- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547943
TMH And Ultrasound For Difficult Airway Prediction (TMH-USG)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Serra Topal, MD
- Phone Number: 05068823855
- Email: dr.serra@msn.com
Study Locations
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Nilüfer
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Bursa, Nilüfer, Turkey (Türkiye), 16110
- Bursa City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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During induction of anesthesia (intraoperative period)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TMH-USG-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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