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

Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159444
• Other study ID #: JPJ/2010
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: July 8, 2010
• Start date: February 2007
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Ligue Pulmonaire Genevoise
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ventilation

Locations

Country	Name	City	State
Switzerland	Division of Pulmonary Diseases; Geneva University Hospital	Geneva 14	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ligue Pulmonaire Genevoise

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of data downloaded from ventilator software by diagnostic category	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).	one day	No