Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-05 @ 2:13 AM
Study NCT ID:
NCT06258603
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Care of Intubated Intensive Care Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012798', 'term': 'Sialorrhea'}, {'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064872', 'term': 'Patient Care Bundles'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single Blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The randomization of the study was achieved by the faculty member of the University's Faculty of Medicine, Department of Biostatistics and Medical Informatics, with the R version 3.1.3 program. First of all, the individuals included in the study were stratified according to two age groups (19-44 years and 45-70 years) in the computer environment. Then, individuals in each age group were included in the experimental and control groups in a balanced manner using the block randomization method. The randomization list was hidden from the researcher and the patient and was given to the researcher by a third party during the application. Eligibility and randomization assessment was performed by a critical care nurse independent of the study."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual Identification Form', 'timeFrame': 'First day of data collection', 'description': 'The form was prepared by the researcher in line with literature information. It consists of 9 questions covering the characteristics of the patients (demographic characteristics, diagnoses, APACHE II scores, Glasgow Coma Scale score, rules, feeding patterns, intubation tube number).'}, {'measure': 'Bedside Oral Exam Scale', 'timeFrame': 'Evaluated for five days.', 'description': 'Oral health was assessed using the scale. The scale consists of 8 subheadings (swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures, and smell). The scale score ranges from 8 points (perfect oral health) to 24 points (impaired oral health).'}, {'measure': "In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.", 'timeFrame': 'The 1st, 3rd and 5th days of oral care practices', 'description': 'Merck brand Universal pH 0-14 indicator was used to measure the saliva pH of the patients. The indicator was placed on the tongue and waited for 1 minute, and the resulting color change was compared with the color scale on the box. According to the literature, the average pH of unstimulated saliva has been determined to be approximately 6.8.'}, {'measure': "In this outcome measure, the patients' saliva amount was evaluated.", 'timeFrame': 'The 1st, 3rd and 5th days of oral care practices.', 'description': 'Schirmer Tear Test Strip was used in the application. The Modified Schirmer Test strip was placed under the tongue by holding its end with forceps, and after waiting for 3 minutes, the mm value of the wetness on the strip was read.'}, {'measure': 'In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.', 'timeFrame': 'Evaluated for five days.', 'description': 'To avoid bias regarding the method used, the diagnosis of ventilator associated pneumonia was made independently by the treatment team. In the Intensive Care Unit of Ege University Faculty of Medicine, Department of Anesthesiology and Reanimation, the diagnosis of ventilator associated pneumonia is made by the physician using the nosocomial infection diagnostic criteria of The Centers for Disease Control and Prevention (CDC). Information about the development of ventilator associated pneumonia was obtained from the infection control nurse.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral health', 'oral care', 'intensive care', 'nursing', 'intubation', 'dry mouth'], 'conditions': ['Pneumonia', 'Mechanical Ventilation Complication', 'Salivation', 'Dry Mouth']}, 'referencesModule': {'references': [{'pmid': '34855285', 'type': 'BACKGROUND', 'citation': "Abdelhafez AI, Tolba AA. Nurses' practices and obstacles to oral care quality in intensive care units in Upper Egypt. Nurs Crit Care. 2023 May;28(3):411-418. doi: 10.1111/nicc.12736. Epub 2021 Dec 2."}, {'pmid': '30499786', 'type': 'BACKGROUND', 'citation': "Alja'afreh MA, Mosleh SM, Habashneh SS. The Effects of Oral Care Protocol on the Incidence of Ventilation-Associated Pneumonia in Selected Intensive Care Units in Jordan. Dimens Crit Care Nurs. 2019 Jan/Feb;38(1):5-12. doi: 10.1097/DCC.0000000000000334."}, {'pmid': '10401348', 'type': 'BACKGROUND', 'citation': 'Andersson P, Persson L, Hallberg IR, Renvert S. Testing an oral assessment guide during chemotherapy treatment in a Swedish care setting: a pilot study. J Clin Nurs. 1999 Mar;8(2):150-8. doi: 10.1046/j.1365-2702.1999.00237.x.'}, {'pmid': '35037992', 'type': 'BACKGROUND', 'citation': 'Blot S, Deschepper M, Labeau S. De-adoption of chlorhexidine oral care and ICU mortality. Intensive Care Med. 2022 May;48(5):624-625. doi: 10.1007/s00134-022-06621-4. Epub 2022 Jan 17. No abstract available.'