Difficult AirwayNCT05414214

Thyromental Height Test Versus Sternomental Displacement in Elderly

An observational study of Difficult Airway, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 65 to 90 years
Conditions the study is for: Difficult Airway
What is being tested?: Thyromental Height Test, Sternomental displacement and General anesthesia
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 150 participants
Where: 1 siteEgypt
Study dates: 10 Jun 2022to 10 Sep 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 90 years
All sexes
Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of medicine-Cairo University
Cairo, 1772

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Conditions: Difficult Airway
Being tested: Thyromental Height Test, Sternomental displacement, General anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thyromental Height TestProcedure or surgery
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 displacementProcedure or surgery
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.
General anesthesiaProcedure or surgery
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.

Study groups in NCT05414214
Study group	Role	What they receive
Elderly		Elderly patients who are scheduled for elective surgeries under general anesthesia with endotracheal intubation accomplished using conventional laryngoscopy will be included. Receives: Procedure: Thyromental Height Test; Procedure: Sternomental displacement; Procedure: General anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Thyromental Height Test (TMHT)
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.
Measured: 10 minutes
Sternomental displacement (SMDD)
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-
Measured: 10 minutes
Modified Mallampati test (MMT)
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.
Measured: 10 minutes
Cormack-Lehane (CL) grading system
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.
Measured: 10 minutes
The number and duration of intubation attempts
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202210 Sep 2022

First posted10 Jun 2022
Study start10 Jun 2022
Primary completion20 Aug 2022
Study completion10 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Difficult AirwayStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05414214
Sponsor's protocol ID: 45MS-2021
Status last verified: Sep 2022
First submitted: 8 Jun 2022
Last updated: 15 Sep 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26673904
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.
PubMed 24257384
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.
PubMed 28757825

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management

All Difficult Airway trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Thyromental Height Test Versus Sternomental Displacement Test for Prediction of Difficult Airway in Elderly Surgical Patients.
ClinicalTrials.gov ID: NCT05414214
Acronym / sponsor ID: 45MS-2021
Conditions: Difficult Airway
Study type: Observational
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 10 Jun 2022 (actual)
Primary completion: 20 Aug 2022 (actual)
Study completion: 10 Sep 2022 (actual)
First posted: 10 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Elderly	–	Procedure: Thyromental Height Test, Procedure: Sternomental displacement, Procedure: General anesthesiaElderly patients who are scheduled for elective surgeries under general anesthesia with endotracheal intubation accomplished using conventional laryngoscopy will be included.

Who may qualify

Ages: 65 to 90 years
Sex: All
Age groups: Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thyromental Height TestThyromental 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.	Procedure or surgery	Elderly
Sternomental displacementSternomental 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.	Procedure or surgery	Elderly
General anesthesiapatients 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.	Procedure or surgery	Elderly

Primary outcome

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

5 secondary outcomes

Thyromental Height Test (TMHT)
Time frame: 10 minutes
Sternomental displacement (SMDD)
Time frame: 10 minutes
Modified Mallampati test (MMT)
Time frame: 10 minutes
Cormack-Lehane (CL) grading system
Time frame: 10 minutes
The number and duration of intubation attempts
Time frame: 10 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
Background: PubMed 26673904Johnson 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.
Background: PubMed 24257384Etezadi 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.
Background: PubMed 28757825Prakash 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.
Individual participant dataSharing planned: No

Related trials for Difficult Airway

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abeer Ahmed, MD principal investigator

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Difficult Airway, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sensitivity, specificity of the sternomental displacement as a predictor of difficult laryngoscopy in elderly surgical patients. (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05414214, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.