Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform

Study Overview
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Brief Summary
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The main objective will be to determine the effectiveness of home non-invasive ventilation by flow-time and time-pressure curves analysis in a cohort of patients with this treatment by digital diagnosis platform.

Detailed Description
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A multicenter study with observational prospective design will be implemented on 3 spanish hospitals in Barcelona. Inclusion criteria will be equivalent sample size of patients with restrictive lung disease, neuromuscular pathology and hypoventilation-obesity. Digital diagnosis platform will be used to incorporate and unify signals of different medical devices: a pneumotachograph on branch ventilator that captures pressure and flow-time signals, inductance plethysmography used to like a patient effort sensor and portable pulse oximeter recordings. Nocturnal polygraphic or polysomnographic tracings performed and recorded on sites will be processed systematically by main asynchronies diagnosis algorithms between patient and ventilator. These algorithms providing global and fractionated asynchronies count based on time, leaks or saturation criteria which will be used to compared effective ventilation phases and phases with nocturnal desaturations. Therefore, prevalence and asynchronies model on home NIV can be determine establishing the correlation between desaturation phases and respiratory events and identifying minimum tolerable leak level to keep adequate ventilation.

Official Title
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Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.

Conditions
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Neuromuscular Diseases, Obesity Hypoventilation Syndrome, Lung Disease, Restrictive

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Home non-invasive mechanical ventilation and clinical stability at least of 6 months ( no acute episode with admission on 2 months before) Mean Ventilator compliance > 4 h/ per night on screening visit Signed informed consent form previously Exclusion Criteria: Ventilation with oxygen join system.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchronies Index | Number of respiratory events registered automatically by digital diagnosis platform | One week after screening visit if the subject comply inclusion criteria. Asynchronies analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leaks | Presence or not of intencionals and unintencionals leaks recorded | One week after screening visit if the subject comply inclusion criteria. leaks analysis will be performed once (cross-sectional design) by nocturnal polygraphy on site during one night | 
| Oxygen saturation | Measure by pulsy oxymetry (%) | One week after screening visit if the subject comply inclusion criteria. Oxygen saturation analysis will be performed once by nocturnal polygraphy once (cross-sectional design) on site during one night | 
| Demographics parameters- age | age in years | screening visit | 
| Demographics parameters- sex | sex: man or woman | screening visit | 
| Pathology indication | asociated with starting mechanical ventilation | screening visit | 
| PaCO2 | PaCo2 measured by blood gas test (mmHg) < 45 | screening visit | 
| Pittsburgh Sleep Quality Index. (PSQI) | questionaire of sleep quality with ventilation. | screening visit | 
| Mode Ventilator | pressure or volume controlled modes. select the option at ventilator setings | recorded date on screening visit | 
| Interfaces | kind of mask using between the patient and ventilator. Total face mask, nasal mask, oro-nasal mask depend of patient characteristics | recorded date on screening visit | 
| Tube | Kind of tuve, simple or doublé between patient and ventilator | recorded date on screening visit | 
| Antyrebreathing system | Kind of system that avoid rebreathing CO2: acitve valve, leak controlled mask, leak controlled tube or double circuit | recorded date on screening visit | 
| Compliance ventilator | complying or not mínimum hours to recruiting (4h) | recorded date on screening visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home monitoring, Non-invasive mechanical ventilation