Respiratory Insufficiency Clinical Trial
— DYVINEOfficial title:
Study of Efficacy and Tolerance of Early Launching of Nocturnal Non Invasive Ventilation in Adults With Myotonic Dystrophy Type 1(DM1)
Verified date | November 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter randomized controlled open labeled study testing efficacy and tolerance of early launching of night non invasive ventilation in patients with myotonic dystrophy type 1(DM1). The object of this project is to estimate the effects of the early introduction of non invasive ventilation on the arisen of complication (non expected hospitalization, tracheostomy even death) with regard to a simple respiratory follow-up in patients affected by myotonic dystrophy.
Status | Active, not recruiting |
Enrollment | 77 |
Est. completion date | December 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Man or woman of age = 18 years - Preliminary medical examination - Enlightened and written consent - Genetically proved Steinert disease 1. Presenting at least one of the following 3 criteria - A hypercapnia: PaCO2 > 45 mmHg or - A night-desaturation: SaO2 < 88 % more than consecutive 5 minutes or - Apnea syndrome with significant sleep:index of apnea / hypopnea> a 30 / hour 2. And with presence of at least a clinical sign: dyspnoea, orthopnea, headaches, asthenia, diurnal sleepiness, or any other sign suggestive of disturbance of the sleep or of respiratory dysfunction Exclusion Criteria: - Age inferior to 18 - Regime of legal protection - Pregnancy - Absolute indication for ventilation: clinical signs (dyspnoea, orthopnea, headaches, asthenia, diurnal sleepiness), AND PaCO2 > 60 mmHg, AND night-desaturation < 88 % AND one CV < 50 % of the theoretical or the PIMAX < 60 cm H2O - Acute respiratory failure - Already ventilated patient - Patient under oxygen - Not (beneficiary to a regime of Social Security or legal successor) |
Country | Name | City | State |
---|---|---|---|
France | Home ventilation unit and intensive care, centre of neuromuscular disease (Garches Mondor Necker Hendaye), Raymond Poincaré hospital Versailles Saint Quentin University. | Garches |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Association Française contre les Myopathies (AFM), Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients having a complication (number of non expected hospitalization or death) at 5 years. | Rate of patients having a complication (number of non expected hospitalization or death) at 5 years. | 5 YEARS | |
Secondary | Distribution of survival between the randomisation at 5 years | Distribution of survival between the randomisation at 5 years | 5 YEARS | |
Secondary | Number of patients having a formal indication of ventilation | Number of patients having a formal indication of ventilation | 5 YEARS | |
Secondary | Number of tracheostomized patients at 5 years | Number of tracheostomized patients at 5 years | 5 YEARS | |
Secondary | Number of non expected hospitalizations at 5 years | Number of non expected hospitalizations at 5 years | 5 YEARS | |
Secondary | Observance of the ventilation defined by an average minimal use of 4 am by 12:00 pm . | Observance of the ventilation defined by an average minimal use of 4 am by 12:00 pm (determined in a objective way by the counter of the device). | 5 YEARS | |
Secondary | Degree of respiratory and sleep impairment at 5 years | Degree of respiratory and sleep impairment at 5 years | 5 YEARS | |
Secondary | Quality of life SF36, scales of depression | Quality of life SF36, scales of depression | 5 YEARS |
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