Clinical trial NCT03018470: Change in Breathing Pattern on Non-invasive Ventilation of COPD Patients Under Home Mechanical Ventilation
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
COPD Exacerbation
Keywords: COPD
Non invasive ventilation
NIV
Acute exacerbation COPD
AECOPD
Telemonitoring
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted to Rouen Respiratory unit with established COPD and home non invasive ventilation

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change of respiratory rate at the early onset of AECOPD
timeFrame: 10 days
Secondary outcomes:
measure: Change of tidal volume at the early onset of AECOPD
timeFrame: 10 days
measure: Change of leaks at the early onset of AECOPD
timeFrame: 10 days
measure: Change of length of use of NIV at the early onset of AECOPD
timeFrame: 10 days
measure: Change of number of breaks during the use of NIV at the early onset of AECOPD
timeFrame: 10 days
measure: Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD
timeFrame: 10 days
measure: Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD
timeFrame: 10 days
measure: Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD
timeFrame: 10 days
measure: Change of the inspiratory time during the use of NIV at the early onset of AECOPD
timeFrame: 10 days
measure: Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD
timeFrame: 10 days
measure: Correlation between the change in symptoms and in the breathing pattern under NIV
timeFrame: 10 days
measure: Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay
timeFrame: 10 days
measure: Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD
timeFrame: 10 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires
state: Normandie
Study officials:
affiliation: University Hospital, Rouen
name: Maxime Patout, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Antoine Cuvelier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Sophie Blouet
role: PRINCIPAL_INVESTIGATOR
References: