Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT04505202
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
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': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathogen colonization change', 'timeFrame': 'change from baseline pathogen colonization at Day 3', 'description': 'We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)'}, {'measure': 'Oral assessment guide score change', 'timeFrame': 'at the time of admission into the study (day 0), at study day 2 and at day 3', 'description': 'The score ranges from 8 to 24 and higher scores indicating worse oral health'}, {'measure': 'Clinical pulmonary infection score change', 'timeFrame': 'at the time of admission into the study (day 0), at study day 2 and at day 3', 'description': 'The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )'}, {'measure': 'rate of tracheobronchitis change', 'timeFrame': 'change from baseline the rate of tracheobronchitis at Day 3', 'description': 'Questionary (use the rate of tracheobronchitis categories)'}], 'secondaryOutcomes': [{'measure': 'cost effectiveness', 'timeFrame': 'Day 30', 'description': 'We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.'}, {'measure': 'Mortality', 'timeFrame': 'Day 7 and Day 28', 'description': 'rate of mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilator Associated Pneumonia', 'Tracheobronchitis']}, 'descriptionModule': {'briefSummary': 'Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.', 'detailedDescription': 'The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission in critical care with in 24 hours\n* Having an endotracheal tube\n\nExclusion Criteria:\n\n* History of chlorhexidine allergy\n* Duration of mechanichal ventilation less than 48 h\n* Confirmed diagnosis of pneumonitis before admission in the ICU\n* Transfer from another ICU\n* Receiving chemotherapy or radiotherapy\n* Patients with immunodeficiency\n* Patients with tracheostomies\n* Required specific oral hygiene procedures\n* Facio-maxillary or dental trauma/surgery\n* Being pregnant'}, 'identificationModule': {'nctId': 'NCT04505202', 'briefTitle': 'Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications', 'organization': {'class': 'OTHER', 'fullName': 'Karabuk University'}, 'officialTitle': 'Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation', 'orgStudyIdInfo': {'id': '2091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '0.12% chlorhexidine gluconate', 'interventionNames': ['Drug: 0.12% chlorhexidine gluconate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'sodium bicarbonate', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '0.12% chlorhexidine gluconate', 'type': 'DRUG', 'description': 'The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sodium bicarbonate'], 'description': 'The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78050', 'city': 'Karabük', 'state': 'Karabük Province', 'country': 'Turkey (Türkiye)', 'facility': 'Karabük University Training and Research Hospital', 'geoPoint': {'lat': 41.20488, 'lon': 32.62768}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karabuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Duygu Kes', 'investigatorAffiliation': 'Karabuk University'}}}}