Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-06 @ 10:55 PM
Study NCT ID:
NCT03045094
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance of trachea carina (TC) to endotracheal tube (ETT) tip', 'timeFrame': '10min (time that the measurement need)', 'description': 'Measure the distance between trachea carina to the tip of ETT in three different neck-head positions: fully flexion, neutral positon and fully extension.'}], 'secondaryOutcomes': [{'measure': 'Distance of tracheal length', 'timeFrame': '10min (time that the measurement need)', 'description': 'Tracheal length equals the distance between trachea carina (TC) to posterior vocal commissure. Measure Tracheal length in three different neck-head positions: fully flexion, neutral positon and fully extension.'}, {'measure': 'Serious complication of unexpected displacement of the endotracheal tube: accidental extubation', 'timeFrame': 'intraoperative', 'description': "When the operator put the child's neck into extension position, accidental extubation may occur, which can lead to hypoxia and asphyxia."}, {'measure': 'Serious complication of unexpected displacement of the endotracheal tube: endobronchial intubation.', 'timeFrame': 'intraoperative', 'description': "When the operator put the child's neck into flexion position, accidental endobronchial intubation may occur, which can lead to one-lung ventilation and pulmonary edema."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'intubation', 'neck movement'], 'conditions': ['Pediatric Anesthesia', 'Tracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '7137685', 'type': 'BACKGROUND', 'citation': 'Dronen S, Chadwick O, Nowak R. Endotracheal tip position in the arrested patient. Ann Emerg Med. 1982 Feb;11(2):116-7. doi: 10.1016/s0196-0644(82)80328-4. No abstract available.'}, {'pmid': '9014541', 'type': 'BACKGROUND', 'citation': 'McCoy EP, Russell WJ, Webb RK. Accidental bronchial intubation. An analysis of AIMS incident reports from 1988 to 1994 inclusive. Anaesthesia. 1997 Jan;52(1):24-31. doi: 10.1111/j.1365-2044.1997.007-az007.x.'}, {'pmid': '16176312', 'type': 'BACKGROUND', 'citation': 'Mariano ER, Ramamoorthy C, Chu LF, Chen M, Hammer GB. A comparison of three methods for estimating appropriate tracheal tube depth in children. Paediatr Anaesth. 2005 Oct;15(10):846-51. doi: 10.1111/j.1460-9592.2005.01577.x.'}, {'pmid': '17121553', 'type': 'BACKGROUND', 'citation': 'Lau N, Playfor SD, Rashid A, Dhanarass M. New formulae for predicting tracheal tube length. Paediatr Anaesth. 2006 Dec;16(12):1238-43. doi: 10.1111/j.1460-9592.2006.01982.x.'}, {'pmid': '24958069', 'type': 'BACKGROUND', 'citation': "Gamble JJ, McKay WP, Wang AF, Yip KA, O'Brien JM, Plewes CE. Three-finger tracheal palpation to guide endotracheal tube depth in children. Paediatr Anaesth. 2014 Oct;24(10):1050-5. doi: 10.1111/pan.12452. Epub 2014 Jun 23."}, {'pmid': '3377215', 'type': 'BACKGROUND', 'citation': 'Bloch EC, Ossey K, Ginsberg B. Tracheal intubation in children: a new method for assuring correct depth of tube placement. Anesth Analg. 1988 Jun;67(6):590-2. No abstract available.'}, {'pmid': '16464981', 'type': 'BACKGROUND', 'citation': 'Weiss M, Knirsch W, Kretschmar O, Dullenkopf A, Tomaske M, Balmer C, Stutz K, Gerber AC, Berger F. Tracheal tube-tip displacement in children during head-neck movement--a radiological assessment. Br J Anaesth. 2006 Apr;96(4):486-91. doi: 10.1093/bja/ael014. Epub 2006 Feb 7.'}, {'pmid': '16192505', 'type': 'BACKGROUND', 'citation': 'Jin-Hee K, Ro YJ, Seong-Won M, Chong-Soo K, Seong-Deok K, Lee JH, Jae-Hyon B. Elongation of the trachea during neck extension in children: implications of the safety of endotracheal tubes. Anesth Analg. 2005 Oct;101(4):974-977. doi: 10.1213/01.ane.0000169330.92707.1e.'}, {'pmid': '19639372', 'type': 'BACKGROUND', 'citation': 'Kim JT, Kim HJ, Ahn W, Kim HS, Bahk JH, Lee SC, Kim CS, Kim SD. Head rotation, flexion, and extension alter endotracheal tube position in adults and children. Can J Anaesth. 2009 Oct;56(10):751-6. doi: 10.1007/s12630-009-9158-y. Epub 2009 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of head and neck movement in children on endotracheal tube (ETT) tip displacement undergoing head-and-neck surgeries. The tube-tip displacement will be measured using flexible fiberoptic bronchoscope.', 'detailedDescription': "In clinical application, especially in head-and-neck surgeries, the operators often change the position of children's head-neck for easy operating. Flexing the head resulted in the ETT moving towards the carina, and extension resulted in the tube being displaced in the opposite direction. Head and neck movement change the length of trachea as well: extending the head resulted in the extension of trachea, while flexing resulted in the opposite. Serious complications following from head and neck movement, such as accidental extubation and endobronchial intubation, threat children's life.\n\nIn pediatric anesthesia, insertion depth (cm) of orotracheal intubation equals to age/2+12, according to classic intubation formulae. The ETT will be put in the depth calculated by the classic formulae under general anesthesia. The distance of ETT-tip displacement and the length change of trachea will be measured as the head and neck placed as follows: fully extended, neutral position, or fully flexed. These three head and neck positions imitate the head-neck movement during those head-and-neck surgeries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children who schedul to undergo elective head-and-neck surgeries under general anesthesia with orotracheal intubation will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject has elective head-and-neck surgery schedule\n* subject will have orotracheal intubation under general anesthesia\n\nExclusion Criteria:\n\n* subject has malformations of the trachea or bronchus on chest X-ray\n* subject has spinal deformity\n* subject has difficulties in neck flexion or extension\n* subject has neck pain'}, 'identificationModule': {'nctId': 'NCT03045094', 'briefTitle': 'Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'Neck Flexion and Extension Implicate the Tracheal Tube-tip Displacement in Children Undergoing Head and Neck Surgeries', 'orgStudyIdInfo': {'id': '12015C1043'}}, 'contactsLocationsModule': {'locations': [{'zip': '102218', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'SIYI YAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Chang Gung Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Real time access', 'ipdSharing': 'YES', 'description': 'After recruiting, upload the distance of trachea carina(TC) to endotracheal tube (ETT) tip and the distance of tracheal length of each volunteer.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Doctor', 'investigatorFullName': 'Yan Siyi', 'investigatorAffiliation': 'Beijing Tsinghua Chang Gung Hospital'}}}}