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Completed

NCT Number: NCT03085537

Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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 (%)

  3. Demographics parameters- age

    Time frame: screening visit

    age in years

  4. Demographics parameters- sex

    Time frame: screening visit

    sex: man or woman

  5. Pathology indication

    Time frame: screening visit

    asociated with starting mechanical ventilation

  6. PaCO2

    Time frame: screening visit

    PaCo2 measured by blood gas test (mmHg) < 45

  7. Pittsburgh Sleep Quality Index. (PSQI)

    Time frame: screening visit

    questionaire of sleep quality with ventilation.

  8. Mode Ventilator

    Time frame: recorded date on screening visit

    pressure or volume controlled modes. select the option at ventilator setings

  9. 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

  10. Tube

    Time frame: recorded date on screening visit

    Kind of tuve, simple or doublé between patient and ventilator

  11. 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

  12. Compliance ventilator

    Time frame: recorded date on screening visit

    complying or not mínimum hours to recruiting (4h)

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study title

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

Acronym: PRE-HVNI

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Mar 21, 2017
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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