Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-07-06 @ 2:05 AM
Study NCT ID:
NCT03809832
Status:
TERMINATED
Last Update Posted:
2019-09-04
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiologic Contamination of Home Non Invasive Ventilators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Preliminary results providing sufficient data', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-02', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of microbial contamination of non invasive ventilators humidifier', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Microbiological ecology in the study population', 'timeFrame': '7 days', 'description': 'The microbiological ecology of the ventilator humidifier will be describes (percentage of each pathogen)'}, {'measure': 'Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology', 'timeFrame': '7 days', 'description': 'We will compare the microbiological ecology of patients in the COPD and in the Obesity hypoventilation group (percentage of each pathogen in each group)'}, {'measure': 'Compliance to recommendations regarding the maintenance of the humidifier', 'timeFrame': '7 days', 'description': 'Compliance to recommendations will be assessed by a questionnaire containing 7 items regarding how the humidifier is maintained by the patient :\n\n* Who is maintaining the ventilator (descriptive)\n* At which frequency are you changing the water (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)\n* What type of water are you using (descriptive)\n* At which frequency are you cleaning the mask (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)\n* At which frequency are you cleaning the humidifier (Everyday (adequate), every other-day (almost adequate), every week (inadequate), more than weekly (inadequate)\n* How are you cleaning the humidifier? Water (inadequate), soap (adequate), dishawashing liquid (inadequate)'}, {'measure': 'Correlation between compliance to maintenance recommendations and contamination rate', 'timeFrame': '7 days'}, {'measure': 'Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Respiratory Failure', 'COPD', 'Obesity Hypoventilation Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nThe aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.', 'detailedDescription': 'The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.\n\nNo study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients established on long term home non-invasive ventilation admitted for a scheduled review.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient established on home non invasive ventilation for more than 6 months\n* With a compliance \\>4hours/day\n* Who brought their ventilator for the assessment\n* Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)\n* Who consent\n* With an age \\> 18 years\n\nExclusion Criteria:\n\n* Age under 18\n* Ongoing exacerbation\n* Not able to consent\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03809832', 'acronym': 'MiCONIV', 'briefTitle': 'Microbiologic Contamination of Home Non Invasive Ventilators', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Microbiologic Contamination of Home Non Invasive Ventilators', 'orgStudyIdInfo': {'id': '2018/363/OB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COPD', 'description': 'Patients established on home non-invasive ventilation for COPD admitted for respiratory review will have a microbiological sampling of the ventilator humidifier', 'interventionNames': ['Diagnostic Test: Microbiological sampling']}, {'label': 'Patients with OHS', 'description': 'Patients established on home non-invasive ventilation for obesity hypoventilation syndrome admitted for respiratory review will have a microbiological sampling of the ventilator humidifier', 'interventionNames': ['Diagnostic Test: Microbiological sampling']}], 'interventions': [{'name': 'Microbiological sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'An microbiological sampling of the ventilator humidifier will be performed.', 'armGroupLabels': ['Patients with COPD', 'Patients with OHS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76230', 'city': 'Bois-Guillaume', 'state': 'Normandy', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}], 'overallOfficials': [{'name': 'Maxime Patout, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'collaborators': [{'name': 'ADIR Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}