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

This study has been completed.
Sponsor:
Information provided by:
Ligue Pulmonaire Genevoise
ClinicalTrials.gov Identifier:
NCT01159444
First received: July 7, 2010
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition
Ventilation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: What do built-in Softwares in Home Ventilators Tell us? An Observational Study of 150 Patients on Home Ventilation

Further study details as provided by Ligue Pulmonaire Genevoise:

Primary Outcome Measures:
  • Analysis of data downloaded from ventilator software by diagnostic category [ Time Frame: one day ] [ Designated as safety issue: No ]
    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).


Enrollment: 150
Study Start Date: February 2007
Study Completion Date: July 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated for at least 3 months in the Geneva Canton Area, followed by the Division of Pulmonary Diseases of Geneva University Hospital, under home ventilation with bi-level positive pressure home ventilators with integrated software for data recording, in stable clinical condition

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159444

Locations
Switzerland
Division of Pulmonary Diseases; Geneva University Hospital
Geneva 14, Geneva, Switzerland, 1211
Sponsors and Collaborators
Ligue Pulmonaire Genevoise
Investigators
Principal Investigator: Jean-Paul Janssens, Professor Division of Pulmonary Diseases; Geneva University Hospital
  More Information

No publications provided

Responsible Party: Janssens, Jean-Paul, Professor, Division of Pulmonary Diseases/ Geneva University Hospital
ClinicalTrials.gov Identifier: NCT01159444     History of Changes
Other Study ID Numbers: JPJ/2010
Study First Received: July 7, 2010
Last Updated: July 8, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by Ligue Pulmonaire Genevoise:
noninvasive ventilation
ventilator software
ventilator settings
domiciliary ventilation

ClinicalTrials.gov processed this record on May 16, 2013