Difficult AirwayNCT07694154
Ultrasonographic Airway Assessment and VIDIAC Score
An observational study of Difficult Airway and Difficult Intubation, run by Samsun University.
Trial summary
This prospective observational study aims to evaluate the relationship between preoperative ultrasonographic airway measurements and the Video-Intubation Difficulty Assessment Classification (VIDIAC) score in adult patients undergoing endotracheal intubation under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Difficult Airway, Difficult Intubation, Videolaryngoscopic Intubation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 22 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18-80 years who are scheduled to undergo elective surgical procedures requiring endotracheal intubation under general anesthesia at Samsun City Hospital. Eligible patients with ASA physical status I-III who provide written informed consent and meet all inclusion criteria will be consecutively enrolled in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
This prospective observational study aims to evaluate the relationship between preoperative ultrasonographic airway measurements and the Video-Intubation Difficulty Assessment Classification (VIDIAC) score in adult patients undergoing endotracheal intubation under general anesthesia. The study will investigate whether airway ultrasound parameters can predict difficult videolaryngoscopic intubation and assess their association with the Cormack-Lehane classification, intubation time, and other airway management outcomes.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relationship between preoperative ultrasonographic airway measurements and the VIDIAC score.
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.
Measured: During videolaryngoscopic intubation
Secondary outcomes (7)
Incidence of Difficult 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.
Measured: During videolaryngoscopic intubation
Cormack-Lehane Grade
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.
Measured: During videolaryngoscopic intubation
Intubation Time
The duration of videolaryngoscopic intubation, measured from insertion of the videolaryngoscope into the oral cavity until successful placement of the endotracheal tube.
Measured: During videolaryngoscopic intubation
First-Attempt Intubation Success Rate
The proportion of patients successfully intubated on the first videolaryngoscopic attempt without the need for additional intubation attempts.
Measured: During videolaryngoscopic intubation
Requirement for Additional Airway Maneuvers
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.
Measured: During videolaryngoscopic intubation
Occurrence of Oxygen Desaturation
The occurrence of oxygen desaturation during videolaryngoscopic intubation, defined as a decrease in peripheral oxygen saturation (SpO₂) below 90%.
Measured: During videolaryngoscopic intubation
Number of Intubation Attempts
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.
Measured: During videolaryngoscopic intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start22 Jun 2026 (estimated)
- Primary completion22 Jan 2027 (estimated)
- Study completion22 Jan 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694154
- Sponsor's protocol ID
- GOKAEK 2026/11/19
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07694154
- Acronym / sponsor ID
- GOKAEK 2026/11/19
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 9 Jul 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 relationship between preoperative ultrasonographic airway measurements and the Video-Intubation Difficulty Assessment Classification (VIDIAC) score in adult patients undergoing endotracheal intubation under general anesthesia. The study will investigate whether airway ultrasound parameters can predict difficult videolaryngoscopic intubation and assess their association with the Cormack-Lehane classification, intubation time, and other airway management outcomes.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18-80 years who are scheduled to undergo elective surgical procedures requiring endotracheal intubation under general anesthesia at Samsun City Hospital. Eligible patients with ASA physical status I-III who provide written informed consent and meet all inclusion criteria will be consecutively enrolled in the study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Known airway abnormalities.
- Head and neck tumors.
- Patients with a tracheostomy.
- Pregnant patients.
- Emergency surgical procedures.
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
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.
7 secondary outcomes
Incidence of Difficult Videolaryngoscopic Intubation
Time frame: During videolaryngoscopic intubation
Cormack-Lehane Grade
Time frame: During videolaryngoscopic intubation
Intubation Time
Time frame: During videolaryngoscopic intubation
First-Attempt Intubation Success Rate
Time frame: During videolaryngoscopic intubation
Requirement for Additional Airway Maneuvers
Time frame: During videolaryngoscopic intubation
Occurrence of Oxygen Desaturation
Time frame: During videolaryngoscopic intubation
Number of Intubation Attempts
Time frame: During videolaryngoscopic intubation
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 21 Jul 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway and Difficult Intubation, run by Samsun University.
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 4 inclusion and 7 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hatice Selçuk Kuşderci (0 505 215 98 96, drkusderci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the relationship between preoperative ultrasonographic airway measurements and the VIDIAC score. (time frame: During videolaryngoscopic intubation). 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 21 Jul 2026.