Anatomic Features of the Neck and Preoperative Tests as Predictive Markers of Difficult Laryngoscopy

November 3, 2016 updated by: Chara Liaskou, National and Kapodistrian University of Athens

Anatomic Features of the Neck and Preoperative Tests as Predictive Markers of Difficult Direct Laryngoscopy

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.

Study Overview

Status

Completed

Detailed Description

Difficult airway assessment is based on various anatomic parameters of upper airway, much of it being concentrated on oral cavity and the pharyngeal structures. The diagnostic value of tests based on neck anatomy in predicting difficult laryngoscopy was assessed in this study .

The sample consisted of adult patients scheduled to receive general anaesthesia. Anatomic features of the neck were measured pre-operatively.

The anatomic features of the neck measured were 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. The commonly used predictive tests head extension, mouth opening, upper lip bite test and Mallampati class were also measured.

The laryngoscopic view was classified according to the Cormack-Lehane Grade (1-4). Difficult laryngoscopy was defined as Cormack-Lehane Grade 3 or 4. Years of experience of the anaesthesiologists were recorded, as well as the number of tries needed to intubate the patient.

The optimal cut-off points for each predictive tests were identified by using receiver operating characteristic analysis. Sensitivity, specificity and positive predictive value and negative predictive value (NPV) were calculated for each test. Multivariate analysis with logistic regression, including all variables, was used to create a predictive model. Comparisons between genders were also performed to explore possible differences in diagnostic value and cut-off points. Finally, the years of experience of the clinician and the number of tries needed to intubate the patient were compared to assess risk of bias.

Study Type

Observational

Enrollment (Actual)

1142

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficult laryngoscopy classification using Cormack-Lehane Grade
Time Frame: immediate
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyromental distance measured in cm with a measuring tape
Time Frame: immediate
The distance from the mentum to the thyroid notch while the patient's neck is fully extended and the mouth closed
immediate
Sternomental distance measured in cm with a measuring tape
Time Frame: immediate
The distance from the suprasternal notch to the mentum while the patient's neck is fully extended and the mouth closed
immediate
Ratio of height to thyromental distance
Time Frame: immediate
Calculated ratio of the height in cm to the aforementioned thyromental distance
immediate
Thyrosternal distance calculated in cm
Time Frame: immediate
Calculated from the subtraction: sternomental (cm) minus thyromental (cm)
immediate
Neck circumference measured in cm with a measuring tape
Time Frame: immediate
Measurement at the level of the cricoid cartilage while the patient's neck is in neutral position
immediate
Ratio of neck circumference to thyromental distance
Time Frame: immediate
Calculated ratio of the neck circumference to the aforementioned thyromental distance
immediate
Hyomental distance at full head extension (FHE) measured in cm with a measuring tape
Time Frame: immediate
The distance from the mentum to the hyoid bone while the patient's neck is fully extended and the mouth closed
immediate
Hyomental distance at neutral position (NP) measured in cm with a measuring tape
Time Frame: immediate
The distance from the mentum to the hyoid bone while the patient's neck is in neutral position and the mouth closed
immediate
Ratio of hyomental distance at FHE to hyomental distance at NP
Time Frame: immediate
Calculated ratio of the aforementioned variables
immediate
Mallampati class
Time Frame: immediate
Classified as class I - soft palate, fauces, uvula, and pillars seen, class II - soft palate, fauces, and uvula seen, class III - soft palate and base of uvula seen and class IV - soft palate not visible.
immediate
Mouth opening measured in cm with a measuring tape
Time Frame: immediate
The distance between the upper and lower incisors with the mouth fully open
immediate
Upper lip bite test
Time Frame: immediate
Classified as class I - lower incisors can bite the upper lip above the vermilion line, class II - lower incisors can bite the upper lip below the vermilion line and class III - lower incisors cannot bite the upper lip.
immediate
Head extension measured in degrees with goniometer
Time Frame: immediate
The patient was asked to hold head erect, facing directly to the front, then asked to extend the head maximally and the examiner estimated the angle traversed by the occlusal surface of upper teeth using a goniometer.
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Chryssoula Staikou, MD, PhD, Assistant Professor, National and Kapodistrian University of Athens, 1st Department of Anaesthesia, Aretaieio Hospital

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

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

March 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 29, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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 Management

Subscribe