Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:06 AM
Study NCT ID:
NCT07461792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Method for Evaluation of Difficult Intubation in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary outcome evaluate using Ratio of Patient's Height to Thyromental Distance Combined with Obstruction and Neck Mobility (HON Model) as a new practical scoring system in predicting Difficult Laryngoscopy .", 'timeFrame': '30 min'}]}, 'conditionsModule': {'conditions': ['Difficult Airway Intubation']}, 'descriptionModule': {'briefSummary': 'There are multiple scores used for airway assesment ,the commonest one is LEMON score. LEMON is an airway assessment score that measures factors associated with difficult intubation such as obesity, head and neck movement, jaw movement , receding mandible, long upper incisors, Mallampatti scores, maxillary incisor characteristics, decreased mouth opening ,shorten thyromental distance and short neck.\n\nThe Height-to-Thyromental Distance ratio (H/TMD) has emerged as a simple, objective, and reproducible anatomical predictor of difficult laryngoscopy, as it normalizes mandibular space to patient height. However, airway difficulty is not purely anatomical; functional factors such as airway obstruction and cervical spine mobility significantly affect intubation success.\n\nTherefore, combining H/TMD with two highly predictive functional elements from the LEMON score - Obstruction (O) and Neck Mobility (N) - may provide a more accurate, simplified, and clinically applicable model for predicting difficult airway. This combination is referred to as the HON Model (Height/TMD + Obstruction + Neck mobility).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The sample size calculation was performed using G. power 3.1.9.2 (Universitat Kiel, Germany) and total sample size will be 350. It was calculated according to a previous study (Pal et al., 2025, Rista et al., 2025) based the sensitivity of Height/Thyromental Distance Ratio and L.E.M.O.N score as to best of our knowledge our study will be the first to assess Height/Thyromental Distance Ratio Combined with Obstruction and Neck Mobility (HON Model) to predict difficult intubation (Power : 0.8, α error: 0.05).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients from 15- 60 yrs old\n* Patients who require endotracheal intubation for surgery under general anesthesia.\n* Patients with ASA I - II\n* Patients who provide informed consent\n\nExclusion Criteria:\n\n* Patients with history of previous difficult intubation.\n* Patients with inability to sit/stand, heamodinamiclly unstable and need for rapid sequence induction .'}, 'identificationModule': {'nctId': 'NCT07461792', 'acronym': 'intubation', 'briefTitle': 'New Method for Evaluation of Difficult Intubation in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of Height/Thyromental Distance Ratio Combined With Obstruction and Neck Mobility for Predicting Difficult Endotracheal Intubation in Adults : A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Soh-Med-26-2-15MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '- Adult patients from 15- 60 yrs old - Patients who require endotracheal intubation for su', 'interventionNames': ['Other: evaluation of difficult intubation']}], 'interventions': [{'name': 'evaluation of difficult intubation', 'type': 'OTHER', 'description': 'The Height-to-Thyromental Distance ratio (H/TMD) has emerged as a simple, objective, and reproducible anatomical predictor of difficult laryngoscopy, as it normalizes mandibular space to patient height. However, airway difficulty is not purely anatomical; functional factors such as airway obstruction and cervical spine mobility significantly affect intubation success.\n\nTherefore, combining H/TMD with two highly predictive functional elements from the LEMON score - Obstruction (O) and Neck Mobility (N) - may provide a more accurate, simplified, and clinically applicable model for predicting difficult airway. This combination is referred to as the HON Model (Height/TMD + Obstruction + Neck mobility).', 'armGroupLabels': ['- Adult patients from 15- 60 yrs old - Patients who require endotracheal intubation for su']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'state': 'Nasser City', 'country': 'Egypt', 'facility': 'Faculty of Medicine Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia and ICU Resident at Sohag faculty of medicine', 'investigatorFullName': 'Mohamed Foaad', 'investigatorAffiliation': 'Sohag University'}}}}