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

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.

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.

Study Overview

• Status: Completed
• Conditions: Copd; COPD Exacerbation
• Intervention / Treatment: Other: Analysis of data from NIV built-in software

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Normandie
    • Rouen, Normandie, France, 76031
      • Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted to Rouen Respiratory unit with established COPD and home non invasive ventilation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control cohort; 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; Analysis of breathing pattern using data obtained from NIV built-in software
Exacerbation cohort; Patient with COPD and home NIV admitted for acute exacerbation of COPD	Other: Analysis of data from NIV built-in software; Analysis of breathing pattern using data obtained from NIV built-in software
Outpatient exacerbation; 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; Analysis of breathing pattern using data obtained from NIV built-in software

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Maxime Patout, MD, University Hospital, Rouen; Principal Investigator: Antoine CUVELIER, MD, PhD, University Hospital, Rouen; Principal Investigator: Sophie Blouet, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: COPD; Telemonitoring; AECOPD; NIV; Non invasive ventilation; Acute exacerbation COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2017/015/SC