Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 12:24 AM
Study NCT ID:
NCT07346768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Airway-related complications', 'timeFrame': 'during anesthesia induction', 'description': 'Number of intubation attempts and need for airway adjuncts (stylet/bougie) and complications including desaturation and dental or soft tissue injury'}], 'primaryOutcomes': [{'measure': 'Cormack-Lehane grade III-IV', 'timeFrame': 'During anesthesia induction', 'description': 'Occurrence of difficult airway during anesthesia induction, defined by difficult laryngoscopy'}], 'secondaryOutcomes': [{'measure': 'Ultrasound-derived anterior neck soft tissue measurements', 'timeFrame': 'During anesthesia induction', 'description': 'diagnostic accuracy for predicting difficult airway (ROC-AUC)'}, {'measure': 'Intubation Difficulty Scale (IDS) score', 'timeFrame': 'during tracheal intubation', 'description': 'Difficult intubation: IDS score \\> 5'}, {'measure': 'Han Scale', 'timeFrame': 'during ventilation', 'description': 'Difficult mask ventilation: Han grade ≥ II'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'difficult airway', 'anterior neck ultrasound', 'ultrasonography'], 'conditions': ['Ultrasonography', 'Airway Management', 'Intubation, Intratracheal', 'Obesity and Overweight']}, 'referencesModule': {'references': [{'pmid': '37546081', 'type': 'RESULT', 'citation': 'Udayakumar GS, Priya L, Narayanan V. Comparison of Ultrasound Parameters and Clinical Parameters in Airway Assessment for Prediction of Difficult Laryngoscopy and Intubation: An Observational Study. Cureus. 2023 Jul 5;15(7):e41392. doi: 10.7759/cureus.41392. eCollection 2023 Jul.'}, {'pmid': '36844111', 'type': 'RESULT', 'citation': 'Kaul R, Singh D, Prakash J, Priye S, Kumar S, Bharati. Ultrasound Guided Measurement of Anterior Neck Tissue for the Prediction of Difficult Airway: A Prospective Observational Study. Rom J Anaesth Intensive Care. 2022 Dec 29;28(2):105-110. doi: 10.2478/rjaic-2021-0018. eCollection 2021 Dec.'}, {'pmid': '38812631', 'type': 'RESULT', 'citation': 'Akin S, Yildirim M, Artas H, Bolat E. Predicting difficult airway in morbidly obese patients using ultrasound. Turk J Med Sci. 2023 Nov 21;54(1):262-274. doi: 10.55730/1300-0144.5787. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Obese patients are at increased risk of difficult airway management due to anatomical changes in the anterior neck soft tissues. Accurate preoperative prediction of difficult airway remains challenging using conventional clinical airway assessment tests alone.\n\nThis prospective observational study aims to evaluate the role of ultrasound assessment of anterior neck soft tissue thickness in predicting difficult airway risk in overweight and obese adult patients undergoing elective surgery under general anesthesia. Ultrasound-based anterior neck measurements will be compared with standard clinical airway assessment parameters to determine their diagnostic accuracy for difficult laryngoscopy and intubation.\n\nThe results of this study may contribute to improved preoperative airway risk stratification and safer airway management in obese patients.', 'detailedDescription': 'Difficult airway management remains a major concern in anesthetic practice and is associated with increased morbidity, particularly in obese patients. Excess anterior neck soft tissue and altered upper airway anatomy contribute to challenges in mask ventilation, laryngoscopy, and tracheal intubation. Conventional clinical airway assessment tests have limited predictive accuracy in this population, highlighting the need for additional objective assessment tools.\n\nThis prospective observational study is designed to evaluate the predictive value of ultrasound-based assessment of anterior neck soft tissue thickness for difficult airway risk in overweight and obese adult patients undergoing elective surgery under general anesthesia. The study will be conducted at a single tertiary care center after ethics committee approval, and written informed consent will be obtained from all participants.\n\nEligible patients aged 18-70 years with a body mass index (BMI) greater than 25 kg/m² and classified as ASA physical status I-III will be included. Emergency surgeries, pregnant patients, individuals with known difficult airway history, maxillofacial anomalies, neck masses, or a BMI greater than 60 kg/m² will be excluded.