Microbiologic Contamination of Home Non Invasive Ventilators

Terminated

• Conditions: COPD; Obesity Hypoventilation Syndrome; Chronic Respiratory Failure
• Interventions: Diagnostic Test: Microbiological sampling

• Registration Number: NCT03809832
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-01-21
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with COPD	Microbiological sampling	Patients established on home non-invasive ventilation for COPD admitted for respiratory review will have a microbiological sampling of the ventilator humidifier
Patients with OHS	Microbiological sampling	Patients established on home non-invasive ventilation for obesity hypoventilation syndrome admitted for respiratory review will have a microbiological sampling of the ventilator humidifier

Primary Outcome Measures

Name	Time	Method
Prevalence of microbial contamination of non invasive ventilators humidifier	7 days

Secondary Outcome Measures

Name	Time	Method
Microbiological ecology in the study population	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	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	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	7 days
Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier	12 months

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Bois-Guillaume, Normandy, France