonic dystrophy already treated by long term nocturnal non invasive ventilation for more than six months for a chronic hypercapnic respiratory failure (Level of PaCO2 at beginning of the treatment should be between 45 and 55 mmHg)
- Patients should use his (her) non-invasive ventilation more than 4 hours and less than 12 hours per day.
- Patients could have an associated obstructive or/and central sleep apnea.
- NIV treatment should be consider as "efficient ": To allow an improvement of PaCO2 during wakefulness in the morning when using NIV compared to PaCO2 at the beginning of the treatment; To allow an improvement of the nocturnal oxymetry compared to baseline (mean nocturnal SaO2 \> 90%).
- EXCLUSION CRITERIA:
- Patients with a concomitant respiratory condition contributing to daytime alveolar hypoventilation.
- Patients judged by investigators as at high cardiovascular risk, this contraindicating NIV withdrawal.
- Patients with cardiac failure and periodic breathing.
- Patients who have had an acute episode of respiratory failure in the previous month.
- Incapacitated patients in accordance with article L 1121-6 of the public health code.
- Patients treated by oral corticosteroids or oral long-term non-steroidal anti-inflammatory drugs (NSAID).
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00745238
Start Date
June 1 2008
End Date
December 1 2012
Last Update
August 13 2012
Active Locations (1)
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1
France.Functional Cardio-Respiratory Exploration Laboratory
Grenoble, Isere, France, 38000