NCT02957084

Brief Summary

In this prospective, open cohort study the diagnostic value of tests based on neck anatomy in predicting difficult laryngoscopy was assessed. The anatomic features of the neck measured were head extension, mouth opening, upper lip bite, Mallampati class, thyromental distance, sternomental distance, ratio of height to thyromental, neck circumference, thyrosternal distance, hyomental distance at full head extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental distance and ratio of hyomental distance FHE to hyomental distance NP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,142

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

October 29, 2016

Last Update Submit

November 3, 2016

Conditions

Keywords

difficult laryngoscopyneck circumferencesternomental distancethyromental distancehyomental distancethyrosternal distance

Outcome Measures

Primary Outcomes (1)

  • Difficult laryngoscopy classification using Cormack-Lehane Grade

    Assessment of difficult laryngoscopy at the time of the airway management procedure. 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.

    immediate

Secondary Outcomes (13)

  • Thyromental distance measured in cm with a measuring tape

    immediate

  • Sternomental distance measured in cm with a measuring tape

    immediate

  • Ratio of height to thyromental distance

    immediate

  • Thyrosternal distance calculated in cm

    immediate

  • Neck circumference measured in cm with a measuring tape

    immediate

  • +8 more secondary outcomes

Eligibility Criteria

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

Adult patients with BMI less than 35 kg/m2, wihthout any known neck or airway pathology, scheduled for surgical procedures under general anaesthesia with tracheal intubation were assessed for eligibility to be included in the study.

You may qualify if:

  • Adult patients
  • BMI less than 35 kg/m2
  • No known neck or airway pathology
  • Scheduled for surgical procedures under general anaesthesia with tracheal intubation

You may not qualify if:

  • Age less than 18 years
  • BMI higher than 35 kg/m2
  • Obvious airway malformations
  • Need for rapid sequence induction/intubation under cricoid pressure
  • Awake intubation
  • Cervical spine pathology requiring specific manipulation
  • Obstetric cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Epub 2008 Oct 23.

    PMID: 18946426BACKGROUND
  • Cheney FW. The American Society of Anesthesiologists Closed Claims Project: what have we learned, how has it affected practice, and how will it affect practice in the future? Anesthesiology. 1999 Aug;91(2):552-6. doi: 10.1097/00000542-199908000-00030. No abstract available.

    PMID: 10443619BACKGROUND
  • Chipas A, Ellis W, Zaglaniczny K. Airway management. In: Zaglaniczny K, Nagelhout J. Nurse Anesthesia. 3rd edition. USA: Elsevier Saunders; 2004:408

    BACKGROUND
  • Crosby ET, Cooper RM, Douglas MJ, Doyle DJ, Hung OR, Labrecque P, Muir H, Murphy MF, Preston RP, Rose DK, Roy L. The unanticipated difficult airway with recommendations for management. Can J Anaesth. 1998 Aug;45(8):757-76. doi: 10.1007/BF03012147.

    PMID: 9793666BACKGROUND
  • Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431.

    PMID: 22459727BACKGROUND
  • Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. doi: 10.1097/00000542-200507000-00009.

    PMID: 15983454BACKGROUND
  • Rucker JC, Cole D, Guerina LR, Zoran N, Chung F, Friedman Z. A prospective observational evaluation of an anatomically guided, logically formulated airway measure to predict difficult laryngoscopy. Eur J Anaesthesiol. 2012 May;29(5):213-7. doi: 10.1097/EJA.0b013e3283502168.

    PMID: 22450528BACKGROUND
  • 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
  • Koay CK. Difficult tracheal intubation--analysis and management in 37 cases. Singapore Med J. 1998 Mar;39(3):112-4.

    PMID: 9632969BACKGROUND
  • Burkle CM, Walsh MT, Harrison BA, Curry TB, Rose SH. Airway management after failure to intubate by direct laryngoscopy: outcomes in a large teaching hospital. Can J Anaesth. 2005 Jun-Jul;52(6):634-40. doi: 10.1007/BF03015776.

    PMID: 15983152BACKGROUND
  • Cattano D, Panicucci E, Paolicchi A, Forfori F, Giunta F, Hagberg C. Risk factors assessment of the difficult airway: an italian survey of 1956 patients. Anesth Analg. 2004 Dec;99(6):1774-1779. doi: 10.1213/01.ANE.0000136772.38754.01.

    PMID: 15562070BACKGROUND
  • Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. doi: 10.1007/BF03009858.

    PMID: 8055603BACKGROUND
  • Turkan S, Ates Y, Cuhruk H, Tekdemir I. Should we reevaluate the variables for predicting the difficult airway in anesthesiology? Anesth Analg. 2002 May;94(5):1340-4, table of contents. doi: 10.1097/00000539-200205000-00055.

    PMID: 11973217BACKGROUND
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

    PMID: 6507827BACKGROUND
  • Khan ZH, Kashfi A, Ebrahimkhani E. A comparison of the upper lip bite test (a simple new technique) with modified Mallampati classification in predicting difficulty in endotracheal intubation: a prospective blinded study. Anesth Analg. 2003 Feb;96(2):595-9, table of contents. doi: 10.1097/00000539-200302000-00053.

    PMID: 12538218BACKGROUND
  • Patil VU, Stehling LC, Zauder HL. Predicting the difficulty of intubation utilizing an intubation gauge. Anesthesiol Rev. 1983;10:32-3.

    BACKGROUND
  • Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. doi: 10.1093/bja/73.2.149.

    PMID: 7917726BACKGROUND
  • Naguib M, Malabarey T, AlSatli RA, Al Damegh S, Samarkandi AH. Predictive models for difficult laryngoscopy and intubation. A clinical, radiologic and three-dimensional computer imaging study. Can J Anaesth. 1999 Aug;46(8):748-59. doi: 10.1007/BF03013910.

    PMID: 10451134BACKGROUND
  • Gupta S, Sharma R, Jain D. Airway assessment: predictors of difficult airway. Indian J Anaesth. 2005:49(4):257-62

    BACKGROUND
  • Schmitt HJ, Kirmse M, Radespiel-Troger M. Ratio of patient's height to thyromental distance improves prediction of difficult laryngoscopy. Anaesth Intensive Care. 2002 Dec;30(6):763-5. doi: 10.1177/0310057X0203000607.

    PMID: 12500514BACKGROUND
  • Huh J, Shin HY, Kim SH, Yoon TK, Kim DK. Diagnostic predictor of difficult laryngoscopy: the hyomental distance ratio. Anesth Analg. 2009 Feb;108(2):544-8. doi: 10.1213/ane.0b013e31818fc347.

    PMID: 19151285BACKGROUND
  • Greek Society for Airway management, Basic and Advanced Management of the Airway, 2nd edition, Athens, 2011

    BACKGROUND

Study Officials

  • Chryssoula Staikou, MD, PhD, Assistant Professor

    National and Kapodistrian University of Athens, 1st Department of Anaesthesia, Aretaieio Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, Msc, Phd(c)

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 7, 2016

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 7, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share