Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 5:22 PM
Study NCT ID:
NCT04390893
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2020-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound scoring system', 'timeFrame': "during procedure (after laryngeal mask's placement)", 'description': 'Anesthesiologist who are familiar with ultrasound would scan three planes of neck'}, {'measure': 'Air leakage test grading system', 'timeFrame': "during procedure (after laryngeal mask's placement)", 'description': 'Anesthesiologist would auscultate the degree of leakage'}, {'measure': 'Fiberoptic scoring system', 'timeFrame': 'procedure (after ultrasound examination or leakage test)', 'description': 'Anesthesiologist would confirm the position of LMA by fiberscope'}], 'secondaryOutcomes': [{'measure': 'Complications related to LMA (laryngeal mask airway )', 'timeFrame': '24 hours after surgery', 'description': 'such as reflection of tussis, sore throat, hoarseness, bleeding and so on'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound', 'air leakage test', 'bronchofiberscope'], 'conditions': ['Laryngeal Mask']}, 'referencesModule': {'references': [{'pmid': '27687463', 'type': 'RESULT', 'citation': 'Song K, Yi J, Liu W, Huang S, Huang Y. Confirmation of laryngeal mask airway placement by ultrasound examination: a pilot study. J Clin Anesth. 2016 Nov;34:638-46. doi: 10.1016/j.jclinane.2016.06.019. Epub 2016 Aug 3.'}, {'pmid': '29970248', 'type': 'RESULT', 'citation': 'Perez-Herrero MA, de la Varga O, Flores M, Sanchez-Ruano J, Otero M, Buisan F. Descriptive study of ultrasound images of the upper airway obtained after insertion of laryngeal mask. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):434-440. doi: 10.1016/j.redar.2018.05.004. Epub 2018 Jun 30. English, Spanish.'}, {'pmid': '27529028', 'type': 'RESULT', 'citation': 'Osman A, Sum KM. Role of upper airway ultrasound in airway management. J Intensive Care. 2016 Aug 15;4:52. doi: 10.1186/s40560-016-0174-z. eCollection 2016.'}, {'pmid': '25748523', 'type': 'RESULT', 'citation': 'Zhou ZF, Xia CZ, Wu M, Yu LN, Yan GZ, Ren QS, Hu CX, Yan M. Comparison of three methods for the confirmation of laryngeal mask airway placement in female patients undergoing gynecologic surgery. Ultrasound Med Biol. 2015 May;41(5):1212-20. doi: 10.1016/j.ultrasmedbio.2014.12.002. Epub 2015 Mar 5.'}, {'pmid': '25545750', 'type': 'RESULT', 'citation': 'Kim J, Kim JY, Kim WO, Kil HK. An ultrasound evaluation of laryngeal mask airway position in pediatric patients: an observational study. Anesth Analg. 2015 Feb;120(2):427-32. doi: 10.1213/ANE.0000000000000551.'}, {'pmid': '21689206', 'type': 'RESULT', 'citation': 'Ghai B, Ram J, Makkar JK, Wig J. Fiber-optic assessment of LMA position in children: a randomized crossover comparison of two techniques. Paediatr Anaesth. 2011 Nov;21(11):1142-7. doi: 10.1111/j.1460-9592.2011.03632.x. Epub 2011 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'Compare the accuracy of two methods of ultrasound and air leakage test in positioning laryngeal mask. Validate the relationship between ultrasound scores, air leak levels, and bronchoscopic classification in positioning laryngeal mask'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients selected for this study must meet all of the following criterion:\n\n 1. Age is between 17 to 65 years old;\n 2. ASA (Amecican Society of Anesthesiology ) scores I-II;\n 3. Actual weight is between 30 to 100 kilogram;\n 4. Patients undergo selective supine operations under general anesthesia (laryngeal mask);\n 5. Patients agree to participate in our study and sign Informed Consent Form\n\nExclusion Criteria:\n\n* Patients cannot participate in this study if they have any of the following conditions:\n\n 1. Airway stenosis, history of airway masses etc, whicn may cause obstruction to ventilation;\n 2. Swelling of the neck caused by huge mass in the neck and history of neck surgery etc, which doesn't contribute to ultrasound observation;\n 3. Stomach fullness, intestinal obstruction, gastroesophageal reflux disease etc, which may cause reflux aspiration."}, 'identificationModule': {'nctId': 'NCT04390893', 'briefTitle': 'Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test', 'organization': {'class': 'OTHER', 'fullName': "Shenzhen Second People's Hospital"}, 'officialTitle': 'Comparison of Ultrasound-guided Location of Laryngeal Mask With Air Leakage Test: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-12-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultrasound positioning group', 'interventionNames': ['Device: ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'leak test positioning group', 'interventionNames': ['Diagnostic Test: air leakage test']}], 'interventions': [{'name': 'ultrasound', 'type': 'DEVICE', 'description': 'Anesthesiologist would scan three planes of the neck to position the LMA', 'armGroupLabels': ['ultrasound positioning group']}, {'name': 'air leakage test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Anesthesiologist would use air leakage test to position the LMA', 'armGroupLabels': ['leak test positioning group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518035', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Xiong', 'role': 'CONTACT', 'email': 'levender14@163.com', 'phone': '+8613510602774'}], 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Li Xiong, master', 'role': 'CONTACT', 'email': 'levender14@163.com', 'phone': '+86-13510602774'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology Department', 'investigatorFullName': 'ZhiHeng Liu', 'investigatorAffiliation': "Shenzhen Second People's Hospital"}}}}