Microbiologic Contamination of Home Non Invasive Ventilators

COPD Clinical Trial

— MiCONIV  

Official title:

Microbiologic Contamination of Home Non Invasive Ventilators

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03809832
• Other study ID #: 2018/363/OB
• Status: Terminated
• Start date: January 21, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: January 2019
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• COPD
• Hypoventilation
• Obesity Hypoventilation Syndrome
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Bois-Guillaume	Normandy

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of microbial contamination of non invasive ventilators humidifier		7 days
Secondary	Microbiological ecology in the study population	The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)	7 days
Secondary	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
Secondary	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
Secondary	Correlation between compliance to maintenance recommendations and contamination rate		7 days
Secondary	Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier		12 months