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

Completed

• Conditions: Ventilation

• Registration Number: NCT01159444
• Lead Sponsor: Ligue Pulmonaire Genevoise

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.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2009-10
• Status Verified: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-08
• Last Update Submitted: 2010-07-08
• Study First Posted: 2010-07-09
• Last Update Posted: 2010-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Division of Pulmonary Diseases; Geneva University Hospital; 🇨🇭 Geneva 14, Geneva, Switzerland