Lung Disease, Restrictive, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
Conditions
Keywords
home monitoring, Non-invasive mechanical ventilation
Brief summary
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
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.
Interventions
None listed
Sponsors
Sociedad Española de Neumología y Cirugía Torácica
Corporacion Parc Tauli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asynchronies Index | 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 | Number of respiratory events registered automatically by digital diagnosis platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leaks | 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 | Presence or not of intencionals and unintencionals leaks recorded |
| Oxygen saturation | 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 | Measure by pulsy oxymetry (%) |
| Demographics parameters- age | screening visit | age in years |
| Demographics parameters- sex | screening visit | sex: man or woman |
| Pathology indication | screening visit | asociated with starting mechanical ventilation |
| Compliance ventilator | recorded date on screening visit | complying or not mínimum hours to recruiting (4h) |
| Pittsburgh Sleep Quality Index. (PSQI) | screening visit | questionaire of sleep quality with ventilation. |
| Mode Ventilator | recorded date on screening visit | pressure or volume controlled modes. select the option at ventilator setings |
| Interfaces | recorded date on screening visit | kind of mask using between the patient and ventilator. Total face mask, nasal mask, oro-nasal mask depend of patient characteristics |
| Tube | recorded date on screening visit | Kind of tuve, simple or doublé between patient and ventilator |
| Antyrebreathing system | recorded date on screening visit | Kind of system that avoid rebreathing CO2: acitve valve, leak controlled mask, leak controlled tube or double circuit |
| PaCO2 | screening visit | PaCo2 measured by blood gas test (mmHg) \< 45 |
Countries
Spain
Outcome results
None listed