Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06892405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Airway US in Predicting Difficult Pediatric Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prediction of a Difficult laryngoscopy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords).', 'timeFrame': 'Preoperative', 'description': 'To evaluate the accuracy of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Namely the DSH, DSE, DSG, DSH+DSE, and DSH-DSE in prediction of difficult laryngoscopy.'}], 'secondaryOutcomes': [{'measure': 'The Modified Mallampati Score (MMS).', 'timeFrame': 'At Intubation', 'description': 'The Modified Mallampati Score (MMS):\n\n* Class I: Soft palate, uvula, fauces, pillars visible.\n* Class II: Soft palate, major part of uvula, fauces visible.\n* Class III: Soft palate, base of uvula visible.\n* Class IV: Only hard palate visible.'}, {'measure': 'The thyromental distance (TMD)', 'timeFrame': 'preoperative', 'description': 'The thyromental distance (TMD) is the distance from the chin (mentum) to the top of the notch of the thyroid cartilage with the head fully extended measured by a ruler.'}, {'measure': 'The upper lip bite test (ULBT)', 'timeFrame': 'Preoperative', 'description': 'The upper lip bite test (ULBT) performed by an anesthesiologist associated with this research and a specialist with more than 10 years of experience and in charge of the operating room.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Airway Complication of Anesthesia']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that ultrasound measurements may improve the preoperative detection of difficult laryngoscopy (DL) in pediatrics. The primary objective of this study will be to evaluate the usefulness for the prediction of a DL of five ultrasound measurements obtained from the neck skin to three structures of the upper airway (hyoid, epiglottis and anterior commissure of the vocal cords). Secondary objectives will include establishing, if possible, a cut-off point in these measurements; to compare these measures against the classic pre-intubation clinical screening tests.', 'detailedDescription': 'Current advances in airway management training have reduced the risk associated with an unanticipated DL but have not been able to reduce its incidence in clinical practice. The addition of new video laryngoscopes in our clinical practice seems to offer a paradigm shift to face a DL with promising results. However, theses authors also indicated that expertise in video laryngoscopy requires prolonged training and practice. Otherwise, a growing number of publications have showed that some ultrasound measurements may improve our anticipation of a DL because of its high accuracy to offer detailed anatomical images of the airway, absence of ionizing radiations, accessibility and reproducibility. Among all the ultrasound parameters studied, distance from skin to epiglottis with a cut-off point of 2.10 cm, showed the best predictive ability with a sensitivity of 83.33%3 and a specificity of 73.33%, for predicting difficulty in airway management in routine clinical practice. The aim of this study is to investigate the efficacy of US-measured airway structures in predicting difficult laryngoscopy (defined as CL grade III and IV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 2-6 years, ASA I, II who will be scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender both males and females\n* ASA Class I and II\n* Age 2 years to 6\n* Children scheduled for elective surgery under general anesthesia requiring orotracheal intubation after classical laryngoscopy.\n\nExclusion Criteria:\n\n* Congenital upper airway malformation,\n* Head and neck swellings,\n* Scars,\n* Radiation to the neck,\n* Tracheotomy,'}, 'identificationModule': {'nctId': 'NCT06892405', 'acronym': 'AirwayUS', 'briefTitle': 'Airway US in Predicting Difficult Pediatric Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Using Ultrasound to Predict the Difficulty of Direct Laryngoscopy in Pediatrics.', 'orgStudyIdInfo': {'id': '04-2024-201007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SonoSite™ S Series ultrasound', 'type': 'DEVICE', 'otherNames': ['US'], 'description': 'US measurements will be performed in the pre-operating room a\n\n, patients are placed in supine position with the head in a sniffing position on a surgical pillow and using the 15 MHz linear array transducer of the SonoSite™ S Series ultrasound in transverse position. A scan is made from the skin surface of the floor of the mouth to the trachea exerting the minimum possible pressure to identify the structures correctly.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '715715', 'city': 'Asyut', 'state': 'Assiut Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Hala S Abdel-Ghaffar, MD', 'role': 'CONTACT', 'email': 'hallasaad@yahoo.com', 'phone': '+2 01003812011'}, {'name': 'Karim A Hamouda, MBBCH', 'role': 'CONTACT', 'phone': '01148066608'}], 'facility': 'Assiut university Pediatric hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Hala S Abdel-Ghaffar, MD', 'role': 'CONTACT', 'email': 'hallasaad@yahoo.com', 'phone': '01003812011', 'phoneExt': '+20'}, {'name': 'Karim A Hamoda, MBBCH', 'role': 'CONTACT', 'phone': '01148066608', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Hala S Abdel-Ghaffar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia, intensive care and pain management', 'investigatorFullName': 'Hala Saad Abdel-Ghaffar', 'investigatorAffiliation': 'Assiut University'}}}}