- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694154
Ultrasonographic Airway Assessment and VIDIAC Score
Evaluation of the Relationship Between Ultrasonographic Airway Measurements, Videolaryngoscopic Intubation Findings, and the Video Intubation Difficulty Assessment Classification (VIDIAC) Score in Adult Patients: A Prospective Observational Study
Study Overview
Status
Detailed Description
Difficult airway management is a major cause of anesthesia-related morbidity and mortality. Airway ultrasonography has emerged as a noninvasive tool for evaluating airway anatomy and may help predict difficult intubation. The Video-Intubation Difficulty Assessment Classification (VIDIAC) score is a recently developed and standardized method for assessing videolaryngoscopic intubation difficulty.
This prospective, observational, single-center study aims to evaluate the relationship between preoperative ultrasonographic airway measurements and the VIDIAC score in adult patients undergoing elective surgery under general anesthesia. Ultrasonographic measurements, including tongue depth, tongue thickness, hyomental distance, hyoid depth, hyoid width, and distance from skin to epiglottis, will be obtained before anesthesia induction.
Videolaryngoscopic intubation will be performed by anesthesiologists blinded to the ultrasound findings, and the VIDIAC score will be recorded. The study will assess the correlation between ultrasonographic airway measurements and the VIDIAC score, as well as the ability of these measurements to predict difficult videolaryngoscopic intubation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Betül Çiftçi Kurt
- Phone Number: 5301785995
- Email: betulciftcikurt@gmail.com
Study Contact Backup
- Name: Hatice Selçuk Kuşderci
- Phone Number: 0 505 215 98 96
- Email: drkusderci@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 to 80 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for endotracheal intubation under general anesthesia.
- Patients who provide written informed consent.
Exclusion Criteria:
- Known airway abnormalities.
- Head and neck tumors.
- Patients with a tracheostomy.
- Pregnant patients.
- Emergency surgical procedures.
- Patients with limited cervical mobility.
- Patients with facial trauma.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the relationship between preoperative ultrasonographic airway measurements and the VIDIAC score.
Time Frame: During videolaryngoscopic intubation
|
The relationship between preoperative ultrasonographic airway measurements and the Videolaryngoscopic Intubation and Difficult Airway Classification (VIDIAC) score will be evaluated in adult patients undergoing videolaryngoscopic intubation.
The simplified VIDIAC score classifies patients as easy (-1 or 0), moderate (1), hard (2), or severe (≥3), with higher scores indicating greater videolaryngoscopic intubation difficulty.
Correlations between ultrasonographic airway measurements and the VIDIAC score will be analyzed.
|
During videolaryngoscopic intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation Time
Time Frame: During videolaryngoscopic intubation
|
The duration of videolaryngoscopic intubation, measured from insertion of the videolaryngoscope into the oral cavity until successful placement of the endotracheal tube.
|
During videolaryngoscopic intubation
|
|
First-Attempt Intubation Success Rate
Time Frame: During videolaryngoscopic intubation
|
The proportion of patients successfully intubated on the first videolaryngoscopic attempt without the need for additional intubation attempts.
|
During videolaryngoscopic intubation
|
|
Requirement for Additional Airway Maneuvers
Time Frame: During videolaryngoscopic intubation
|
The need for additional airway maneuvers during videolaryngoscopic intubation, including external laryngeal manipulation, repositioning, use of a bougie, stylet adjustment, or other adjunctive techniques to facilitate successful intubation.
|
During videolaryngoscopic intubation
|
|
Occurrence of Oxygen Desaturation
Time Frame: During videolaryngoscopic intubation
|
The occurrence of oxygen desaturation during videolaryngoscopic intubation, defined as a decrease in peripheral oxygen saturation (SpO₂) below 90%.
|
During videolaryngoscopic intubation
|
|
Number of Intubation Attempts
Time Frame: During videolaryngoscopic intubation
|
The total number of videolaryngoscopic intubation attempts required to achieve successful endotracheal intubation.
An intubation attempt is defined as insertion of the videolaryngoscope into the oral cavity with the intention of placing the endotracheal tube.
|
During videolaryngoscopic intubation
|
|
Incidence of Difficult Videolaryngoscopic Intubation
Time Frame: During videolaryngoscopic intubation
|
The incidence of difficult videolaryngoscopic intubation will be determined using the Videolaryngoscopic Intubation and Difficult Airway Classification (VIDIAC) score.
The simplified VIDIAC score is classified as follows: easy (-1 or 0), moderate (1), hard (2), and severe (≥3), with higher scores indicating greater videolaryngoscopic intubation difficulty.
Patients classified as having difficult videolaryngoscopic intubation according to the predefined VIDIAC criteria will be identified, and the incidence will be calculated.
|
During videolaryngoscopic intubation
|
|
Cormack-Lehane Grade
Time Frame: During videolaryngoscopic intubation
|
The Cormack-Lehane Grading System will be used to assess the laryngeal view obtained during videolaryngoscopic intubation.
The scale ranges from Grade I to Grade IV (minimum: Grade I; maximum: Grade IV), where higher grades indicate poorer laryngeal visualization and greater difficulty with tracheal intubation.
The recorded grade will be analyzed for its association with preoperative ultrasonographic airway measurements and the VIDIAC score.
|
During videolaryngoscopic intubation
|
Collaborators and Investigators
Sponsor
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
- GOKAEK 2026/11/19
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
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