Change in Breathing Pattern on Non-invasive Ventilation of COPD Patients Under Home Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Copd, COPD Exacerbation

Intervention / Treatment
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* Other: Analysis of data from NIV built-in software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed COPD according to GOLD guidelines Established on home non invasive ventilation for more than 2 weeks Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control cohort<br>Patient with COPD and home NIV admitted for planned respiratory review and without any sign of exacerbation | Other: Analysis of data from NIV built-in software<br>* Analysis of breathing pattern using data obtained from NIV built-in software<br>|
| Exacerbation cohort<br>Patient with COPD and home NIV admitted for acute exacerbation of COPD | Other: Analysis of data from NIV built-in software<br>* Analysis of breathing pattern using data obtained from NIV built-in software<br>|
| Outpatient exacerbation<br>Patient with COPD and home NIV admitted for planned respiratory review and with signs of acute exacerbation of COPD but not requiring inpatient management | Other: Analysis of data from NIV built-in software<br>* Analysis of breathing pattern using data obtained from NIV built-in software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of respiratory rate at the early onset of AECOPD |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tidal volume at the early onset of AECOPD |  | 10 days | 
| Change of leaks at the early onset of 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 | 
| Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD |  | 10 days | 
| Change of the number of residual respiratory events 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 | 
| Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD |  | 10 days | 
| Correlation between the change in symptoms and in the breathing pattern under NIV |  | 10 days | 
| Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay |  | 10 days | 
| Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Non invasive ventilation, NIV, Acute exacerbation COPD, AECOPD, Telemonitoring