Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 11:54 PM
Study NCT ID:
NCT06626204
Status:
RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration and Application of Intelligent Difficult Airway Assessment Scheme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Modified Mallampati classification, Cormack-Lehane grading, thyromental distance, interincisal distance, and cervical mobility involved with the patient.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between intelligent airway assessment and modification of Mallampati classification and Cormack-Lehane grading.', 'timeFrame': 'From enrollment to one day after extubation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Difficult Airway', 'artificial intelligence', 'Modified Mallampati Classification'], 'conditions': ['Difficult Airway']}, 'descriptionModule': {'briefSummary': "The study aims to explore the effectiveness of an intelligent difficult airway assessment protocol and its potential in clinical applications. The management of difficult airways is a critical task in anesthesiology, and poor management can lead to severe complications or even death. The American Society of Anesthesiologists defines a difficult airway as one that presents difficulties in mask ventilation or endotracheal intubation. Previous studies have shown that the incidence of difficult airways is not low in patients undergoing general anesthesia, emphasizing the need for optimization of airway management strategies.\n\nPreoperative airway assessment is an essential step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are two commonly used assessment tools. However, these methods rely on the subjective judgment of clinicians and may have limitations in accuracy and consistency. With the development of artificial intelligence and telemedicine technologies, new assessment methods have become possible, offering more precise measurements and analysis of airway anatomy.\n\nThis study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways.\n\nAs a country with a large population, China has a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China's population may affect airway structure, thereby influencing airway management strategies. Therefore, conducting such research in China has important clinical significance and social value.", 'detailedDescription': "The research background is based on a critical issue in anesthetic practice - the management of difficult airways. A difficult airway refers to the challenges encountered during mask ventilation or endotracheal intubation, which can lead to severe complications or even death. The American Society of Anesthesiologists (ASA) defines a difficult airway as one that presents difficulties in mask ventilation, laryngoscopy, use of supraglottic airway devices, endotracheal intubation, extubation, or invasive airway access, including but not limited to situations that are anticipated or unanticipated. Studies have shown that the incidence of difficult and unventilatable mask airways in the general subject population is 2.2% and 0.15%, respectively, while the rate of difficult or failed intubation in general anesthesia events is between 0.43% and 0.52%. These data highlight the importance of accurate airway assessment before anesthesia.\n\nIn China, due to the large population, there is a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China's population, including regional, ethnic, and genetic background differences, may affect airway structure, thereby influencing airway management strategies. Therefore, conducting research on the assessment and management of difficult airways in China has important clinical and social significance.\n\nPreoperative airway assessment is a key step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are commonly used assessment tools in clinical practice. The modified Mallampati classification assesses the difficulty of the airway by observing the visibility of structures within the oral cavity, while the Cormack-Lehane grading assesses it through the visibility of laryngeal structures during direct laryngoscopy. Although these methods are widely used in clinical practice, they have issues with subjectivity, poor repeatability, and limited accuracy.\n\nWith the advancement of medical technology, especially the rapid development of artificial intelligence (AI) and telemedicine, new opportunities have emerged to improve the assessment methods for difficult airways. The use of intelligent devices and algorithms can provide more precise measurements and analysis of the subject's airway anatomy, thereby improving the accuracy and reliability of the assessment. This new method not only reduces the interference of subjectivity but also improves the repeatability of the assessment through standardized image collection and analysis processes.\n\nThis study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways.\n\nThe clinical significance of the study lies in the fact that, with more accurate airway assessment, anesthesiologists can take appropriate preventive measures and strategies in advance, reducing complications due to improper airway management, such as hypoxia, failed intubation, etc. This will directly improve surgical safety, reduce the postoperative recovery time and medical costs for subjects. In addition, the results of the study may also provide new theoretical bases and practical guidelines for the field of airway assessment, promoting the development and innovation of related technologies and methods.\n\nThe social value of conducting such research in China is that, with the trend of digital transformation in the medical industry, the application of intelligent airway assessment methods helps to improve overall medical efficiency and subject safety. In areas with limited resources or remote geographical locations, doctors can use remote connections and intelligent devices to assess the airways of subjects, achieving high-quality medical services."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective general anesthesia with endotracheal intubation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years, with no gender restrictions;\n* Subjects who are scheduled to undergo elective general anesthesia and require endotracheal intubation;\n* Subjects classified as American Society of Anesthesiologists Physical Status (ASA-PS) Class I, II, and III;\n* Volunteers who are willing to participate in this clinical trial and have signed the Informed Consent Form.\n\nExclusion Criteria:\n\n* Subjects with known airway deformities, tumors, or other structural abnormalities that may affect airway assessment;\n* Subjects with psychiatric disorders or other conditions that prevent cooperation;\n* Pregnant or lactating women;\n* Subjects who have participated in other interventional clinical trials within 1 month prior to the start of this trial;\n* Subjects deemed inappropriate to participate in this clinical trial by the investigator.'}, 'identificationModule': {'nctId': 'NCT06626204', 'briefTitle': 'Exploration and Application of Intelligent Difficult Airway Assessment Scheme', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Exploration and Application of Intelligent Difficult Airway Assessment Scheme', 'orgStudyIdInfo': {'id': '202409701'}}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjie Cheng', 'role': 'CONTACT', 'email': '2534493622@qq.com', 'phone': '17815370965'}], 'facility': 'First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Wenjie cheng', 'role': 'CONTACT', 'email': '2534493622@qq.com', 'phone': '17815370965'}], 'overallOfficials': [{'name': 'Min Su', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Min Su', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Min Su', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}