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

What do built-in Softwares in Home Ventilators Tell us? An Observational Study of 150 Patients on Home Ventilation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01159444

Enrollment

150

Registered

2010-07-09

Start date

2007-02-28

Completion date

2010-07-31

Last updated

2010-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

Keywords

noninvasive ventilation, ventilator software, ventilator settings, domiciliary ventilation

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- All patients with home noninvasive ventilation with bi-level positive pressure home ventilators with integrated software

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Analysis of data downloaded from ventilator software by diagnostic category	one day	Analysis of data provided by ventilator software during elective home visits by specialized nurses in stable patients under home ventilation. Data includes all ventilator parameters, leaks, tidal volume, total ventilation, respiratory rate, % of cycles triggered by the patient, apnea-hypopnea index, and compliance. Age, gender, BMI, spirometry, type of mask and pulse oximetry are also available. The analysis will describe ventilatory patterns and ventilator settings as a function of diagnosis, as well as factors related to importance of leaks (age, interface, ventilator settings).

Countries

Switzerland

Outcome results