Chronic Respiratory FailureMiCONIVNCT03809832
Microbiologic Contamination of Home Non Invasive Ventilators
An observational study of Chronic Respiratory Failure and COPD, run by University Hospital, Rouen at 1 site in France.
Trial summary
Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure, COPD, Obesity Hypoventilation Syndrome
- What is being tested?
- Microbiological sampling
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 20 Aug 2019
- 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: Patients established on long term home non-invasive ventilation admitted for a scheduled review.
Who may be able to join
- Patient established on home non invasive ventilation for more than 6 months
- With a compliance >4hours/day
- Who brought their ventilator for the assessment
- Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)
- Who consent
- With an age > 18 years
Who cannot join
- Age under 18
- Ongoing exacerbation
- Not able to consent
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.
The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.
Read the detailed description
The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.
No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.
- Being tested
- Microbiological sampling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological samplingDiagnostic test
An microbiological sampling of the ventilator humidifier will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Patients established on home non-invasive ventilation for COPD admitted for respiratory review will have a microbiological sampling of the ventilator humidifier Receives: Diagnostic Test: Microbiological sampling | |
| Patients with OHS | Patients established on home non-invasive ventilation for obesity hypoventilation syndrome admitted for respiratory review will have a microbiological sampling of the ventilator humidifier Receives: Diagnostic Test: Microbiological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of microbial contamination of non invasive ventilators humidifier
Measured: 7 days
Secondary outcomes (5)
Microbiological ecology in the study population
The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)
Measured: 7 days
Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology
We will compare the microbiological ecology of patients in the COPD and in the Obesity hypoventilation group (percentage of each pathogen in each group)
Measured: 7 days
Compliance to recommendations regarding the maintenance of the humidifier
Compliance to recommendations will be assessed by a questionnaire containing 7 items regarding how the humidifier is maintained by the patient :
- Who is maintaining the ventilator (descriptive)
- At which frequency are you changing the water (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)
- What type of water are you using (descriptive)
- At which frequency are you cleaning the mask (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)
- At which frequency are you cleaning the humidifier (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)
- How are you cleaning the humidifier? Water (inadequate), soap (adequate), dishawashing liquid (inadequate)
Measured: 7 days
Correlation between compliance to maintenance recommendations and contamination rate
Measured: 7 days
Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start21 Jan 2019
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Why it stopped: Preliminary results providing sufficient data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR Association
- Responsible party
- Sponsor
- Investigators
- Maxime Patout, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809832
- Sponsor's protocol ID
- 2018/363/OB
- Acronym
- MiCONIV
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiologic Contamination of Home Non Invasive Ventilators
- ClinicalTrials.gov ID
- NCT03809832
- Acronym / sponsor ID
- MiCONIV / 2018/363/OB
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary results providing sufficient data
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- ADIR Association
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- 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.
Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.
The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.
Detailed description
The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.
No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | Diagnostic Test: Microbiological samplingPatients established on home non-invasive ventilation for COPD admitted for respiratory review will have a microbiological sampling of the ventilator humidifier |
| Patients with OHS | – | Diagnostic Test: Microbiological samplingPatients established on home non-invasive ventilation for obesity hypoventilation syndrome admitted for respiratory review will have a microbiological sampling of the ventilator humidifier |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients established on long term home non-invasive ventilation admitted for a scheduled review.
Key inclusion criteria (6 listed)
- Patient established on home non invasive ventilation for more than 6 months
- With a compliance >4hours/day
- Who brought their ventilator for the assessment
- Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)
- Who consent
Key exclusion criteria (4 listed)
- Age under 18
- Ongoing exacerbation
- Not able to consent
- Pregnant or breastfeeding
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 |
|---|---|---|
| Microbiological samplingAn microbiological sampling of the ventilator humidifier will be performed. | Diagnostic test | Patients with COPD, Patients with OHS |
Primary outcome
Prevalence of microbial contamination of non invasive ventilators humidifier
Time frame: 7 days
5 secondary outcomes
Microbiological ecology in the study population
Time frame: 7 days
Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology
Time frame: 7 days
Compliance to recommendations regarding the maintenance of the humidifier
Time frame: 7 days
Correlation between compliance to maintenance recommendations and contamination rate
Time frame: 7 days
Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Preliminary results providing sufficient data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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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
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 Chronic Respiratory Failure and COPD, 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Sep 2019. 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 was stopped early (reason given: Preliminary results providing sufficient data). Results are not available in the source record.
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?
Prevalence of microbial contamination of non invasive ventilators humidifier (time frame: 7 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 4 Sep 2019.