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Microbiologic Contamination of Home Non Invasive Ventilators (MiCONIV)

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ClinicalTrials.gov Identifier: NCT03809832
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
ADIR Association
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment
Chronic Respiratory Failure COPD Obesity Hypoventilation Syndrome Diagnostic Test: Microbiological sampling

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
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiologic Contamination of Home Non Invasive Ventilators
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 30, 2019

Group/Cohort Intervention/treatment
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
Diagnostic Test: Microbiological sampling
An microbiological sampling of the ventilator humidifier will be performed.

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
Diagnostic Test: Microbiological sampling
An microbiological sampling of the ventilator humidifier will be performed.




Primary Outcome Measures :
  1. Prevalence of microbial contamination of non invasive ventilators humidifier [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Microbiological ecology in the study population [ Time Frame: 7 days ]
    The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)

  2. Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology [ Time Frame: 7 days ]
    We will compare the microbiological ecology of patients in the COPD and in the Obesity hypoventilation group (percentage of each pathogen in each group)

  3. Compliance to recommendations regarding the maintenance of the humidifier [ Time Frame: 7 days ]

    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)

  4. Correlation between compliance to maintenance recommendations and contamination rate [ Time Frame: 7 days ]
  5. Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier [ Time Frame: 12 months ]


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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
Study Population
Patients established on long term home non-invasive ventilation admitted for a scheduled review.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809832


Contacts
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Contact: Maxime Patout, MD 0232889000 maxime.patout@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Bois-Guillaume, Normandy, France, 76230
Contact: Maxime Patout, MD    0232889000    maxime.patout@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
ADIR Association
Investigators
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Principal Investigator: Maxime Patout, MD Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03809832     History of Changes
Other Study ID Numbers: 2018/363/OB
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoventilation
Obesity Hypoventilation Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Obesity
Overnutrition
Nutrition Disorders