Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform (PRE-HVNI)

March 8, 2022 updated by: Manel Lujan-Torne, Corporacion Parc Tauli

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08035
        • Hospital Vall D´Hebron
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Sabadell, Barcelona, Spain, 08208
        • Corporacion Sanitaria Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manel Lujan, Corporation PT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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