MiCONIV: Microbiologic Contamination of Home Non Invasive Ventilators

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03809832
• Collaborator: ADIR Association (Other)
• Enrollment: 54
• Location: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 54 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Microbiologic Contamination of Home Non Invasive Ventilators
• Actual Study Start Date: Jan 21, 2019
• Actual Primary Completion Date: Aug 20, 2019
• Actual Study Completion Date: Aug 20, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Prevalence of microbial contamination of non invasive ventilators humidifier [7 days]

Secondary Outcome Measures

1. Microbiological ecology in the study population [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 [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 [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 [7 days]

5. Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Bois-Guillaume	Normandy	France	76230

Sponsors and Collaborators

• University Hospital, Rouen
• ADIR Association

Investigators

• Principal Investigator: Maxime Patout, MD, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT03809832
• Other Study ID Numbers: 2018/363/OB
• First Posted: Jan 18, 2019
• Last Update Posted: Sep 4, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome

Study Results

No Results Posted as of Sep 4, 2019