Difficult AirwayTMH-USGNCT07547943
TMH And Ultrasound For Difficult Airway Prediction
An observational study of Difficult Airway and Airway Management, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the predictive value of thyromental height (TMH) and ultrasonographic airway measurements in predicting difficult airway in adult patients undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway, Airway Management
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective surgical procedures under general anesthesia at a tertiary care hospital will be prospectively enrolled. All participants will undergo standardized preoperative airway assessment, including thyromental height measurement and ultrasonographic airway evaluation, followed by perioperative airway management assessment.
Who may be able to join
- Adult patients aged 18 years and older Patients scheduled for elective surgery under general anesthesia Patients requiring endotracheal intubation Patients who provide written informed consent
Who cannot join
- Patients with known upper airway pathology (e.g., tumor, trauma, infection) Patients with previous head and neck surgery or anatomical deformity affecting airway evaluation Patients with limited mouth opening (<3 cm) or severe cervical spine restriction Patients with contraindications to ultrasonographic examination Patients requiring rapid sequence induction or emergency surgery Patients who refuse to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation Of Thyromental Height And Ultrasonographic Airway Measurements In Predicting Difficult Airway: A Prospective Observational Study
This prospective observational study aims to evaluate the predictive value of thyromental height (TMH) and ultrasonographic airway measurements in predicting difficult airway in adult patients undergoing elective surgery under general anesthesia.
Preoperative airway assessment will include standard clinical evaluation, TMH measurement, and ultrasonographic measurements of anterior neck soft tissue. Perioperative airway management data, including intubation difficulty, number of attempts, and Cormack-Lehane classification, will be recorded.
The relationship between preoperative measurements and difficult airway will be analyzed to determine their predictive accuracy and clinical usefulness.
Read the detailed description
Difficult airway management remains a critical issue in anesthetic practice, associated with significant morbidity and mortality. Traditional clinical airway assessment methods have limited sensitivity and specificity in predicting difficult airway. Recently, thyromental height (TMH) and ultrasonographic airway measurements have been proposed as promising tools for improving prediction accuracy.
This prospective, single-center observational study will be conducted in adult patients undergoing elective surgery under general anesthesia. Patients aged 18 years and older with ASA physical status I-III will be included.
Preoperative evaluation will include standard airway assessment methods such as Mallampati score, mouth opening, sternomental distance, and thyromental distance. In addition, TMH will be measured, and ultrasonographic measurements of anterior neck soft tissues will be performed, including skin-to-epiglottis distance, pretracheal soft tissue thickness, and hyomental distance.
Perioperative airway management data will be recorded, including Cormack-Lehane classification, number of intubation attempts, use of adjunct airway devices, and intubation difficulty score.
The primary objective is to evaluate the predictive value of TMH and ultrasonographic measurements for difficult airway. Secondary objectives include assessing their relationship with intubation difficulty, number of attempts, and airway-related complications.
The findings of this study are expected to contribute to improved preoperative airway assessment and safer airway management strategies in clinical practice.
- Conditions
- Difficult Airway, Airway Management
- Keywords
- Thyromental Height, Airway Ultrasound, Difficult Intubation, Cormack-Lehane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Airway Assessment Cohort | Adult patients undergoing elective surgery under general anesthesia will be included. All participants will undergo standard preoperative airway assessment, including thyromental height (TMH) measurement and ultrasonographic airway evaluation. Intraoperative airway management and intubation-related parameters will be recorded to assess the predictive value of TMH and ultrasound measurements for difficult airway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Difficult Intubation
The primary outcome is the ability of thyromental height (TMH) and ultrasonographic airway measurements to predict difficult intubation. Difficult intubation will be defined as Cormack-Lehane grade ≥3, requirement of multiple intubation attempts, or use of advanced airway devices.
Measured: During induction of anesthesia (intraoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ulusoy, Emre, M.D.
