Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 7:42 PM
Study NCT ID:
NCT05575050
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2022-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Teeth Brushing in Ventilated COVID-19 Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D064806', 'term': 'Dysbiosis'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Patients were divided into 2 groups depending on the oral care procedure:\n\n1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)\n2. Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid) The procedures were performed twice daily in each patient. The detailed information on these procedures is included in the Appendix 1. The allocation protocol was based on patients' location in the ward. Each room was assigned with one type procedure (standard- even number or extended - uneven number of room), that was permanent during the study period."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare-associated infection', 'timeFrame': 'one month', 'description': 'Healthcare-associated infection (HAI) incidence was measured.'}], 'secondaryOutcomes': [{'measure': 'Oral cavity assessment', 'timeFrame': 'one month', 'description': 'Using The Beck Oral Assessment Scale (BOAS)'}, {'measure': 'Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae.', 'timeFrame': 'one month', 'description': 'Frequency of identification of Enterococcus fecalis, Acinetobacter baumannii, Klebsiella pneumoniae in different samples from oral cavity taken from ventilated COVID-19 patients on Intensive Care Unit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral microbiota', 'healthcare-associated infection'], 'conditions': ['Microbial Colonization', 'COVID-19 Respiratory Infection', 'Dysbiosis', 'VAP - Ventilator Associated Pneumonia', 'HAI']}, 'descriptionModule': {'briefSummary': "The aims of this study were:\n\n1. Observation of dynamics in oral microbiota and its association with the incidence of HAIs and VAP in mechanically ventilated COVID-19 patients in an ICU setting\n2. Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting\n3. Assessment of impact of different oral hygienic procedures on oral microbiota, the incidence of HAI and patients' safety in mechanically ventilated COVID-19 patients in an ICU setting approaches to oral care in an ICU setting\n\nIntervention of oral hygienic procedures implemented in study:\n\nPatients were divided into 2 groups depending on the oral care procedure:\n\n1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)\n2. Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SARS-CoV-2 infection confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasal and pharyngeal swabs upon hospital admission\n* Signed consent to participate in the study\n* Patients admitted to ICU\n* Intubation due to COVID-19 related pneumonia and acute respiratory distress syndrome (ARDS) within 24 hours preceding study procedures\n\nExclusion Criteria:\n\n* No consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT05575050', 'briefTitle': 'Impact of Teeth Brushing in Ventilated COVID-19 Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital in Krakow'}, 'officialTitle': 'Impact of Teeth Brushing on Bacterial Microbiota and Healthcare-associated Infections in Ventilated COVID-19 Patients', 'orgStudyIdInfo': {'id': '1072.6120.333.2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard oral procedure', 'description': 'Standard mouth cleaning protocol (without brushing) included:\n\n1. Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity.\n2. Using Sage Suction Swab (Toothette®), soaking in Perox-A-Mint Solution and cleaning with circular movements of each mucosal site for 10 seconds:\n\n 1. Right cheek mucosa and right upper quadrant\n 2. Left cheek mucosa and left upper quadrant\n 3. Left lower buccal quadrant\n 4. Right lower buccal quadrant\n3. Moisturizing with Mouth Moisturizer /firma/ of oral cavity mucosa, tongue and lips.\n4. Repeated suction of excess fluid from the oral cavity.', 'interventionNames': ['Procedure: Oral Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extended oral procedure', 'description': 'Extended mouth cleaning protocol (with brushing) included:\n\n1. Preparation of sterile catheter (12F lub 14F), suction of excess fluid from the oral cavity.\n2. Teeth brushing (each teeth quadrant for 30) using Sage Untreated Suction Toothbrush (SUST) connected to suction unit, moistured with sterile water.\n3. Using Sage Untreated Suction Toothbrush (SUST) moisturised with sterile water and cleaning with circular movements of each mucosal site for 10 seconds:\n\n 1. Right cheek mucosa and right upper quadrant\n 2. Left cheek mucosa and left upper quadrant\n 3. Left lower buccal quadrant\n 4. Right lower buccal quadrant\n4. Moisturizing with Mouth Moisturizer of oral cavity mucosa, tongue and lips.\n5. Repeated suction of excess fluid from the oral cavity.', 'interventionNames': ['Procedure: Oral Procedure']}], 'interventions': [{'name': 'Oral Procedure', 'type': 'PROCEDURE', 'description': 'Interventions included 2 variants of oral hygienic procedures. One was extended of teeth brushing.', 'armGroupLabels': ['Extended oral procedure', 'Standard oral procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'country': 'Poland', 'facility': 'Univeristy Hospital Kraków', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital in Krakow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mateusz Fiema', 'investigatorAffiliation': 'University Hospital in Krakow'}}}}