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

Neuromuscular Diseases Clinical Trial

— PRE-HVNI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085537
• Other study ID #: 13/088
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Hospital Vall d´Hebron	Barcelona
Spain	Hospital universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Corporación Sanitaria Parc Tauli	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Demographics parameters- age	age in years	screening visit
Secondary	Demographics parameters- sex	sex: man or woman	screening visit
Secondary	Pathology indication	asociated with starting mechanical ventilation	screening visit
Secondary	PaCO2	PaCo2 measured by blood gas test (mmHg) < 45	screening visit
Secondary	Pittsburgh Sleep Quality Index. (PSQI)	questionaire of sleep quality with ventilation.	screening visit
Secondary	Mode Ventilator	pressure or volume controlled modes. select the option at ventilator setings	recorded date on screening visit
Secondary	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
Secondary	Tube	Kind of tuve, simple or doublé between patient and ventilator	recorded date on screening visit
Secondary	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
Secondary	Compliance ventilator	complying or not mínimum hours to recruiting (4h)	recorded date on screening visit