Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-02 @ 12:15 PM
Study NCT ID:
NCT03282604
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2017-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Georgia and the Islands']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-10', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intubation', 'Intratracheal', 'Nasopharynx'], 'conditions': ['Nasotracheal Intubation for General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '8346770', 'type': 'BACKGROUND', 'citation': 'Stoneham MD. The nasopharyngeal airway. Assessment of position by fibreoptic laryngoscopy. Anaesthesia. 1993 Jul;48(7):575-80. doi: 10.1111/j.1365-2044.1993.tb07119.x.'}, {'pmid': '9408424', 'type': 'BACKGROUND', 'citation': 'Reed DB, Clinton JE. Proper depth of placement of nasotracheal tubes in adults prior to radiographic confirmation. Acad Emerg Med. 1997 Dec;4(12):1111-4. doi: 10.1111/j.1553-2712.1997.tb03691.x.'}, {'pmid': '15845720', 'type': 'BACKGROUND', 'citation': 'Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.'}]}, 'descriptionModule': {'briefSummary': 'The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate the appropriateness of the tube depth and to suggest the ideal length of the nasotracheal tube during the intubation of the selected tracheal tube in consideration of the size of the nasal cavity in Koreans. 146 patients (73 males and 73 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the ideal length of tube that allows the distance from the vocal cords to the proximal portion of the tube cuff to be greater than 2 cm and the tip of the intubated tube to be located 5 ± 2 cm above the tracheal carina. The size of nostril, length from the nare to the carina and vocal cord are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are scheduled for nasotracheal intubation for general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients who are scheduled for nasotracheal intubation for general anesthesia\n\nExclusion Criteria:\n\n1. age\\<20 years\n2. ASA class III or more\n3. pregnancy\n4. emergency surgery\n5. nasal airway disease\n6. expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening \\<2cm, facial anomaly)\n7. cervical movement disorder (cervical disease, cervical pain)'}, 'identificationModule': {'nctId': 'NCT03282604', 'briefTitle': 'The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Ideal Length of the Nasotracheal Tube Considering Nasotracheal Tube Size', 'orgStudyIdInfo': {'id': '1-2017-0048'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'male'}, {'label': 'female'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Severance', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}