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CompletedNCT01159444

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
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Ligue Pulmonaire Genevoise · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2007-02-01
Primary completion
2009-10-01
Completion
2010-07-01
First posted
2010-07-09
Last updated
2010-07-09

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01159444. Inclusion in this directory is not an endorsement.

What do built-in Softwares in Home Ventilators Tell us? (NCT01159444) · Clinical Trials Directory