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.
Condition or disease | Intervention/treatment |
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Chronic Respiratory Failure COPD Obesity Hypoventilation Syndrome | Diagnostic Test: Microbiological sampling |
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 Type : | Observational |
Actual Enrollment : | 54 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Microbiologic Contamination of Home Non Invasive Ventilators |
Actual Study Start Date : | January 21, 2019 |
Actual Primary Completion Date : | August 20, 2019 |
Actual Study Completion Date : | August 20, 2019 |
Group/Cohort | Intervention/treatment |
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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
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Diagnostic Test: Microbiological sampling
An microbiological sampling of the ventilator humidifier will be performed.
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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
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Diagnostic Test: Microbiological sampling
An microbiological sampling of the ventilator humidifier will be performed.
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Compliance to recommendations will be assessed by a questionnaire containing 7 items regarding how the humidifier is maintained by the patient :
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
France | |
Rouen University Hospital | |
Bois-Guillaume, Normandy, France, 76230 |
Principal Investigator: | Maxime Patout, MD | Rouen University Hospital |
Tracking Information | |||||||
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First Submitted Date | January 7, 2019 | ||||||
First Posted Date | January 18, 2019 | ||||||
Last Update Posted Date | September 4, 2019 | ||||||
Actual Study Start Date | January 21, 2019 | ||||||
Actual Primary Completion Date | August 20, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Prevalence of microbial contamination of non invasive ventilators humidifier [ Time Frame: 7 days ] | ||||||
Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Microbiologic Contamination of Home Non Invasive Ventilators | ||||||
Official Title | Microbiologic Contamination of Home Non Invasive Ventilators | ||||||
Brief 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. The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs. |
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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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Patients established on long term home non-invasive ventilation admitted for a scheduled review. | ||||||
Condition |
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Intervention | Diagnostic Test: Microbiological sampling
An microbiological sampling of the ventilator humidifier will be performed.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Terminated | ||||||
Actual Enrollment |
54 | ||||||
Original Estimated Enrollment |
125 | ||||||
Actual Study Completion Date | August 20, 2019 | ||||||
Actual Primary Completion Date | August 20, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | France | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03809832 | ||||||
Other Study ID Numbers | 2018/363/OB | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University Hospital, Rouen | ||||||
Study Sponsor | University Hospital, Rouen | ||||||
Collaborators | ADIR Association | ||||||
Investigators |
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PRS Account | University Hospital, Rouen | ||||||
Verification Date | January 2019 |