- Responsible party
- Principal investigator, Serra Topal, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547943
- Sponsor's protocol ID
- TMH-USG-2026
- Acronym
- TMH-USG
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and protection of patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of Thyromental Height And Ultrasonographic Airway Measurements In Predicting Difficult Airway: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07547943
- Acronym / sponsor ID
- TMH-USG / TMH-USG-2026
- Conditions
- Difficult Airway, Airway Management
- Keywords
- Thyromental Height, Airway Ultrasound, Difficult Intubation, Cormack-Lehane
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Ulusoy, Emre, M.D.
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 23 Apr 2026 (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.
This prospective observational study aims to evaluate the predictive value of thyromental height (TMH) and ultrasonographic airway measurements in predicting difficult airway in adult patients undergoing elective surgery under general anesthesia.
Preoperative airway assessment will include standard clinical evaluation, TMH measurement, and ultrasonographic measurements of anterior neck soft tissue. Perioperative airway management data, including intubation difficulty, number of attempts, and Cormack-Lehane classification, will be recorded.
The relationship between preoperative measurements and difficult airway will be analyzed to determine their predictive accuracy and clinical usefulness.
Detailed description
Difficult airway management remains a critical issue in anesthetic practice, associated with significant morbidity and mortality. Traditional clinical airway assessment methods have limited sensitivity and specificity in predicting difficult airway. Recently, thyromental height (TMH) and ultrasonographic airway measurements have been proposed as promising tools for improving prediction accuracy.
This prospective, single-center observational study will be conducted in adult patients undergoing elective surgery under general anesthesia. Patients aged 18 years and older with ASA physical status I-III will be included.
Preoperative evaluation will include standard airway assessment methods such as Mallampati score, mouth opening, sternomental distance, and thyromental distance. In addition, TMH will be measured, and ultrasonographic measurements of anterior neck soft tissues will be performed, including skin-to-epiglottis distance, pretracheal soft tissue thickness, and hyomental distance.
Perioperative airway management data will be recorded, including Cormack-Lehane classification, number of intubation attempts, use of adjunct airway devices, and intubation difficulty score.
The primary objective is to evaluate the predictive value of TMH and ultrasonographic measurements for difficult airway. Secondary objectives include assessing their relationship with intubation difficulty, number of attempts, and airway-related complications.
The findings of this study are expected to contribute to improved preoperative airway assessment and safer airway management strategies in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway Assessment Cohort | – | –Adult patients undergoing elective surgery under general anesthesia will be included. All participants will undergo standard preoperative airway assessment, including thyromental height (TMH) measurement and ultrasonographic airway evaluation. Intraoperative airway management and intubation-related parameters will be recorded to assess the predictive value of TMH and ultrasound measurements for difficult airway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective surgical procedures under general anesthesia at a tertiary care hospital will be prospectively enrolled. All participants will undergo standardized preoperative airway assessment, including thyromental height measurement and ultrasonographic airway evaluation, followed by perioperative airway management assessment.
Key inclusion criteria (1 listed)
- Adult patients aged 18 years and older Patients scheduled for elective surgery under general anesthesia Patients requiring endotracheal intubation Patients who provide written informed consent
Key exclusion criteria (1 listed)
- Patients with known upper airway pathology (e.g., tumor, trauma, infection) Patients with previous head and neck surgery or anatomical deformity affecting airway evaluation Patients with limited mouth opening (<3 cm) or severe cervical spine restriction Patients with contraindications to ultrasonographic examination Patients requiring rapid sequence induction or emergency surgery Patients who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of Difficult Intubation
Time frame: During induction of anesthesia (intraoperative period)
The primary outcome is the ability of thyromental height (TMH) and ultrasonographic airway measurements to predict difficult intubation. Difficult intubation will be defined as Cormack-Lehane grade ≥3, requirement of multiple intubation attempts, or use of advanced airway devices.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and protection of patient confidentiality.
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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.
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 and Airway Management, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Apr 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serra Topal, MD (05068823855, dr.serra@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Difficult Intubation (time frame: During induction of anesthesia (intraoperative period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.