Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-17 @ 5:31 PM
Study NCT ID:
NCT04252469
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091982', 'term': 'Dental Care Team'}], 'ancestors': [{'id': 'D010348', 'term': 'Patient Care Team'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial Colonization (Gram stain)', 'timeFrame': 'at baseline (30 minutes before surgery started)', 'description': 'Bacterial Colonization'}, {'measure': 'Bacterial Colonization (Gram stain)', 'timeFrame': 'at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube )', 'description': 'Bacterial Colonization'}, {'measure': 'Bacterial Colonization (Gram stain)', 'timeFrame': 'after removal of endotracheal tube at recovery room (15 minutes after surgery ended)', 'description': 'Bacterial Colonization'}], 'secondaryOutcomes': [{'measure': 'Breathing odor assessment using questionnaire', 'timeFrame': 'at baseline (30 minutes before surgery started)', 'description': 'Breathing odor assessment'}, {'measure': 'Breathing odor assessment using questionnaire', 'timeFrame': 'at insertion of endotracheal tube', 'description': 'Breathing odor assessment'}, {'measure': 'Breathing odor assessment using questionnaire', 'timeFrame': 'after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)', 'description': 'Breathing odor assessment'}, {'measure': 'Breathing odor assessment using halitosis detector', 'timeFrame': 'at baseline (30 minutes before surgery started)', 'description': 'Breathing odor assessment'}, {'measure': 'Breathing odor assessment using halitosis detector', 'timeFrame': 'after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)', 'description': 'Breathing odor assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral care', 'Anesthesia', 'surgery', 'Intratracheal Intubation'], 'conditions': ['Intratracheal Intubation', 'Surgery', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '29766214', 'type': 'BACKGROUND', 'citation': 'Ricard JD, Lisboa T. Caution for chlorhexidine gluconate use for oral care: insufficient data. Intensive Care Med. 2018 Jul;44(7):1162-1164. doi: 10.1007/s00134-018-5217-6. Epub 2018 May 15. No abstract available.'}, {'pmid': '29744564', 'type': 'RESULT', 'citation': 'Deschepper M, Waegeman W, Eeckloo K, Vogelaers D, Blot S. Effects of chlorhexidine gluconate oral care on hospital mortality: a hospital-wide, observational cohort study. Intensive Care Med. 2018 Jul;44(7):1017-1026. doi: 10.1007/s00134-018-5171-3. Epub 2018 May 9.'}, {'pmid': '30247201', 'type': 'RESULT', 'citation': 'La Combe B, Maherault AC, Messika J, Billard-Pomares T, Branger C, Landraud L, Dreyfuss D, Dib F, Massias L, Ricard JD. Oropharyngeal Bacterial Colonization after Chlorhexidine Mouthwash in Mechanically Ventilated Critically Ill Patients. Anesthesiology. 2018 Dec;129(6):1140-1148. doi: 10.1097/ALN.0000000000002451.'}]}, 'descriptionModule': {'briefSummary': 'This single-centre, single-blind, randomised controlled study with parallel-group design was conducted in Yun Ling, Taiwan between May 2019 and August 2019. Participants were randomly allocated to an intervention (mouth care using 0.12% CHX before intubation) or control (standard care) group on a 1:1 basis. This study was approved by the institutional review board of National Taiwan University Hospital, Taiwan (IRB No.201806086RINB). Each participant completed written informed consent after explanation of this study and advised that they could withdraw anytime.', 'detailedDescription': 'Participants were recruited at the operation room of a teaching hospital. Participants were included if they met the following criteria: 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia. Patients were excluded if they were diagnosed with upper or lower respiratory tract disease, including COPD, cold, had oral ulcer, scheduled to have a respiratory-related surgical procedure, had endotracheal tube intubated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia.\n\nExclusion Criteria:\n\n* Patients were excluded if they were diagnosed with upper or lower respiratory tract disease, including COPD, cold, had oral ulcer, scheduled to have a respiratory-related surgical procedure, had endotracheal tube intubated, \\>1 during anesthesia processes,'}, 'identificationModule': {'nctId': 'NCT04252469', 'briefTitle': 'Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes', 'orgStudyIdInfo': {'id': '201806086RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds.', 'interventionNames': ['Other: Oral care']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standardized care'}], 'interventions': [{'name': 'Oral care', 'type': 'OTHER', 'description': 'oral care using 20mL of 0.12% CHX and gargling with 30 seconds.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Wyee Lee, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}