NCT03752593

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

November 21, 2018

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of difficulty in airway management

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

    two years

Study Arms (2)

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

ET TubeOTHER

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-ObeseObese

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heterogeneous group representing the general population of Muharraq

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hamad University Hospital

Al Muharraq, 24343, Bahrain

Location

Related Publications (13)

  • 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: 23836064BACKGROUND
  • Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431.

    PMID: 22459727BACKGROUND
  • 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: 16052126BACKGROUND
  • 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: 19502026BACKGROUND
  • 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: 21354999BACKGROUND
  • 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: 25431308BACKGROUND
  • 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: 12873960BACKGROUND
  • 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: 26994235BACKGROUND
  • 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: 10958088BACKGROUND
  • 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: 11867407BACKGROUND
  • Bond A. Obesity and difficult intubation. Anaesth Intensive Care. 1993 Dec;21(6):828-30. doi: 10.1177/0310057X9302100614. No abstract available.

    PMID: 8122742BACKGROUND
  • 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: 1824555BACKGROUND
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

    PMID: 6507827BACKGROUND

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

November 8, 2016

Primary Completion

October 8, 2018

Study Completion

November 8, 2018

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations