Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04711018
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Various Measures for Anticipating Difficult Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007828', 'term': 'Laryngoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2021-01-09', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficult laryngoscopy', 'timeFrame': 'Up to two weeks after preoperative examination', 'description': 'Grade III or IV laryngeal view before endotracheal intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cephalometry', 'Endotracheal intubation', 'Ethnicity', 'Laryngoscopy'], 'conditions': ['Difficult Laryngoscopy']}, 'referencesModule': {'references': [{'pmid': '16052126', 'type': 'BACKGROUND', '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.'}, {'pmid': '8638791', 'type': 'BACKGROUND', 'citation': 'el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.'}, {'pmid': '23364566', 'type': 'BACKGROUND', 'citation': 'Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.'}, {'pmid': '30630419', 'type': 'BACKGROUND', 'citation': 'Kim JC, Ki Y, Kim J, Ahn SW. Ethnic considerations in the upper lip bite test: the reliability and validity of the upper lip bite test in predicting difficult laryngoscopy in Koreans. BMC Anesthesiol. 2019 Jan 10;19(1):9. doi: 10.1186/s12871-018-0675-5.'}, {'pmid': '28443579', 'type': 'RESULT', 'citation': 'Yildirim I, Inal MT, Memis D, Turan FN. Determining the Efficiency of Different Preoperative Difficult Intubation Tests on Patients Undergoing Caesarean Section. Balkan Med J. 2017 Sep 29;34(5):436-443. doi: 10.4274/balkanmedj.2016.0877. Epub 2017 Apr 13.'}, {'pmid': '28183567', 'type': 'RESULT', 'citation': 'Selvi O, Kahraman T, Senturk O, Tulgar S, Serifsoy E, Ozer Z. Evaluation of the reliability of preoperative descriptive airway assessment tests in prediction of the Cormack-Lehane score: A prospective randomized clinical study. J Clin Anesth. 2017 Feb;36:21-26. doi: 10.1016/j.jclinane.2016.08.006. Epub 2016 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Demographic features and eight diagnostic variables were evaluated for difficult laryngoscopy (DL) predictivity. These were retrognathia, presence of buck teeth, modified Mallampati test (MMT), upper lip bite test (ULBT), sternomental distance (SMD), interincisor distance (IID), thyromental distance, and neck circumference. DL was identified by Grade III-IV view during laryngoscopy according to the Cormack-Lehane (CL) classification.', 'detailedDescription': 'Creating a regression model among selected bedside tests for predicting difficult laryngoscopy )defined as Grade III or IV view during laryngoscopy according to Cormack-Lehane classification) is the primary objective. Recruiting of 145 ASA I-II adult patients who would have an elective surgery under general anesthesia were planned.\n\nCriteria for exclusion were: a history of craniofacial surgery or restriction of cervical mobility, edentulous patients, pregnant women, patients who did not have a proper mouth opening (\\< 3 cm), and those who might require awake intubation or rapid sequence induction, cancellation of the surgery or change in the anesthetic strategy.\n\nThe selected tests and clinical situations were:\n\nThe presence of retrognathia (reduced temporomandibular joint-incisor distance) Buck teeth Modified Mallampati test (MMT) in the sitting position without phonation. A scale ranging between 1 and 4 points is used and scores of 3 or 4 are considered as predictors of DL. Upper lip bite test (ULBT) performed in a neutral position. ULBT is graded as 1-3 according to the extension ability of lower incisors.\n\nSternomental distance - The distance between the mentum and upper border of the manubrium sterni when the head is fully extended and the mouth is closed.\n\nThyromental distance (TMD) - The distance between mentum and the thyroid notch when the head is fully extended.\n\nInterincisor distance (IID) - The distance between upper and lower incisors when the mouth is fully opened.\n\nNeck circumference (NC) - It was measured at the level of the cricoid cartilage, perpendicular to the cervical axis.\n\nThe patients are premedicated with 0.03 mg/kg and oxygenated with the help of a bag-mask. Anesthesia is induced by consequent administration of 2 mcg/kg fentanyl, 1 mg/kg lidocaine, 2 mg/kg propofol, and 0.7 mg/kg rocuronium bromide thereafter. Two minutes after induction, the laryngoscopy is performed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients attending the anesthesiology out-patient clinic for preoperative evaluation in Kanuni Sultan Suleyman Ed. ad Research Hospital. The planned anesthetic method should be general anesthesia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Candidate for elective surgery under general anesthesia\n\nExclusion Criteria:\n\n* History of craniofacial surgery or restriction of cervical mobility,\n* Edentulous patients\n* Pregnancy\n* Patients who do not have a proper mouth opening (\\< 3 cm)\n* Patients who might require awake intubation or rapid sequence induction.'}, 'identificationModule': {'nctId': 'NCT04711018', 'acronym': 'COMPAD-T', 'briefTitle': 'Comparison of Various Measures for Anticipating Difficult Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Yedikule Training and Research Hospital'}, 'officialTitle': 'Comparison of Various Measures for Anticipating Difficult Laryngoscopy in Turkish Population: An Observational Study', 'orgStudyIdInfo': {'id': 'HasekiTRERH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group DL (+)', 'description': 'Grade III or IV laryngeal view according to Cormack-Lehane classification', 'interventionNames': ['Diagnostic Test: Laryngoscopy']}, {'label': 'Group DL (-)', 'description': 'Grade I or II laryngeal view according to Cormack-Lehane classification', 'interventionNames': ['Diagnostic Test: Laryngoscopy']}], 'interventions': [{'name': 'Laryngoscopy', 'type': 'DIAGNOSTIC_TEST', 'description': "The laryngoscopy is performed with the help of an appropriate size Macintosh blade. The patient's head is held in the sniffing position. External manipulation is not used for improving the view in this investigation.", 'armGroupLabels': ['Group DL (+)', 'Group DL (-)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34320', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Avcılar Murat Koluk State Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yedikule Training and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Avcılar Murat Koluk State Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Derya Ozden Omaygenc', 'investigatorAffiliation': 'Haseki Training and Research Hospital'}}}}