Microbiologic Contamination of Home Non Invasive Ventilators

NCT ID: NCT03809832

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-08-20

Brief Summary

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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

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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.

Conditions

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Chronic Respiratory Failure COPD Obesity Hypoventilation Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Microbiological sampling

Intervention Type DIAGNOSTIC_TEST

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

Microbiological sampling

Intervention Type DIAGNOSTIC_TEST

An microbiological sampling of the ventilator humidifier will be performed.

Interventions

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Microbiological sampling

An microbiological sampling of the ventilator humidifier will be performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADIR Association

OTHER

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maxime Patout, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Bois-Guillaume, Normandy, France

Site Status

Countries

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France

Other Identifiers

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2018/363/OB

Identifier Type: -

Identifier Source: org_study_id

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