Thyromental Height Test Versus Sternomental Displacement in Elderly

September 13, 2022 updated by: Bassant M. Abdelhamid, Cairo University

Thyromental Height Test Versus Sternomental Displacement Test for Prediction of Difficult Airway in Elderly Surgical Patients.

The study is designed to evaluate the validity of the SMDD as a predictor of difficult airway in elderly and to compare its validity with that of the TMHT.

Study Overview

Detailed Description

The airway assessment for difficulty before anesthesia in the elderly is crucial as the delay in the endotracheal intubation in this age group can lead to fatal consequences due to limited organ reserve and comorbidities. Previous studies revealed that elderly patients are predisposed to an increased incidence of difficult airway due to the age-related anatomic changes of the head and neck. These changes include, but not limited to, teeth loss, narrow dental arch, reduced oral soft tissue flexibility, TMJ dysfunction, degenerative change of ligament and tendons of the intervertebral discs causing compression of the intervertebral discs, cervical lordosis and spondylosis, limited head and upper neck extension, and fixed cervical spine flexion deformity.

Sternomental displacement (SMDD) is a relatively new objective airway measure that represents the difference between Sternomental distance that is measured while the head is extended on the neck (SMD-extension) and the Sternomental distance that is measured while the head is in a neutral position (SMD-neutral). The SMDD is a surrogate indicator of neck mobility. Both TMHT and SMDD were proved to be a good objective predictor for difficult laryngoscopy (DL) in adult surgical patients.

The TMHT was proved to have good predictive ability for difficult airway in elderly patients, but to the best of our knowledge, the SMDD was not previously evaluated in elderly. This study was designed to evaluate the validity of the SMDD as a predictor of difficult airway in elderly and to compare its validity with that of the TMHT. Our primary endpoint is the AUROC curve (area under receiver operating characteristic curve), sensitivity, specificity of the SMDD as a predictor of difficult laryngoscopy in elderly surgical patients. The secondary endpoint is to compare the validity of SMDD for predicting difficult airway with that of the TMHT and (Modified Mallampati test) MMT.

Study Type

Observational

Enrollment (Actual)

150

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

      • Cairo, Egypt, 1772
        • Faculty of Medicine-Cairo University

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

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In our study, 150 elderly patients who are scheduled for elective surgeries under general anesthesia with endotracheal intubation accomplished using conventional laryngoscopy will be included.

Description

Inclusion Criteria:

  1. elderly patients aged ≥ 65 years both male & female .
  2. ASA physical status I, II, and III .
  3. patients scheduled for elective surgeries under general anesthesia .

Exclusion Criteria:

  1. Patients undergoing emergency procedure
  2. patients requiring elective awake fiberoptic.
  3. patients having neuromuscular disorders or craniofacial abnormalities
  4. patients with cervical spine surgeries, neck scars, obvious limited neck extension.
  5. morbid obesity (MBI ˃40 kg/m2)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly
Elderly patients who are scheduled for elective surgeries under general anesthesia with endotracheal intubation accomplished using conventional laryngoscopy will be included.
Thyromental Height Test (TMHT) : will be measured while a patient is lying supine with the head and neck are maintained in a neutral position using a pillow under the head. By using a digital depth gauge, the TMH is the vertical distance measured between the anterior border of the thyroid cartilage directly on the thyroid notch and the anterior border of the mentum.
Sternomental displacement (SMDD): While the patient is sitting with the head in a neutral position, SMD-neutral will be measured using a tape as the distance between upper borders of the manubrium sterni and the mentum. The SMD-extension will then be measured in the same way with the head extended on the neck. The difference between SMD-extension and SMD-neutral will then be calculated as SMDD.
patients will be pre-oxygenated with 100% oxygen for 3 minutes, anesthesia will be then induced intravenously using fentanyl 2 μg/kg, propofol 1 -1.5 mg/kg, and succinylcholine 1 mg/kg lean body weight. Mask ventilation will be maintained till complete muscle relaxation guided by a peripheral nerve stimulator. Using Macintosh laryngoscopy, an anesthetist who has at least three years experience and who will be blinded to the preoperative tests' results, determined the best laryngeal view by using Cormack-Lehane (CL) grading system from I-IV. External neck manipulation will be used when needed to obtain the best laryngoscopic view. Endotracheal intubation will then be accomplished. The number and duration of intubation attempts will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sensitivity, specificity of the sternomental displacement as a predictor of difficult laryngoscopy in elderly surgical patients.
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyromental Height Test (TMHT)
Time Frame: 10 minutes
Thyromental Height Test (TMHT): will be measured while a patient is lying supine with the head and neck are maintained in a neutral position using a pillow under the head. By using a digital depth gauge, the TMH is the vertical distance measured between the anterior border of the thyroid cartilage directly on the thyroid notch and the anterior border of the mentum.
10 minutes
Sternomental displacement (SMDD)
Time Frame: 10 minutes
Sternomental displacement (SMDD): While the patient is sitting with the head in a neutral position, SMD-neutral will be measured using a tape as the distance between upper borders of the manubrium sterni and the mentum. The SMD-extension will then be measured in the same way with the head extended on the neck. The difference between SMD-extension and SMD-
10 minutes
Modified Mallampati test (MMT)
Time Frame: 10 minutes
Modified Mallampati test (MMT): the patient will be seated in a neutral position, the mouth is maximally opened, tongue protruded, and no phonation. According to the apparent oropharyngeal structures, the proper classification will be recorded.
10 minutes
Cormack-Lehane (CL) grading system
Time Frame: 10 minutes
Cormack-Lehane (CL) grading system from I-IV. (Grade I: full view of the glottis; grade II: glottis partly exposed, anterior commissure not seen; grade III: only epiglottis seen; grade IV: epiglottis not seen). Grade I &II will be categorized as easy laryngoscopy and grade III and IV as difficult laryngoscopy.
10 minutes
The number and duration of intubation attempts
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Abeer Ahmed, MD, Cairo University

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.

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)

June 10, 2022

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

September 10, 2022

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 45MS-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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