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Microbiologic Contamination of Home Non Invasive Ventilators

Microbiologic Contamination of Home Non Invasive Ventilators

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03809832
Acronym
MiCONIV
Enrollment
54
Registered
2019-01-18
Start date
2019-01-21
Completion date
2019-08-20
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure, COPD, Obesity Hypoventilation Syndrome

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.

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.

Interventions

An microbiological sampling of the ventilator humidifier will be performed.

Sponsors

ADIR Association
CollaboratorOTHER
University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age under 18 * Ongoing exacerbation * Not able to consent * Pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Prevalence of microbial contamination of non invasive ventilators humidifier7 days

Secondary

MeasureTime frameDescription
Microbiological ecology in the study population7 daysThe microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)
Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology7 daysWe will compare the microbiological ecology of patients in the COPD and in the Obesity hypoventilation group (percentage of each pathogen in each group)
Compliance to recommendations regarding the maintenance of the humidifier7 daysCompliance 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)
Correlation between compliance to maintenance recommendations and contamination rate7 days
Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026