}, {'pmid': '31248697', 'type': 'BACKGROUND', 'citation': 'Chair SY, Chan DWK, Cao X. The interaction of subglottic drainage, cuff pressure, and oral care on endotracheal tube fluid leakage: A benchtop study. Aust Crit Care. 2020 Jul;33(4):358-363. doi: 10.1016/j.aucc.2019.05.002. Epub 2019 Jun 24.'}, {'pmid': '33037882', 'type': 'BACKGROUND', 'citation': 'Cuthbertson BH, Dale CM. Less daily oral hygiene is more in the ICU: yes. Intensive Care Med. 2021 Mar;47(3):328-330. doi: 10.1007/s00134-020-06261-6. Epub 2020 Oct 10. No abstract available.'}, {'pmid': '34609548', 'type': 'BACKGROUND', 'citation': 'Dale CM, Rose L, Carbone S, Pinto R, Smith OM, Burry L, Fan E, Amaral ACK, McCredie VA, Scales DC, Cuthbertson BH. Effect of oral chlorhexidine de-adoption and implementation of an oral care bundle on mortality for mechanically ventilated patients in the intensive care unit (CHORAL): a multi-center stepped wedge cluster-randomized controlled trial. Intensive Care Med. 2021 Nov;47(11):1295-1302. doi: 10.1007/s00134-021-06475-2. Epub 2021 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.', 'detailedDescription': 'Maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. Serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. Oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. In the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.In this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* mechanical ventilation support,\n* orally intubation\n* in the first 24 hours of intubation,\n* stable hemodynamic status\n\nExclusion Criteria:\n\n* pneumonia\n* Sjögren's Syndrome,\n* radiotherapy and/or chemotherapy,\n* oral care contraindications,\n* head and neck trauma,\n* platelet count below 50 thousand,\n* could not be positioned appropriately,\n* agitation"}, 'identificationModule': {'nctId': 'NCT06258603', 'briefTitle': 'Oral Care of Intubated Intensive Care Patient', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'The Effect of Oral Care Bundle Application on Salivary pH (Power of Hydrogen), Dry Mouth and Ventilator-associated Pneumonia in Intubated Patients', 'orgStudyIdInfo': {'id': '19-5T/40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients who received oral care bundle', 'description': '"A oral care bundle" protocol created by the researchers and it was applied by a researcher to experimental group.', 'interventionNames': ['Other: oral care bundle']}, {'type': 'OTHER', 'label': 'Patients receiving routine clinical oral care', 'description': "Routine oral care protocol used in intensive care unit was applied to control group by the patient's primary nurse.", 'interventionNames': ['Other: clinical oral care']}], 'interventions': [{'name': 'oral care bundle', 'type': 'OTHER', 'description': 'In the first stage, oral health was evaluated and data about the patient was collected.\n\nIn the second stage, an oral care bundle containing an oral care combination was applied to the experimental group. According to this bundle application, patients were received tooth brushing (with chlorhexidine solution) and ice water application twice a day and moisturizing attempts 4 times a day.\n\nIn the 3rd stage, saliva pH, dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.\n\nMeasurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.\n\nData regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.', 'armGroupLabels': ['Patients who received oral care bundle']}, {'name': 'clinical oral care', 'type': 'OTHER', 'description': "In the first stage, oral health was evaluated and data about the patient was collected.\n\nIn the second stage, routine oral care protocol used in intensive care unit was applied to patients by the patients' primary nurse. According to this application, patients were received oral care using tongue depressor with wrapped in gauze and chlorhexidine solution 4 times a day.\n\nIn the 3rd stage, saliva pH (power of hydrogen), dry mouth (amount of salivation) and ventilator associated pneumonia development status of the experimental group patients were evaluated.\n\nMeasurements were made by the researcher using the Bedside Oral Exam scale, pH (power of hydrogen) strip and Schirmer Tear Test Strip.\n\nData regarding whether patients were diagnosed with ventilator associated pneumonia were obtained from the Infection Control Committee.", 'armGroupLabels': ['Patients receiving routine clinical oral care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51100', 'city': 'Niğde', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Gül Güneş AKTAN', 'geoPoint': {'lat': 37.96583, 'lon': 34.67935}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It will be shared after the article is published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nigde Omer Halisdemir University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ege University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gül Güneş AKTAN', 'investigatorAffiliation': 'Nigde Omer Halisdemir University'}}}}