Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT03752593
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000402', 'term': 'Airway Obstruction'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of difficulty in airway management', 'timeFrame': 'two years', 'description': 'Assessment of Cormack Lehanne grading (intubation difficulty scale) IDS.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Obstruction']}, 'referencesModule': {'references': [{'pmid': '23836064', 'type': 'BACKGROUND', 'citation': 'Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.'}, {'pmid': '22459727', 'type': 'BACKGROUND', 'citation': 'Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431.'}, {'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': '19502026', 'type': 'BACKGROUND', 'citation': 'Lavi R, Segal D, Ziser A. Predicting difficult airways using the intubation difficulty scale: a study comparing obese and non-obese patients. J Clin Anesth. 2009 Jun;21(4):264-7. doi: 10.1016/j.jclinane.2008.08.021. Epub 2009 Jun 6.'}, {'pmid': '21354999', 'type': 'BACKGROUND', 'citation': 'Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.'}, {'pmid': '25431308', 'type': 'BACKGROUND', 'citation': 'De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.'}, {'pmid': '12873960', 'type': 'BACKGROUND', 'citation': 'Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, Desmonts JM. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003 Aug;97(2):595-600. doi: 10.1213/01.ANE.0000072547.75928.B0.'}, {'pmid': '26994235', 'type': 'BACKGROUND', 'citation': 'Hashim MM, Ismail MA, Esmat AM, Adeel S. Difficult tracheal intubation in bariatric surgery patients, a myth or reality? Br J Anaesth. 2016 Apr;116(4):557-8. doi: 10.1093/bja/aew039. No abstract available.'}, {'pmid': '10958088', 'type': 'BACKGROUND', 'citation': 'Karkouti K, Rose DK, Wigglesworth D, Cohen MM. Predicting difficult intubation: a multivariable analysis. Can J Anaesth. 2000 Aug;47(8):730-9. doi: 10.1007/BF03019474.'}, {'pmid': '11867407', 'type': 'BACKGROUND', 'citation': 'Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.'}, {'pmid': '8122742', 'type': 'BACKGROUND', 'citation': 'Bond A. Obesity and difficult intubation. Anaesth Intensive Care. 1993 Dec;21(6):828-30. doi: 10.1177/0310057X9302100614. No abstract available.'}, {'pmid': '1824555', 'type': 'BACKGROUND', 'citation': 'Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021.'}, {'pmid': '6507827', 'type': 'BACKGROUND', 'citation': 'Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to identify the incidence of difficult endotracheal intubation in patients with normal BMI undergoing surgery under general anaesthesia in our hospital and compare it to that of obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heterogeneous group representing the general population of Muharraq', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* BMI\\< 30 for Normal BMI group\n* BMI \\> 30 for Obese group\n\nExclusion Criteria:\n\n* Known previous difficult airway\n* Pediatric patients.\n* Emergency patients'}, 'identificationModule': {'nctId': 'NCT03752593', 'briefTitle': 'The Incidence of Difficult Intubation in Obese Versus Non-obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Hamad University Hospital, Bahrain'}, 'officialTitle': 'The Incidence of Difficult Intubation in Obese Versus Non-obese Patients', 'orgStudyIdInfo': {'id': 'KHUH/Anesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese', 'description': 'Patients with a BMI of greater than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia', 'interventionNames': ['Other: ET Tube']}, {'label': 'Non-Obese', 'description': 'Patients with a BMI of less than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia', 'interventionNames': ['Other: ET Tube']}], 'interventions': [{'name': 'ET Tube', 'type': 'OTHER', 'description': 'Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia', 'armGroupLabels': ['Non-Obese', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24343', 'city': 'Al Muharraq', 'country': 'Bahrain', 'facility': 'King Hamad University Hospital', 'geoPoint': {'lat': 26.25722, 'lon': 50.61194}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Hamad University Hospital, Bahrain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'Dr. Jaffar Albareeq', 'investigatorAffiliation': 'King Hamad University Hospital, Bahrain'}}}}