What do built-in Softwares in Home Ventilators Tell us?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-07-31

Brief Summary

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Home bi-level positive pressure ventilators are equipped with built-in softwares which measure and record specific items such as tidal volume, total ventilation, leaks, respiratory rate, cycles triggered by the patient. These items have not to date been described in a large group of patients under home mechanical ventilation.

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Detailed Description

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Observational study of patients under home positive pressure mechanical ventilation, in a stable condition.

Data recorded by ventilator software is downloaded by specialized nurses during elective home visits, as well as spirometry, results of recent pulse oximetry, ventilator settings, diagnosis, and basic anthropometric data.

Items recorded by ventilator software are: tidal volume, total ventilation, apnea and hypopnea index, leaks, percentage of inspiratory cycles triggered by ventilator, spontaneous and back-up respiratory rates.

Results are reported by diagnostic group. Statistical analysis (univariate and multivariate) aims to determine which variables are related to unintentional leaks, and whether ventilator settings differ significantly between diagnostic groups.

Conditions

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Ventilation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

* Hospitalisation or acute exacerbation;
* Ventilation with a device not equipped with built-in software,
* Ventilation with servo-assisted ventilator
* Invasive ventilation (tracheostomy)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No