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

July 8, 2010 updated by: Ligue Pulmonaire Genevoise

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Geneva
      • Geneva 14, Geneva, Switzerland, 1211
        • Division of Pulmonary Diseases; Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of data downloaded from ventilator software by diagnostic category
Time Frame: 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).
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ligue Pulmonaire Genevoise

Investigators

  • Principal Investigator: Jean-Paul Janssens, Professor, Division of Pulmonary Diseases; Geneva University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 9, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JPJ/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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