Microbiologic Contamination of Home Non Invasive Ventilators (MiCONIV)

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.

Study Overview

• Status: Terminated
• Conditions: COPD; Chronic Respiratory Failure; Obesity Hypoventilation Syndrome
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• France
  • Normandy
    • Bois-Guillaume, Normandy, France, 76230
      • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of microbial contamination of non invasive ventilators humidifier	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological ecology in the study population	The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)	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)	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)	7 days
Correlation between compliance to maintenance recommendations and contamination rate		7 days
Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier		12 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: ADIR Association
• Investigators: Principal Investigator: Maxime Patout, MD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: 2018/363/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No