Clinical trial NCT05414214: Thyromental Height Test Versus Sternomental Displacement in Elderly
Official title: Thyromental Height Test Versus Sternomental Displacement Test for Prediction of Difficult Airway in Elderly Surgical Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Airway
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: sensitivity, specificity of the sternomental displacement as a predictor of difficult laryngoscopy in elderly surgical patients.
timeFrame: 10 minutes
Secondary outcomes:
measure: Thyromental Height Test (TMHT)
timeFrame: 10 minutes
measure: Sternomental displacement (SMDD)
timeFrame: 10 minutes
measure: Modified Mallampati test (MMT)
timeFrame: 10 minutes
measure: Cormack-Lehane (CL) grading system
timeFrame: 10 minutes
measure: The number and duration of intubation attempts
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine-Cairo University
Study officials:
affiliation: Cairo University
name: Abeer Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson KN, Botros DB, Groban L, Bryan YF. Anatomic and physiopathologic changes affecting the airway of the elderly patient: implications for geriatric-focused airway management. Clin Interv Aging. 2015 Dec 4;10:1925-34. doi: 10.2147/CIA.S93796. eCollection 2015.
citation: Etezadi F, Ahangari A, Shokri H, Najafi A, Khajavi MR, Daghigh M, Moharari RS. Thyromental height: a new clinical test for prediction of difficult laryngoscopy. Anesth Analg. 2013 Dec;117(6):1347-51. doi: 10.1213/ANE.0b013e3182a8c734.
citation: Prakash S, Mullick P, Bhandari S, Kumar A, Gogia AR, Singh R. Sternomental distance and sternomental displacement as predictors of difficult laryngoscopy and intubation in adult patients. Saudi J Anaesth. 2017 Jul-Sep;11(3):273-278. doi: 10.4103/1658-354X.206798.