Clinical trial NCT03085537: Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform
Official title: Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Pressure and Flow-time Signals Analysis Integrated on Digital Diagnosis Platform.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Obesity Hypoventilation Syndrome
Lung Disease, Restrictive
Keywords: home monitoring
Non-invasive mechanical ventilation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2017-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by restrictive lung disease, neuromuscular disorders or hypoventilation-obesity with home 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.

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.

Primary outcomes:
measure: Asynchronies Index
timeFrame: 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 outcomes:
measure: Leaks
timeFrame: 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
measure: Oxygen saturation
timeFrame: 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: Demographics parameters- age
timeFrame: screening visit
measure: Demographics parameters- sex
timeFrame: screening visit
measure: Pathology indication
timeFrame: screening visit
measure: PaCO2
timeFrame: screening visit
measure: Pittsburgh Sleep Quality Index. (PSQI)
timeFrame: screening visit
measure: Mode Ventilator
timeFrame: recorded date on screening visit
measure: Interfaces
timeFrame: recorded date on screening visit
measure: Tube
timeFrame: recorded date on screening visit
measure: Antyrebreathing system
timeFrame: recorded date on screening visit
measure: Compliance ventilator
timeFrame: recorded date on screening visit
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital universitari de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Corporación Sanitaria Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
Study officials:
affiliation: Corporation PT
name: Manel Lujan
role: PRINCIPAL_INVESTIGATOR
References: