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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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 Summary:

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.


Sponsor: Corporacion Parc Tauli

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Leaks [ Time Frame: 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 [ Time Frame: 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 (%)
  • Demographics parameters- age [ Time Frame: screening visit ]
    age in years
  • Demographics parameters- sex [ Time Frame: screening visit ]
    sex: man or woman
  • Pathology indication [ Time Frame: screening visit ]
    asociated with starting mechanical ventilation
  • PaCO2 [ Time Frame: screening visit ]
    PaCo2 measured by blood gas test (mmHg) < 45
  • Pittsburgh Sleep Quality Index. (PSQI) [ Time Frame: screening visit ]
    questionaire of sleep quality with ventilation.
  • Mode Ventilator [ Time Frame: recorded date on screening visit ]
    pressure or volume controlled modes. select the option at ventilator setings
  • Interfaces [ Time Frame: 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 [ Time Frame: recorded date on screening visit ]
    Kind of tuve, simple or doublé between patient and ventilator
  • Antyrebreathing system [ Time Frame: recorded date on screening visit ]
    Kind of system that avoid rebreathing CO2: acitve valve, leak controlled mask, leak controlled tube or double circuit
  • Compliance ventilator [ Time Frame: recorded date on screening visit ]
    complying or not mínimum hours to recruiting (4h)


Original Secondary Outcome: Same as current

Information By: Corporacion Parc Tauli

Dates:
Date Received: March 3, 2017
Date Started: October 1, 2016
Date Completion: December 30, 2018
Last Updated: March 21, 2017
Last Verified: March 2017