Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02400294
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014099', 'term': 'Toothbrushing'}], 'ancestors': [{'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2030}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nosocomial ventilator associated pneumonia', 'timeFrame': 'at Day-28', 'description': 'Presence of at least two signs (body fever greater than 38°C; leukocytosis greater than 12000/ml or leukopenia below 4000/ml, purulent pulmonary secretions) associated with the appearance of a new infiltrate or modification of an existing infiltrate on chest-X-ray. Confirmation by a lower respiratory tract sample using a quantitative culture with a predefined positive threshold. Hospital-acquired pneumonia was defined as a pneumonia that occurs at least 48 hours after admission, which was not incubating at time of admission (Am J Respir Crit Care Med 2005; 171, 388-416).'}], 'secondaryOutcomes': [{'measure': 'Tracheobronchitis', 'timeFrame': 'at Day-28', 'description': 'Association of at least two signs (fever above 38.0°C, Leucocytosis above 12000/ml or purulent pulmonary secretions) with isolation of bacteria in a lower respiratory tract sample without modification of chest-X-Ray.'}, {'measure': 'ICU length of stay', 'timeFrame': 'at Day-90'}, {'measure': 'ICU mortality', 'timeFrame': 'at Day-90'}, {'measure': 'Hospital mortality', 'timeFrame': 'at Day-90'}, {'measure': 'Antibiotic free days', 'timeFrame': 'at Day-90'}]}, 'conditionsModule': {'keywords': ['Critical care', 'Mechanical ventilation', 'Ventilator associated pneumonia', 'Oral care'], 'conditions': ['Critical Care', 'Mechanical Ventilation', 'Ventilator Associated Pneumonia Prevention', 'Toothbrushing', 'Oral Care']}, 'referencesModule': {'references': [{'pmid': '29189950', 'type': 'DERIVED', 'citation': 'Ory J, Mourgues C, Raybaud E, Chabanne R, Jourdy JC, Belard F, Guerin R, Cosserant B, Faure JS, Calvet L, Pereira B, Guelon D, Traore O, Gerbaud L. Cost assessment of a new oral care program in the intensive care unit to prevent ventilator-associated pneumonia. Clin Oral Investig. 2018 Jun;22(5):1945-1951. doi: 10.1007/s00784-017-2289-6. Epub 2017 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia', 'detailedDescription': 'Prospective, before and after study in 5 Intensive Care Units (ICUs) of a university hospital.\n\nThe before period (control phase, 6 months): standard oral care 3 times a day in every consecutive intubated patients in the participating ICUs The interphase period (1 month): formal training of all the nurses, physicians and residents on the use of toothbrushing during oral care The after period: (study phase, 6 months): standard oral care with tooth brushing 3 times a day in every consecutive intubated patients in the participating ICUs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'mechanically ventilated patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Intubated mechanically ventilated ICU patient\n* Platelets count \\>50G/L\n\nExclusion Criteria:\n\n* Edentulous patients'}, 'identificationModule': {'nctId': 'NCT02400294', 'briefTitle': 'Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'CHU-0227'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Toothbrushing', 'type': 'OTHER', 'description': 'Toothbrushing associated with standard oral care in mechanically ventilated patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Russel CHABANNE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}