Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06183060
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Decision Support System of Difficult Airway Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'inter-incisor gap', 'timeFrame': 'measurement one day before operation]', 'description': 'physical indicator'}, {'measure': 'thyromental distance', 'timeFrame': 'measurement one day before operation]', 'description': 'physical indicator'}, {'measure': 'neck circumference,', 'timeFrame': 'measurement one day before operation]', 'description': 'physical indicator'}, {'measure': 'modified Mallampati test,', 'timeFrame': 'measurement one day before operation]', 'description': 'physical indicator'}], 'primaryOutcomes': [{'measure': 'Cormack-Lehane (CL) classification', 'timeFrame': 'During induction', 'description': 'describe laryngeal view during direct laryngoscopy'}], 'secondaryOutcomes': [{'measure': 'X1(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'distance between the temporomandibular joint and tip of the upper incisors'}, {'measure': 'X2(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'perpendicular distance from the hard palate to the tip of the upper incisors'}, {'measure': 'X3(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'length of the mandibular body'}, {'measure': 'X4(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'vertical distance from the highest point of the hyoid bone to the mandibular body'}, {'measure': 'X5(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'distance from the antero-inferior border of the fourth cervical vertebra to the antero-superior border of the first cervical vertebra'}, {'measure': 'X6(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'atlanto-occipital gapantero-superior border of the first cervical vertebra'}, {'measure': 'X7(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'horizontal distance from the highest point of the hyoid bone to the border of the nearest cervical vertebra'}, {'measure': 'X8(X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'distance between the spinous processes of the first cervical vertebra and the second cervical vertebra'}, {'measure': 'A1 (X-ray indicators)', 'timeFrame': 'During review the X-ray image', 'description': 'the angle between a line passing through the bottom of second cervical vertebra and a line passing through the bottom of sixth cervical vertebra in the neutral/ extension position'}, {'measure': 'Hp-h (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'the distance from back end of the hard palate to the top of hyoid'}, {'measure': 'Ht (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'the height of the tongue base, along Hp-h from the tongue to the top of hyoid'}, {'measure': 'Dt-p (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'the distance from the back end of tongue to posterior pharyngeal wall'}, {'measure': 'Dt (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'the distance from the back end of tongue to Hp-h'}, {'measure': 'S (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'the central sectional area of the tongue base behind Hp-h'}, {'measure': 'W (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'the maximal width of the tongue base'}, {'measure': 'V (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'volume of the tongue base'}, {'measure': 'Rs (CT/MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'Rs= S/( Hp-h\\* Dt-p); Rv =V/( Hp-h\\* Dt-p\\*W)'}, {'measure': 'MRI1 (MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'distance between the base of the tongue and the posterior pharyngeal wall'}, {'measure': 'MRI2 (MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'distance between the epiglottis and the posterior pharyngeal wall'}, {'measure': 'MRI3 (MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'distance between the uvula and the posterior pharyngeal wall'}, {'measure': 'MRI4 (MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'distance between the vocal cords and the posterior pharyngeal wall'}, {'measure': 'MRI5 (MRI indicators)', 'timeFrame': 'During review the CT/MRI image', 'description': 'length of the epiglottis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Difficult Airway']}, 'referencesModule': {'references': [{'pmid': '28376741', 'type': 'RESULT', 'citation': 'Han YZ, Tian Y, Xu M, Ni C, Li M, Wang J, Guo XY. Neck circumference to inter-incisor gap ratio: a new predictor of difficult laryngoscopy in cervical spondylosis patients. BMC Anesthesiol. 2017 Apr 4;17(1):55. doi: 10.1186/s12871-017-0346-y.'}, {'pmid': '29388207', 'type': 'RESULT', 'citation': 'Han YZ, Tian Y, Zhang H, Zhao YQ, Xu M, Guo XY. Radiologic indicators for prediction of difficult laryngoscopy in patients with cervical spondylosis. Acta Anaesthesiol Scand. 2018 Apr;62(4):474-482. doi: 10.1111/aas.13078. Epub 2018 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'Based on the evaluation of preoperative physical indicators and radiologic indicators of cervical surgery, this study puts forward effective indicators for predicting difficult airway before operation, and establishes a comprehensive decision support system of difficult airway evaluation, so as to provide a theoretical basis for the early warning of difficult airway before cervical spondylosis surgery.', 'detailedDescription': 'In the past, the evaluation of difficult airway mainly depended on physical indicators, but the internal structure of airway could not be found by appearance inspection. Therefore, unexpected emergency airway often appeared in clinical work, which seriously affected medical safety. In this study, the specific mechanism of difficult laryngoscopy in patients undergoing cervical spondylosis surgery is clarified by the combination of the physical indicators and radiologic indicators. On this basis, we will establish the preoperative airway evaluation system for cervical spondylosis surgery, optimize the standardized process of preoperative airway evaluation, and accurately screen out high-risk patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing elective cervical spine surgery for cervical spondylosis (spinal cord and nerve root type', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of ASA I-III\n* scheduled for elective surgery for cervical spondylosis under general anesthesia with tracheal intubation\n\nExclusion Criteria:\n\n* patients with cervical spine instability\n* oropharyngeal mass\n* airway disease\n* preoperative imaging data were incomplete\n* refuse to sign informed consent'}, 'identificationModule': {'nctId': 'NCT06183060', 'briefTitle': 'Study on the Decision Support System of Difficult Airway Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Department of Anesthesiology, Peking University Third Hospital, Associate Chief Physician; M.D.', 'orgStudyIdInfo': {'id': 'IRB00006761-M2022105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'difficult laryngoscopy group', 'description': 'Cormack-Lehane (C-L) scale: class III-IV', 'interventionNames': ['Procedure: endotracheal intubation']}, {'label': 'easy laryngoscopy group', 'description': 'Cormack-Lehane (C-L) scale: class I-II', 'interventionNames': ['Procedure: endotracheal intubation']}], 'interventions': [{'name': 'endotracheal intubation', 'type': 'PROCEDURE', 'description': 'all patients will receive laryngoscopy and endotracheal intubation', 'armGroupLabels': ['difficult laryngoscopy group', 'easy laryngoscopy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongzheng Han, M.D.', 'role': 'CONTACT', 'email': 'hanyongzheng@bjmu.edu.cn', 'phone': '+86 15201304460'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yongzheng Han, M.D.', 'role': 'CONTACT', 'email': 'hanyongzheng@bjmu.edu.cn', 'phone': '+86 15201304460'}], 'overallOfficials': [{'name': 'Yongzheng Han, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'after the project finished and manuscript published', 'ipdSharing': 'YES', 'description': 'if necessary, access the data by contacting the project leader', 'accessCriteria': 'contact the project leader and data can only be used for scientific research'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}