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

Completed

• Conditions: Lung Disease, Restrictive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome

• Registration Number: NCT03085537
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study Start: 2016-10-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-21
• Primary Completion: 2018-09-30
• Study Completion: 2021-10-30
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Demographics parameters- age	screening visit	age in years
Demographics parameters- sex	screening visit	sex: man or woman
PaCO2	screening visit	PaCo2 measured by blood gas test (mmHg) \< 45
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
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 (%)
Pathology indication	screening visit	asociated with starting mechanical ventilation
Compliance ventilator	recorded date on screening visit	complying or not mínimum hours to recruiting (4h)

Trial Locations

Locations (3)

Hospital universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Corporación Sanitaria Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Vall d´Hebron; 🇪🇸 Barcelona, Spain