Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:29 AM
Study NCT ID:
NCT07343557
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Based Airway Assessment for Predicting Difficult Intubation in Adult Female Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Difficult Intubation', 'timeFrame': 'Perioperative', 'description': 'Difficult intubation defined as Cormack-Lehane grade III or IV and/or the need for additional airway devices or techniques during tracheal intubation.'}], 'secondaryOutcomes': [{'measure': 'Ultrasonographic Measurement of Tongue Thickness', 'timeFrame': 'Preoperative assessment', 'description': 'Preoperative ultrasonographic measurement of tongue thickness performed in the suprahyoid region.'}, {'measure': 'Ultrasonographic Measurement of Skin-to-Hyoid Bone Distance', 'timeFrame': 'Preoperative assessment', 'description': 'Preoperative ultrasonographic measurement of the distance between the skin and the hyoid bone.'}, {'measure': 'Ultrasonographic Measurement of Skin-to-Epiglottis Distance', 'timeFrame': 'Preoperative assessment', 'description': 'Preoperative ultrasonographic measurement of the distance between the skin and the epiglottis.'}, {'measure': 'Ultrasonographic Measurement of Distance from Skin to Anterior Commissure of the Vocal Cords', 'timeFrame': 'Preoperative assessment', 'description': 'Preoperative ultrasonographic measurement of the distance from the skin to the anterior commissure of the vocal cords.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway Ultrasound', 'Tongue Thickness', 'Difficult Airway'], 'conditions': ['Difficult Intubation', 'Airway Assessment']}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate the ability of selected ultrasonographic airway measurements to predict difficult intubation in adult female patients undergoing elective surgery. Pre-induction airway ultrasonography will be performed to measure tongue thickness and anterior neck soft tissue-related parameters. These measurements will be compared with laryngoscopic findings during direct laryngoscopy. The results of this study may help identify practical and reliable ultrasound-based markers for preoperative airway assessment and improve patient safety.', 'detailedDescription': 'This is a prospective, single-center observational study conducted in adult female patients scheduled for elective surgery under general anesthesia. The study was performed at the University of Health Sciences Adana City Training and Research Hospital after approval by the institutional ethics committee.\n\nBefore induction of anesthesia, standardized ultrasonographic airway assessments were performed by an experienced anesthesiologist. Measurements included tongue thickness, the distance from the skin to the anterior commissure of the vocal cords, the distance from the skin to the hyoid bone, and the distance from the skin to the epiglottis. All measurements were obtained under static pre-induction conditions using portable ultrasound equipment.\n\nFollowing anesthesia induction, direct laryngoscopy was performed, and laryngoscopic view was graded according to the Cormack-Lehane classification. Difficult intubation was defined based on predefined laryngoscopic criteria. Ultrasonographic measurements were then analyzed for their diagnostic performance in predicting difficult intubation.\n\nThe primary objective of the study was to determine the most informative ultrasonographic parameter for predicting difficult intubation in this population. Secondary objectives included comparing the relative diagnostic value of different ultrasound measurements and evaluating their potential role in routine preoperative airway assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female patients aged 18-65 years undergoing elective surgery under general anesthesia at a tertiary care hospital. Participants were non-pregnant and scheduled for non-emergency procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18-65 years\n* American Society of Anesthesiologists (ASA) physical status I-III physical status I-III\n* Scheduled for elective surgery under general anesthesia requiring tracheal intubation\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Body mass index ≥30 kg/m²\n* Known history of difficult intubation\n* Anatomical airway abnormalities or head and neck pathology\n* Pregnancy\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT07343557', 'acronym': 'USG-AIRWAY', 'briefTitle': 'Ultrasound-Based Airway Assessment for Predicting Difficult Intubation in Adult Female Patients', 'organization': {'class': 'OTHER', 'fullName': 'Adana City Training and Research Hospital'}, 'officialTitle': 'Diagnostic Performance of Ultrasonographic Airway Measurements for Predicting Difficult Intubation in Adult Female Patients: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'ADN-USG-AIRWAY-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Airway Ultrasound Assessment Cohort', 'description': 'Adult female patients undergoing elective surgery in whom preoperative airway ultrasonography was performed for observational assessment of airway anatomy. No intervention was assigned as part of the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '010650', 'city': 'Adana', 'state': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Adana City Training and Research Hospital', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adana City Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Uğur serkan Çitilcioğlu', 'investigatorAffiliation': 'Adana City Training and Research Hospital'}}}}