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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

Tracking Information
First Submitted Date January 7, 2019
First Posted Date January 18, 2019
Last Update Posted Date August 5, 2019
Actual Study Start Date February 2, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
Prevalence of microbial contamination of non invasive ventilators humidifier [ Time Frame: 7 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03809832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 17, 2019)
  • Microbiological ecology in the study population [ Time Frame: 7 days ]
    The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)
  • 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)
  • 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)
  • 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 ]
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Chronic Respiratory Failure
  • COPD
  • Obesity Hypoventilation Syndrome
Intervention Diagnostic Test: Microbiological sampling
An microbiological sampling of the ventilator humidifier will be performed.
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Diagnostic Test: Microbiological sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 17, 2019)
125
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maxime Patout, MD 0232889000 maxime.patout@chu-rouen.fr
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
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Rouen
Study Sponsor University Hospital, Rouen
Collaborators ADIR Association
Investigators
Principal Investigator: Maxime Patout, MD Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date January 2019