NCT01159444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

2.7 years

First QC Date

July 7, 2010

Last Update Submit

July 8, 2010

Conditions

Ventilation

Keywords

noninvasive ventilationventilator softwareventilator settingsdomiciliary ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • Hospitalisation or acute exacerbation;
  • Ventilation with a device not equipped with built-in software,
  • Ventilation with servo-assisted ventilator
  • Invasive ventilation (tracheostomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Pulmonary Diseases; Geneva University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Paul Janssens, Professor

    Division of Pulmonary Diseases; Geneva University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 9, 2010

Study Start

February 1, 2007

Primary Completion

October 1, 2009

Study Completion

July 1, 2010

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

CH(1)