Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04458220
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2020-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-12', 'size': 97872, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-23T04:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosed as a difficult airway', 'timeFrame': 'Just after intubation', 'description': 'C-L≥Ⅲ grade'}], 'secondaryOutcomes': [{'measure': 'Difficult mask ventilation', 'timeFrame': '2 minutes after administration of Rocuronium', 'description': 'The difficult mask ventilation was defined as follows: (1) the inability of an unassisted anesthesiologist to maintain oxygen saturation, as measured by SpO2\\<92% with 100% oxygen and positive-pressure mask ventilation; (2) significant gas flow leakage around the face mask; (3) the need to increase the gas flow to more than 15 L/min and use the oxygen flush valve more than twice (4) absence of visible chest movement; (5) the necessity to switch to a two-handed mask ventilation technique; (6) the need for operator substitution or addition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Difficult Airway']}, 'descriptionModule': {'briefSummary': "The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine . According to inclusion and exclusion criteria ,the investigators are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia. All enrolled participants must sign a written informed consent.In the preset studio,The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.Then,Statistical experts use quantitative software to quantify the data.The investigators will put all the data and images into a confidential database in order to build a large database of difficult airways.\n\nAnesthesiologist will give every patient an endotracheal intubation as planned. After that the anesthesiologist will be asked to fill out the questionnaire immediately.This questionnaire allows obtaining a ground truth for the intubation difficulty.All data will be used for AI deep learning and intelligent analysis,Several of the most relevant landmarks will be selected to build an early warning model.The overall study did not involve any intervention in the process of anaesthesia and operation of the patients, only the three-dimensional facial images of the patients were obtained, without any trauma or injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine . According to inclusion and exclusion criteria ,We are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients to be intubated under general anesthesia.\n\nExclusion Criteria:\n\n* Patients with deaf-mutism or communication disorders.\n* Patients with language deficiency or non-native language.\n* Patients with mental or central nervous system disease.\n* Patients with stupefaction or disturbance of consciousness.\n* Patients with terrible injury.\n* Patients cannot follow instructions to perform standard actions.\n* Patients participated in other relevant clinical investigation in the past 3 months.'}, 'identificationModule': {'nctId': 'NCT04458220', 'briefTitle': 'Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University"}, 'officialTitle': 'Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence', 'orgStudyIdInfo': {'id': 'SH9H-2020-T233-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'difficult airway', 'description': 'C-L≥Ⅲ grade', 'interventionNames': ['Other: photo and voice obtained']}, {'label': 'none difficult airway', 'description': 'C-L\\<Ⅲgrade', 'interventionNames': ['Other: photo and voice obtained']}], 'interventions': [{'name': 'photo and voice obtained', 'type': 'OTHER', 'description': 'The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.', 'armGroupLabels': ['difficult airway', 'none difficult airway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ming xia, Dr', 'role': 'CONTACT', 'email': 'jianghongjiuyuan@163.com', 'phone': '86-15021306970'}], 'facility': "The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ren Zhou, Dr', 'role': 'CONTACT', 'email': 'zhouren77@126.com', 'phone': '86-15121007303'}, {'name': 'Ming Xia, Dr', 'role': 'CONTACT', 'email': 'jianghongjiuyuan@163.com', 'phone': '86-15021306970'}], 'overallOfficials': [{'name': 'Hong Jiang, Dr', 'role': 'STUDY_CHAIR', 'affiliation': "The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}