- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03752593
The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
October 21, 2019 updated by: Dr. Jaffar Albareeq, King Hamad University Hospital, Bahrain
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Muharraq, Bahrain, 24343
- King Hamad University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Heterogeneous group representing the general population of Muharraq
Description
Inclusion Criteria:
- Elective surgery
- BMI< 30 for Normal BMI group
- BMI > 30 for Obese group
Exclusion Criteria:
- Known previous difficult airway
- Pediatric patients.
- Emergency patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obese
Patients with a BMI of greater than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia
|
Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia
|
|
Non-Obese
Patients with a BMI of less than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia
|
Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of difficulty in airway management
Time Frame: two years
|
Assessment of Cormack Lehanne grading (intubation difficulty scale) IDS.
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
- Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Bond A. Obesity and difficult intubation. Anaesth Intensive Care. 1993 Dec;21(6):828-30. doi: 10.1177/0310057X9302100614. No abstract available.
- 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. Erratum In: Anesthesiology 1993 Jan;78(1):224.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2016
Primary Completion (Actual)
October 8, 2018
Study Completion (Actual)
November 8, 2018
Study Registration Dates
First Submitted
November 21, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (Actual)
November 26, 2018
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
October 21, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHUH/Anesthesia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Airway Obstruction
-
Ankara Etlik City HospitalRecruitingUpper Airway Obstruction | Airway StenosisTurkey (Türkiye)
-
University of UtahDynasthetics LLCNot yet recruitingObstruction Airway
-
University of CalgaryRecruitingForeign Body Airway ObstructionCanada
-
University of CalgaryRecruitingForeign Body Airway ObstructionCanada
-
Aerin MedicalNot yet recruitingNasal Airway Obstruction
-
Airiver Medical, Inc.Not yet recruitingPaclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis (OXYGEN-RCT)Tracheal Stenosis | Central Airway Stenosis | Central Airway Obstruction | Adult Subjects With Symptomatic Benign Airway Obstruction | Adult Benign Central Airway Stenosis | Adult Tracheobronchial StenosisUnited States
-
Beth Israel Deaconess Medical CenterMedWaves, IncTerminatedAirway Obstruction | Central Airway ObstructionUnited States
-
McMurray Medical Group, LLCCompletedUpper Airway ObstructionUnited States
-
Massachusetts General HospitalCompletedUpper Airway ObstructionUnited States
-
Rigshospitalet, DenmarkCompletedUpper Airway ObstructionDenmark
Clinical Trials on ET Tube
-
Hollister IncorporatedCompleted
-
University of Wisconsin, MadisonCompletedReplacement of Supralaryngeal AirwayUnited States
-
Entellus Medical, Inc.North American Science Associates Ltd.Completed
-
Stanford UniversityCompletedOutcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function TestingLung CancerUnited States
-
University of ZurichCompletedPatients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During SurgerySwitzerland
-
Menoufia UniversityAlexandria UniversityCompleted
-
Karolinska InstitutetRecruitingAnalgesia | RDS of Prematurity | Surfactant Deficiency Syndrome NeonatalSweden
-
Universidad de ZaragozaUniversity of ValladolidCompleted
-
Universidad Miguel Hernandez de ElcheNot yet recruitingSupraspinatus TendinopathySpain
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingChronic Conditions, MultipleUnited States