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

Copd Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018470
• Other study ID #: 2017/015/SC
• Status: Completed
• Start date: January 2017
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed COPD according to GOLD guidelines

• Established on home non invasive ventilation for more than 2 weeks

Exclusion Criteria:

Related Conditions & MeSH terms

• Copd
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Analysis of data from NIV built-in software
Analysis of breathing pattern using data obtained from NIV built-in software

Locations

Country	Name	City	State
France	Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires	Rouen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of respiratory rate at the early onset of AECOPD		10 days
Secondary	Change of tidal volume at the early onset of AECOPD		10 days
Secondary	Change of leaks at the early onset of AECOPD		10 days
Secondary	Change of length of use of NIV at the early onset of AECOPD		10 days
Secondary	Change of number of breaks during the use of NIV at the early onset of AECOPD		10 days
Secondary	Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD		10 days
Secondary	Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD		10 days
Secondary	Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD		10 days
Secondary	Change of the inspiratory time during the use of NIV at the early onset of AECOPD		10 days
Secondary	Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD		10 days
Secondary	Correlation between the change in symptoms and in the breathing pattern under NIV		10 days
Secondary	Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay		10 days
Secondary	Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD		10 days