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CompletedNCT03752593Updated Oct 22, 2019

The Incidence of Difficult Intubation in Obese Versus Non-obese Patients

An observational study in Airway Obstruction, sponsored by King Hamad University Hospital, Bahrain. Completed at 1 site in Bahrain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by King Hamad University Hospital, Bahrain · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Airway Obstruction

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heterogeneous group representing the general population of Muharraq

Inclusion criteria

  • Elective surgery
  • BMI\< 30 for Normal BMI group
  • BMI > 30 for Obese group

Exclusion criteria

Exclusion Criteria:

  • Known previous difficult airway
  • Pediatric patients.
  • Emergency patients
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Obese

    Patients with a BMI of greater than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia

    Other: ET Tube

  • Non-Obese

    Patients with a BMI of less than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia

    Other: ET Tube

Interventions

  • OtherET Tube

    Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia

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What researchers measure

Primary outcomes

  1. Assessment of difficulty in airway management

    Assessment of Cormack Lehanne grading (intubation difficulty scale) IDS.

    Time frame: two years

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Study locations

1 site
  • King Hamad University Hospital
    Muharraq, 24343, Bahrain
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References and documents

Publications

  • 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. PubMed 23836064 ↗
  • Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431. PubMed 22459727 ↗
  • 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. PubMed 16052126 ↗
  • 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. PubMed 19502026 ↗
  • 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. PubMed 21354999 ↗
  • 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. PubMed 25431308 ↗
  • 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. PubMed 12873960 ↗
  • 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. PubMed 26994235 ↗
  • 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. PubMed 10958088 ↗
  • 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. PubMed 11867407 ↗
  • Bond A. Obesity and difficult intubation. Anaesth Intensive Care. 1993 Dec;21(6):828-30. doi: 10.1177/0310057X9302100614. No abstract available. PubMed 8122742 ↗
  • 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. PubMed 1824555 ↗
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11. PubMed 6507827 ↗
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Registry details

Key details

Study ID
NCT03752593
Lead sponsor
King Hamad University Hospital, Bahrain
Responsible party
Dr. Jaffar Albareeq (Director of Research, King Hamad University Hospital, Bahrain) — Principal investigator
First posted
Nov 26, 2018
Start date
Nov 8, 2016
Primary completion
Oct 8, 2018
Completion
Nov 8, 2018
Last update
Oct 22, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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