- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07343557
Ultrasound-Based Airway Assessment for Predicting Difficult Intubation in Adult Female Patients (USG-AIRWAY)
Diagnostic Performance of Ultrasonographic Airway Measurements for Predicting Difficult Intubation in Adult Female Patients: A Prospective Observational Study
Study Overview
Status
Conditions
Detailed Description
This is a prospective, single-center observational study conducted in adult female patients scheduled for elective surgery under general anesthesia. The study was performed at the University of Health Sciences Adana City Training and Research Hospital after approval by the institutional ethics committee.
Before induction of anesthesia, standardized ultrasonographic airway assessments were performed by an experienced anesthesiologist. Measurements included tongue thickness, the distance from the skin to the anterior commissure of the vocal cords, the distance from the skin to the hyoid bone, and the distance from the skin to the epiglottis. All measurements were obtained under static pre-induction conditions using portable ultrasound equipment.
Following anesthesia induction, direct laryngoscopy was performed, and laryngoscopic view was graded according to the Cormack-Lehane classification. Difficult intubation was defined based on predefined laryngoscopic criteria. Ultrasonographic measurements were then analyzed for their diagnostic performance in predicting difficult intubation.
The primary objective of the study was to determine the most informative ultrasonographic parameter for predicting difficult intubation in this population. Secondary objectives included comparing the relative diagnostic value of different ultrasound measurements and evaluating their potential role in routine preoperative airway assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Adana
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Adana, Adana, Turkey (Türkiye), 010650
- Adana City Training and Research 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:
- Female patients aged 18-65 years
- American Society of Anesthesiologists (ASA) physical status I-III physical status I-III
- Scheduled for elective surgery under general anesthesia requiring tracheal intubation
- Ability to provide informed consent
Exclusion Criteria:
- Body mass index ≥30 kg/m²
- Known history of difficult intubation
- Anatomical airway abnormalities or head and neck pathology
- Pregnancy
- Emergency surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Airway Ultrasound Assessment Cohort
Adult female patients undergoing elective surgery in whom preoperative airway ultrasonography was performed for observational assessment of airway anatomy.
No intervention was assigned as part of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Difficult Intubation
Time Frame: Perioperative
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Difficult intubation defined as Cormack-Lehane grade III or IV and/or the need for additional airway devices or techniques during tracheal intubation.
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Perioperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasonographic Measurement of Tongue Thickness
Time Frame: Preoperative assessment
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Preoperative ultrasonographic measurement of tongue thickness performed in the suprahyoid region.
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Preoperative assessment
|
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Ultrasonographic Measurement of Skin-to-Hyoid Bone Distance
Time Frame: Preoperative assessment
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Preoperative ultrasonographic measurement of the distance between the skin and the hyoid bone.
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Preoperative assessment
|
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Ultrasonographic Measurement of Skin-to-Epiglottis Distance
Time Frame: Preoperative assessment
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Preoperative ultrasonographic measurement of the distance between the skin and the epiglottis.
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Preoperative assessment
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Ultrasonographic Measurement of Distance from Skin to Anterior Commissure of the Vocal Cords
Time Frame: Preoperative assessment
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Preoperative ultrasonographic measurement of the distance from the skin to the anterior commissure of the vocal cords.
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Preoperative assessment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ADN-USG-AIRWAY-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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