Usefulness of built-in Non-invasive Ventilator Software to Detect the Change in the Breathing Pattern of COPD Patients Under Home Mechanical Ventilation Before an Admission for Acute Exacerbation of COPD.

University Hospital, Rouen1 site in 1 country80 target enrollmentJanuary 2017

ConditionsCopd COPD Exacerbation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Copd
Sponsor: University Hospital, Rouen
Enrollment: 80
Locations: 1
Primary Endpoint: Change of respiratory rate at the early onset of AECOPD
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients. Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that have to be monitored are not well defined.

Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in software which are recording the breathing pattern of patients when used. The aim of this study is to identify ventilation parameters that are modified at the early stage of an AECOPD.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

August 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Rouen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosed COPD according to GOLD guidelines
•Established on home non invasive ventilation for more than 2 weeks

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change of respiratory rate at the early onset of AECOPD

Time Frame: 10 days

Secondary Outcomes

Change of tidal volume at the early onset of AECOPD(10 days)
Correlation between the change in symptoms and in the breathing pattern under NIV(10 days)
Change of leaks at the early onset of AECOPD(10 days)
Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD(10 days)
Change of the inspiratory time during the use of NIV at the early onset of AECOPD(10 days)
Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD(10 days)
Change of length of use of NIV at the early onset of AECOPD(10 days)
Change of number of breaks during the use of NIV at the early onset of AECOPD(10 days)
Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD(10 days)
Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD(10 days)
Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD(10 days)
Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay(10 days)