\n\nPreoperative airway assessment will include conventional clinical parameters such as modified Mallampati score, mouth opening, interincisor distance, thyromental distance, sternomental distance, neck circumference, neck mobility, upper lip bite test, and snoring history. In addition, anterior neck ultrasound measurements will be performed preoperatively in the supine position using a high-frequency linear probe by trained anesthesiologists following a standardized protocol. Ultrasound parameters will include tongue dimensions, hyomental distance, skin-to-hyoid distance, skin-to-epiglottis distance, skin-to-vocal cords distance, skin-to-thyroid isthmus distance, skin-to-suprasternal notch distance, and the pre-epiglottic space to epiglottis-vocal cords distance ratio (PE/E-VC). Anterior neck ultrasound measurements will performed preoperatively by trained anesthesiologists using a standardized protocol.\n\nA single prospective cohort of overweight/obese surgical patients will undergo preoperative ultrasound and clinical airway assessments, and outcomes during induction will be recorded. After induction of general anesthesia, laryngoscopic view will be assessed using the Cormack-Lehane classification. Difficult laryngoscopy will be defined as Cormack-Lehane grade III or IV. Intubation difficulty will be evaluated using the Intubation Difficulty Scale (IDS), and mask ventilation difficulty will be assessed using the Han scale. Intraoperative airway management data, including number of intubation attempts, need for adjuncts, alternative techniques, and airway-related complications, will be recorded.\n\nStatistical analysis will focus on determining the diagnostic accuracy of ultrasound and clinical airway parameters. Receiver operating characteristic (ROC) curve analysis will be used to calculate the area under the curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value for each parameter and selected combinations. The findings aim to clarify the role of anterior neck ultrasound as a complementary tool for preoperative airway risk stratification in obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Overweight and obese adult patients undergoing elective surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* ASA physical status I-III\n\n \\* BMI \\>25 kg/m²\n* Scheduled for elective surgery under general anesthesia\n\nExclusion Criteria:\n\n* Emergency surgery\n* Pregnancy\n* Maxillofacial anomalies or neck masses\n* Rapid sequence induction\n* Previous history of difficult intubation\n* BMI \\>60 kg/m²'}, 'identificationModule': {'nctId': 'NCT07346768', 'briefTitle': 'Evaluation of Anterior Neck Ultrasound in Predicting Difficult Airway in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gaziantep City Hospital'}, 'officialTitle': 'Ultrasound Assessment of Anterior Neck Soft Tissue Thickness to Predict Difficult Airway Risk in Obese Patients Undergoing for Surgery Under General Anesthesia: an Observational Study', 'orgStudyIdInfo': {'id': 'GaziantepCH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overweight and Obese Surgical Patients', 'description': 'Adult overweight and obese patients undergoing elective surgery under general anesthesia who will receive standard care airway management.', 'interventionNames': ['Other: None (Observational study)']}], 'interventions': [{'name': 'None (Observational study)', 'type': 'OTHER', 'description': 'one group, there is no intervention. All measurements and observations will be performed during routine clinical care only', 'armGroupLabels': ['Overweight and Obese Surgical Patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gamze Nur Teke, medical doctor', 'role': 'CONTACT', 'email': 'gamzenur.koca@gmail.com', 'phone': '+905546634389'}, {'name': 'Gamze Nur Teke', 'role': 'CONTACT', 'email': 'gamzenur.koca@gmail.com'}], 'overallOfficials': [{'name': 'Gamze Nur Teke, medical doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziantep City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional data protection policies and the absence of participant consent for data sharing beyond the scope of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziantep City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gamze Nur Teke', 'investigatorAffiliation': 'Gaziantep City Hospital'}}}}