Prediction of Difficult AirwayNCT07309978
Assessment Of Difficult Airway Predictors: A Prospective Comparison Of Upper Airway Ultrasound And Conventional Anthropometric Measures
An observational study of Prediction of Difficult Airway and Difficult Airway Intubation, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate whether upper airway ultrasound measurements can improve the prediction of difficult airway compared with conventional anthropometric assessments. Adult patients undergoing elective procedures requiring airway management will be included. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prediction of Difficult Airway, Difficult Airway Intubation
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2025to 25 Dec 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (18-99 years) scheduled for elective surgery under general anesthesia at a tertiary care hospital. Participants represent typical surgical patients requiring preoperative airway assessment. No healthy volunteers will be enrolled. Only ASA I-III patients who can provide informed consent will be included.
Who may be able to join
- Adults aged 18-99 years
- Patients scheduled for elective surgery under general anesthesia
- ASA Physical Status I-III
- Able to provide informed consent
- Undergoing preoperative airway evaluation
Who cannot join
- - Emergency surgery cases
- Age <18 years
- ASA Physical Status IV-V
- Pregnant or breastfeeding patients
- Patients with limited cooperation or inability to provide consent
- Known anatomical airway anomalies or previous major neck surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sağlık Bilimleri Üniversitesi
Ankara
sami eksert, MD, Assoc. Prof., +90 532 562 0597, exert79@yahoo.com
About this study
This prospective observational study aims to evaluate whether upper airway ultrasound measurements can improve the prediction of difficult airway compared with conventional anthropometric assessments. Adult patients undergoing elective procedures requiring airway management will be included. Ultrasound parameters such as tongue thickness, anterior neck soft tissue thickness, and hyomental distance will be measured before airway intervention. Standard clinical predictors (Mallampati score, thyromental distance, neck circumference, etc.) will also be recorded. The primary objective is to determine the diagnostic accuracy of ultrasound-based measurements in predicting difficult laryngoscopy and intubation. The study seeks to provide evidence supporting the integration of upper airway ultrasound into routine pre-anesthetic airway evaluation.
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 |
|---|---|---|
| Single Cohort | This cohort includes all adult participants undergoing airway evaluation with upper airway ultrasound and standard anthropometric measurements. No interventions are applied; participants are observed prospectively to assess the predictive value of ultrasound parameters for difficult airway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of ultrasound airway measurements for predicting difficult mask ventilation
Evaluation of the sensitivity, specificity, and area under the ROC curve (AUC) of ultrasound-based airway measurements-tongue thickness, hyoid-to-skin distance, and epiglottis-to-skin distance-in predicting difficult mask ventilation. These ultrasound parameters will be compared with conventional anthropometric airway assessment tests to determine their predictive performance.
Measured: Preoperative assessment (within 1 hour before induction of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start25 Dec 2025
- Primary completion25 Jul 2026 (estimated)
- Study completion25 Dec 2027 (estimated)
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 Prediction of 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Eksert, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309978
- Sponsor's protocol ID
- AEŞH-EK-2-25-276
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rastogi A, Singh AK, Srivastava D, Kannaujia AK, Singh TK, Mishra P. Evaluation of ultrasound measured tongue thickness, tongue thickness-thyromental distance ratio, and skin-to-epiglottis distance in predicting unanticipated difficult laryngoscopy. J Anaesthesiol Clin Pharmacol. 2025 Jan-Mar;41(1):151-157. doi: 10.4103/joacp.joacp_423_23. Epub 2025 Jan 23.
PubMed 40026745Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051.
PubMed 28403413Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Airway physical examination tests for detection of difficult airway management in apparently normal adult patients. Cochrane Database Syst Rev. 2018 May 15;5(5):CD008874. doi: 10.1002/14651858.CD008874.pub2.
PubMed 29761867
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Difficult Airway Predictors: A Prospective Comparison Of Upper Airway Ultrasound And Conventional Anthropometric Measures
- ClinicalTrials.gov ID
- NCT07309978
- Acronym / sponsor ID
- AEŞH-EK-2-25-276
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 30 Dec 2025 (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 whether upper airway ultrasound measurements can improve the prediction of difficult airway compared with conventional anthropometric assessments. Adult patients undergoing elective procedures requiring airway management will be included. Ultrasound parameters such as tongue thickness, anterior neck soft tissue thickness, and hyomental distance will be measured before airway intervention. Standard clinical predictors (Mallampati score, thyromental distance, neck circumference, etc.) will also be recorded. The primary objective is to determine the diagnostic accuracy of ultrasound-based measurements in predicting difficult laryngoscopy and intubation. The study seeks to provide evidence supporting the integration of upper airway ultrasound into routine pre-anesthetic airway evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort | – | –This cohort includes all adult participants undergoing airway evaluation with upper airway ultrasound and standard anthropometric measurements. No interventions are applied; participants are observed prospectively to assess the predictive value of ultrasound parameters for difficult airway. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (18-99 years) scheduled for elective surgery under general anesthesia at a tertiary care hospital. Participants represent typical surgical patients requiring preoperative airway assessment. No healthy volunteers will be enrolled. Only ASA I-III patients who can provide informed consent will be included.
Key inclusion criteria (5 listed)
- Adults aged 18-99 years
- Patients scheduled for elective surgery under general anesthesia
- ASA Physical Status I-III
- Able to provide informed consent
- Undergoing preoperative airway evaluation
Key exclusion criteria (6 listed)
- - Emergency surgery cases
- Age <18 years
- ASA Physical Status IV-V
- Pregnant or breastfeeding patients
- Patients with limited cooperation or inability to provide consent
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
Diagnostic accuracy of ultrasound airway measurements for predicting difficult mask ventilation
Time frame: Preoperative assessment (within 1 hour before induction of anesthesia)
Evaluation of the sensitivity, specificity, and area under the ROC curve (AUC) of ultrasound-based airway measurements-tongue thickness, hyoid-to-skin distance, and epiglottis-to-skin distance-in predicting difficult mask ventilation. These ultrasound parameters will be compared with conventional anthropometric airway assessment tests to determine their predictive performance.
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 10 Mar 2026.
- Background: PubMed 40026745Rastogi A, Singh AK, Srivastava D, Kannaujia AK, Singh TK, Mishra P. Evaluation of ultrasound measured tongue thickness, tongue thickness-thyromental distance ratio, and skin-to-epiglottis distance in predicting unanticipated difficult laryngoscopy. J Anaesthesiol Clin Pharmacol. 2025 Jan-Mar;41(1):151-157. doi: 10.4103/joacp.joacp_423_23. Epub 2025 Jan 23.
- Background: PubMed 28403413Yao W, Wang B. Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? Br J Anaesth. 2017 Apr 1;118(4):601-609. doi: 10.1093/bja/aex051.
- Background: PubMed 29761867Roth D, Pace NL, Lee A, Hovhannisyan K, Warenits AM, Arrich J, Herkner H. Airway physical examination tests for detection of difficult airway management in apparently normal adult patients. Cochrane Database Syst Rev. 2018 May 15;5(5):CD008874. doi: 10.1002/14651858.CD008874.pub2.
- Individual participant dataSharing planned: No
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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 Prediction of Difficult Airway and Difficult Airway Intubation, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of ultrasound airway measurements for predicting difficult mask ventilation (time frame: Preoperative assessment (within 1 hour before induction of anesthesia)). 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 NCT07309978, 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 10 Mar 2026.