NCT03018470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

January 10, 2017

Last Update Submit

May 25, 2018

Conditions

CopdCOPD Exacerbation

Keywords

COPDNon invasive ventilationNIVAcute exacerbation COPDAECOPDTelemonitoring

Outcome Measures

Primary Outcomes (1)

  • Change of respiratory rate at the early onset of AECOPD

    10 days

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (3)

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

Exacerbation cohort

Patient with COPD and home NIV admitted for acute exacerbation of COPD

Other: Analysis of data 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

Interventions

Analysis of data from NIV built-in softwareOTHER

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

Control cohortExacerbation cohortOutpatient exacerbation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires

Rouen, Normandy, 76031, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maxime Patout, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

  • Antoine Cuvelier, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

  • Sophie Blouet

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 29, 2018

Record last verified: 2018-05

Locations

FR(1)