Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-31 @ 12:41 PM
Study NCT ID:
NCT04140357
Status:
UNKNOWN
Last Update Posted:
2019-10-25
First Post:
2019-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Ultrasonography in Airway Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy', 'timeFrame': '30 minutes before induction', 'description': 'The hyoid bone-skin distance will be measured by using ultrasound in centimeters'}, {'measure': 'Epiglottis-skin distance', 'timeFrame': '30 minutes before induction', 'description': 'The epiglottis-skin distance will be measured by using ultrasound in centimeters'}, {'measure': 'Thyroid isthmus-skin distance', 'timeFrame': '30 minutes before induction', 'description': 'The thyroid isthmus-skin distance will be measured by using ultrasound in centimeters'}, {'measure': 'Vocal cord-skin distance', 'timeFrame': '30 minutes before induction', 'description': 'The vocal cord-skin distance will be measured by using ultrasound in centimeters'}], 'secondaryOutcomes': [{'measure': 'Intubation difficulty scale score', 'timeFrame': '1 minutes after intubation', 'description': 'Each number of numbers attempt, operator and alternative techniques used, the Cormack Lehane score of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords count 1 point. A score of \\>5 indicates moderate-to-major difficulty'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obese Patients']}, 'referencesModule': {'references': [{'pmid': '26705531', 'type': 'BACKGROUND', 'citation': "Al-Qasmi A, Al-Alawi W, Malik AM, Manzoor Khan R, Kaul N. Comparison of Tracheal Intubation Using the Storz's C-Mac D-blade(TM) Video-Laryngoscope Aided by Truflex(TM) Articulating Stylet and the Portex(TM) Intubating Stylet. Anesth Pain Med. 2015 Dec 5;5(6):e32299. doi: 10.5812/aapm.32299. eCollection 2015 Dec."}, {'pmid': '25403231', 'type': 'RESULT', 'citation': 'Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.'}, {'pmid': '14616599', 'type': 'RESULT', 'citation': 'Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.'}, {'pmid': '16052126', 'type': 'RESULT', 'citation': 'Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. doi: 10.1097/00000542-200508000-00027.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasound is one of the most useful devices in daily anesthesia practice. Latest purpose of ultrasound usage is prediction of difficult intubation. In this study, we aimed to predict difficult laryngoscopy and intubation by using ultrasound measurement of neck soft tissue thickness in obese patient preoperatively.', 'detailedDescription': 'In this prospective and randomized controlled study, mallampati scores, interincisor gap, thyromental distance, neck circumference measurement and upper lip bite test scores will be recorded in sixty obese patients.\n\nAdditionally, neck tissue thickness will be recorded at 4 different levels (hyoid bone-skin distance, epiglot-skin distance , thyroid istmus-skin distance, vocal cord-skin distance) after the sniffing position by ultrasound with the linear probe. All measurements will be repeated three times and an average values will be recorded.\n\nAfter all this measurements, endotracheal intubation will be performed by an experienced anesthetist who is uninformed about study. During intubation the Cormack Lehane (C/L, grade 1: full view of the vocal cords; grade 2a: partial view of the glottis; 2b: posterior part of the vocal cord and arytenoids visible; grade 3: only epiglottis visible; and grade 4: neither epiglottis nor glottis visible) and the Intubation Difficulty Scale (IDS) score (the numbers of attempts, operators, and alternative techniques used, the C/L grade of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords. Every insertion of the laryngoscope and advancement of the tracheal tube towards the glottis counted as an attempt. A score of \\>5 indicates moderate-to-major difficulty) will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with obesity body mass index \\>30 undergoing surgery and requiring tracheal intubation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>30\n* 18-65 YEARS\n* ASA 1-2-3\n* Obese patients\n\nExclusion Criteria:\n\n* Pregnancy\n* Upper airway pathology\n* Cervical spine pathology\n* Laryngeal pathology'}, 'identificationModule': {'nctId': 'NCT04140357', 'briefTitle': 'Role of Ultrasonography in Airway Management', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'Is There a Role for Ultrasonography in the Airway Management of Patients With Obesity', 'orgStudyIdInfo': {'id': 'BasakUltrasonografi'}}, 'contactsLocationsModule': {'locations': [{'zip': '06080', 'city': 'Ankara', 'state': 'Province', 'country': 'Turkey (Türkiye)', 'facility': 'Başak Gülel', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Basak Gulel', 'role': 'CONTACT', 'email': 'dr.basakdemir@gmail.com', 'phone': '05061436261'}, {'name': 'Emine Arik', 'role': 'CONTACT', 'email': 'emineincearik@yahoo.com', 'phone': '05333471530'}], 'overallOfficials': [{'name': 'Basak Gulel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sbü Dışkapı Yıldırım Beyazıt Eğitim Ve Araştırma Hastanesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'başak gülel', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}