Microbiologic Contamination of Home Non Invasive Ventilators

NCT03809832 | Terminated FDA Device

• 1 other identifier: 2018/363/OB
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Respiratory Failure; COPD; Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of microbial contamination of non invasive ventilators humidifier

  7 days

Secondary Outcomes (5)

• Microbiological ecology in the study population

  7 days

• Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology

  7 days

• Compliance to recommendations regarding the maintenance of the humidifier

  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

Study Arms (2)

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

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

Interventions

Microbiological sampling DIAGNOSTIC_TEST

An microbiological sampling of the ventilator humidifier will be performed.

Patients with COPD; Patients with OHS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Age under 18
• Ongoing exacerbation
• Not able to consent
• Pregnant or breastfeeding

Sponsors & Collaborators

• University Hospital, Rouen: lead
• ADIR Association: collaborator

Study Sites (1)

Rouen University Hospital

Bois-Guillaume, Normandy, 76230, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Maxime Patout, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 18, 2019
• Study Start: January 21, 2019
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)