Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT03641157
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Difficult Airway in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2018-03-31', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficult laryngoscopy classification using Cormack-LehaneGrade Assessment of difficult laryngoscopy at the time of the airway management procedure.', 'timeFrame': 'immediate', 'description': 'Classified as Grade I-visualization of entire laryngeal aperture, grade II-visualization of only posterior commissure of laryngeal aperture, grade III-visualization of only epiglottis, grade IV-visualization of just the soft palate.'}], 'secondaryOutcomes': [{'measure': 'Head circumference measured in cm with a measuring tape.', 'timeFrame': 'immediate', 'description': 'Head circumference were taken at the level above eyebrows and ears and measured in cm with a measuring tape.'}, {'measure': 'Weight measured in kilogram with electronic scale.', 'timeFrame': 'immediate', 'description': 'Weight measured using electronic scale (0-20 kg) while undressed and without diapers .'}, {'measure': 'Height measured in cm with infantometer.', 'timeFrame': 'immediate', 'description': 'Height measured using a portable infantometer (0-100 cm) while the child was in supine position.'}, {'measure': 'BMI was calculated as kg/m2.', 'timeFrame': 'immediate', 'description': 'BMI measured using a weight/height2 formul'}, {'measure': 'Percentage values measured in % with percentile tables.', 'timeFrame': 'immediate', 'description': 'Percentage (%) values using from the percentile tables of Turkish children were determined after the head circumference (cm), height (cm), weight (kg) and BMI (kg/m2) values of all pediatric cases were determined as described above.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Difficult intubation', 'Pediatrics', 'predictive tests'], 'conditions': ['Difficult Intubation', 'Pediatrics']}, 'referencesModule': {'references': [{'pmid': '22340664', 'type': 'RESULT', 'citation': 'Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.'}, {'pmid': '23083795', 'type': 'RESULT', 'citation': 'Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Cesnjevar R, Schmidt J. Incidence and predictors of poor laryngoscopic view in children undergoing pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2013 Jun;27(3):516-21. doi: 10.1053/j.jvca.2012.08.019. Epub 2012 Oct 17.'}, {'pmid': '25437694', 'type': 'RESULT', 'citation': 'Inal MT, Memis D, Sahin SH, Gunday I. [Comparison of different tests to determine difficult intubation in pediatric patients]. Rev Bras Anestesiol. 2014 Nov-Dec;64(6):391-4. doi: 10.1016/j.bjan.2014.02.001. Epub 2014 Aug 28. Portuguese.'}, {'pmid': '26968055', 'type': 'RESULT', 'citation': 'Mansano AM, Modolo NS, Silva LM, Ganem EM, Braz LG, Knabe Ade C, Freitas FM. Bedside tests to predict laryngoscopic difficulty in pediatric patients. Int J Pediatr Otorhinolaryngol. 2016 Apr;83:63-8. doi: 10.1016/j.ijporl.2016.01.031. Epub 2016 Feb 3.'}, {'pmid': '21401798', 'type': 'RESULT', 'citation': 'Mirghassemi A, Soltani AE, Abtahi M. Evaluation of laryngoscopic views and related influencing factors in a pediatric population. Paediatr Anaesth. 2011 Jun;21(6):663-7. doi: 10.1111/j.1460-9592.2011.03555.x. Epub 2011 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'Background: Obtaining airway security holds the utmost importance in anesthesia. Specific predictive tests or findings for difficult airway are not defined for various pediatric age groups. Anthropometric measurements are defined parallel to percentile curves in different age groups.\n\nAim: The aim of this study is to find out the value of body mass index and anthropometric measurements in prediction of difficult laryngoscopy in children by comparing to direct laryngoscopic evaluation of Cormack-Lehane test.\n\nMethods: Following institutional ethics committee approval and informed consent of parents of 108 patients (ages 0-3years), undergoing elective surgery were included in this study. Weight, height, body mass index and head circumference of the patients were measured and percentiles were recorded, prior to induction.\n\nFollowing standard anesthesia induction with thiopental all patients received 0,6 mg.kg-1 rocuronium intravenously. After sufficient time for neuromuscular relaxation laryngoscopy performed and Cormack-Lehane scores recorded. All recorded parameters were compared with Cormack-Lehane scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '1 Month', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Demographic data, head circumference, weight, height measurements, body mass index and percentile values were recorded by a pediatric surgeon who was unaware about the studyin the preoperative period.', 'genderDescription': 'pediatric patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0-3 years old (1-36 mounts) pediatric patients\n* Patients 0-3 age years old with ASA I, undergoing elective surgery were included in this study\n\nExclusion Criteria:\n\n* Patients with known syndrome, facial anomaly, ASA score above 2 and laryngeal mask aiway were excluded from the study'}, 'identificationModule': {'nctId': 'NCT03641157', 'briefTitle': 'Predicting Difficult Airway in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tepecik Training and Research Hospital'}, 'officialTitle': 'Value of BMI and Anthropometric Measurements With CL Test in Predicting Difficult Laryngoscopy in Children', 'orgStudyIdInfo': {'id': 'GAYDIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I Easy Intubation', 'description': 'Pediatric patients ages 0-3 years Easy Intubation (Cormach-Lehane score I-II)', 'interventionNames': ['Other: Easy Intubation']}, {'label': 'Group II Difficult intubation', 'description': 'Pediatric patients ages 0-3 years Difficult intubation (Cormach-Lehane score III-IV)', 'interventionNames': ['Other: Easy Intubation']}], 'interventions': [{'name': 'Easy Intubation', 'type': 'OTHER', 'otherNames': ['Difficult intubation'], 'armGroupLabels': ['Group I Easy Intubation', 'Group II Difficult intubation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Tepecik Education and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'PERVIN BOZKURT, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tepecik Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Value of BMI and Anthropometric Measurements with CL Test in Predicting Difficult Laryngoscopy in Children'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tepecik Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology and Reanimation Clinic, principal investigator, Clinical Associated Professor', 'investigatorFullName': 'GAYE AYDIN', 'investigatorAffiliation': 'Tepecik Training and Research Hospital'}}}}