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

NCT03085537 | Completed

• 1 other identifier: 13/088
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuromuscular Diseases; Obesity Hypoventilation Syndrome; Lung Disease, Restrictive

Keywords

home monitoring; Non-invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• Demographics parameters- age

  screening visit

• Demographics parameters- sex

  screening visit

• Pathology indication

  screening visit

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by restrictive lung disease, neuromuscular disorders or hypoventilation-obesity with home non-invasive mechanical ventilation.

You may qualify if:

• 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

You may not qualify if:

• Ventilation with oxygen join system.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Study Sites (3)

Hospital universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Corporación Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Obesity Hypoventilation Syndrome; Lung Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Manel Lujan

  Corporation PT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lung specialist doctor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 21, 2017
• Study Start: October 1, 2016
• Primary Completion: September 30, 2018
• Study Completion: October 30, 2021
• Last Updated: March 9, 2022

Record last verified: 2017-03

Locations

ES (3)