Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromuscular Diseases
- Sponsor
- Corporacion Parc Tauli
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Asynchronies Index
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Manel Lujan-Torne
Lung specialist doctor
Corporacion Parc Tauli
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Asynchronies Index
Time Frame: 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 Outcomes
- Demographics parameters- age(screening visit)
- Demographics parameters- sex(screening visit)
- PaCO2(screening visit)
- Pittsburgh Sleep Quality Index. (PSQI)(screening visit)
- Mode Ventilator(recorded date on screening visit)
- Interfaces(recorded date on screening visit)
- Tube(recorded date on screening visit)
- Antyrebreathing system(recorded date on screening visit)
- 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)
- 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)
- Pathology indication(screening visit)
- Compliance ventilator(recorded date on screening visit)