Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-02 @ 11:12 PM
Study NCT ID:
NCT03938493
Status:
COMPLETED
Last Update Posted:
2021-06-01
First Post:
2019-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of cuff pressure during anesthesia', 'timeFrame': 'participants will followed until post-operative 1 day.', 'description': 'The investigators will monitor the pressure of the endotracheal tube cuff during anesthesia. The changes of the cuff pressure from the baseline value will be monitored continuously.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults who require endotracheal intubation for head and neck surgery under general anesthesia'], 'conditions': ['Intubation, Intratracheal']}, 'referencesModule': {'references': [{'pmid': '37342495', 'type': 'DERIVED', 'citation': 'Park S, Kwon YI, Kim HJ. Pressure changes in the endotracheal tube cuff in otorhinolaryngologic surgery: a prospective observational study. Front Med (Lausanne). 2023 Jun 5;10:1161566. doi: 10.3389/fmed.2023.1161566. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who require endotracheal intubation for head and neck surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Adults who require endotracheal intubation for head and neck surgery under general anesthesia\n\nExclusion Criteria:\n\n* 1\\. Patients under 20 years old\n* 2\\. Patients who should undergo tracheostomy\n* 3\\. Patients who need to use an endotracheal tube without a cuff\n* 4\\. Pregnant women\n* 5\\. Patients who can not read the consent form or are not fluent in Korean\n* 6\\. Patients who refused the clinical trial'}, 'identificationModule': {'nctId': 'NCT03938493', 'briefTitle': 'Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia', 'orgStudyIdInfo': {'id': '4-2019-0100'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endotracheal intubation under general anesthesia', 'description': 'Adults who require endotracheal intubation for head and neck surgery under general anesthesia', 'interventionNames': ['Other: monitoring of the endotracheal tube cuff']}], 'interventions': [{'name': 'monitoring of the endotracheal tube cuff', 'type': 'OTHER', 'description': 'We will enroll adult patients who will undergo endotracheal intubation for general anesthesia of head and neck surgery. The cuff pressure of the endotracheal tube will be monitored continuously during anesthesia. The cuff pressure value will be recorded and analyzed after completing the study.', 'armGroupLabels': ['endotracheal intubation under general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}