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Completed

NCT Number: NCT03018470

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

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.

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Key information

Conditions

COPD COPD Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires

Rouen, Normandy, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Analysis of data from NIV built-in software

Other

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

Primary outcomes

  1. Change of respiratory rate at the early onset of AECOPD

    Time frame: 10 days

Secondary outcomes

  1. Change of tidal volume at the early onset of AECOPD

    Time frame: 10 days

  2. Change of leaks at the early onset of AECOPD

    Time frame: 10 days

  3. Change of length of use of NIV at the early onset of AECOPD

    Time frame: 10 days

  4. Change of number of breaks during the use of NIV at the early onset of AECOPD

    Time frame: 10 days

  5. Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD

    Time frame: 10 days

  6. Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD

    Time frame: 10 days

  7. Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD

    Time frame: 10 days

  8. Change of the inspiratory time during the use of NIV at the early onset of AECOPD

    Time frame: 10 days

  9. Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD

    Time frame: 10 days

  10. Correlation between the change in symptoms and in the breathing pattern under NIV

    Time frame: 10 days

  11. Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay

    Time frame: 10 days

  12. Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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