CopdNCT03018470
Change in Breathing Pattern on Non-invasive Ventilation of COPD Patients Under Home Mechanical Ventilation
An observational study of Copd and COPD Exacerbation, run by University Hospital, Rouen at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, COPD Exacerbation
- What is being tested?
- Analysis of data from NIV built-in software
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients admitted to Rouen Respiratory unit with established COPD and home non invasive ventilation
Who may be able to join
- Diagnosed COPD according to GOLD guidelines
- Established on home non invasive ventilation for more than 2 weeks
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires
Rouen, Normandy, 76031
About this study
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.
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.
- Conditions
- Copd, COPD Exacerbation
- Being tested
- Analysis of data from NIV built-in software
- Keywords
- COPD, Non invasive ventilation, NIV, Acute exacerbation COPD, AECOPD, Telemonitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of data from NIV built-in softwareOther
Analysis of breathing pattern using data obtained from NIV built-in software
| Study group | Role | What they receive |
|---|---|---|
| Control cohort | Patient with COPD and home NIV admitted for planned respiratory review and without any sign of exacerbation Receives: Other: Analysis of data from NIV built-in software | |
| Exacerbation cohort | Patient with COPD and home NIV admitted for acute exacerbation of COPD Receives: 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 Receives: Other: Analysis of data from NIV built-in software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of respiratory rate at the early onset of AECOPD
Measured: 10 days
Secondary outcomes (12)
Change of tidal volume at the early onset of AECOPD
Measured: 10 days
Change of leaks at the early onset of AECOPD
Measured: 10 days
Change of length of use of NIV at the early onset of AECOPD
Measured: 10 days
Change of number of breaks during the use of NIV at the early onset of AECOPD
Measured: 10 days
Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD
Measured: 10 days
Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD
Measured: 10 days
Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD
Measured: 10 days
Change of the inspiratory time during the use of NIV at the early onset of AECOPD
Measured: 10 days
Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD
Measured: 10 days
Correlation between the change in symptoms and in the breathing pattern under NIV
Measured: 10 days
Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay
Measured: 10 days
Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Patout, MD, Principal investigator, University Hospital, RouenAntoine Cuvelier, MD, PhD, Principal investigator, University Hospital, RouenSophie Blouet, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018470
- Sponsor's protocol ID
- 2017/015/SC
- Status last verified
- May 2018
- First submitted
- 10 Jan 2017
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03018470
- Acronym / sponsor ID
- 2017/015/SC
- Conditions
- Copd, COPD Exacerbation
- Keywords
- COPD, Non invasive ventilation, NIV, Acute exacerbation COPD, AECOPD, Telemonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control cohort | – | Other: Analysis of data from NIV built-in softwarePatient with COPD and home NIV admitted for planned respiratory review and without any sign of exacerbation |
| Exacerbation cohort | – | Other: Analysis of data from NIV built-in softwarePatient with COPD and home NIV admitted for acute exacerbation of COPD |
| Outpatient exacerbation | – | Other: Analysis of data from NIV built-in softwarePatient with COPD and home NIV admitted for planned respiratory review and with signs of acute exacerbation of COPD but not requiring inpatient management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to Rouen Respiratory unit with established COPD and home non invasive ventilation
Key inclusion criteria (2 listed)
- Diagnosed COPD according to GOLD guidelines
- Established on home non invasive ventilation for more than 2 weeks
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of data from NIV built-in softwareAnalysis of breathing pattern using data obtained from NIV built-in software | Other | Control cohort, Exacerbation cohort, Outpatient exacerbation |
Primary outcome
Change of respiratory rate at the early onset of AECOPD
Time frame: 10 days
12 secondary outcomes
Change of tidal volume at the early onset of AECOPD
Time frame: 10 days
Change of leaks at the early onset of AECOPD
Time frame: 10 days
Change of length of use of NIV at the early onset of AECOPD
Time frame: 10 days
Change of number of breaks during the use of NIV at the early onset of AECOPD
Time frame: 10 days
Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD
Time frame: 10 days
Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD
Time frame: 10 days
Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD
Time frame: 10 days
Change of the inspiratory time during the use of NIV at the early onset of AECOPD
Time frame: 10 days
Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD
Time frame: 10 days
Correlation between the change in symptoms and in the breathing pattern under NIV
Time frame: 10 days
Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay
Time frame: 10 days
Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Patout, MD principal investigator
University Hospital, Rouen
Antoine Cuvelier, MD, PhD principal investigator
University Hospital, Rouen
Sophie Blouet principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and COPD Exacerbation, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of respiratory rate at the early onset of AECOPD (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.