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

Completed

• Conditions: COPD Exacerbation; Copd
• Interventions: Other: Analysis of data from NIV built-in software

• Registration Number: NCT03018470
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatient exacerbation	Analysis of data from NIV built-in software	Patient with COPD and home NIV admitted for planned respiratory review and with signs of acute exacerbation of COPD but not requiring inpatient management
Exacerbation cohort	Analysis of data from NIV built-in software	Patient with COPD and home NIV admitted for acute exacerbation of COPD
Control cohort	Analysis of data from NIV built-in software	Patient with COPD and home NIV admitted for planned respiratory review and without any sign of exacerbation

Primary Outcome Measures

Name	Time	Method
Change of respiratory rate at the early onset of AECOPD	10 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires; 🇫🇷 Rouen, Normandie, France