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Difficult AirwayNCT07813104

Comparative Analysis of a Preoperative Airway Ultrasound Protocol and Direct Laryngoscopy in Oncologic Surgery Patients

An observational study of Difficult Airway and Difficult Laryngoscopy, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective observational study evaluated the predictive performance of the Difficult Airway Evaluation with Sonography (DARES) protocol for identifying difficult laryngoscopy and other airway management difficulties in adult patients undergoing elective oncologic surgery. Read more about this study

Who is it for?
Ages 18 years and older
How many people
118 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2024to 15 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent surgery and preoperative airway ultrasonographic imaging at Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital in 2024-2025

Who may be able to join

  • Age ≥18 years Undergoing elective oncologic surgery ASA physical status I-III No history of previous head or neck surgery No history of radiotherapy to the head or neck region

Who cannot join

  • Age <18 years Emergency surgery ASA physical status IV Previous head or neck surgery Previous radiotherapy to the head or neck region Missing data in patient study forms
  • Patients scheduled to undergo head and neck surgery were not excluded if they had no history of previous head or neck surgery or radiotherapy to the head and neck region.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi

    Ankara, 06170

Other trials in Turkey (Türkiye)

About this study

This prospective observational study evaluated the predictive performance of the Difficult Airway Evaluation with Sonography (DARES) protocol for identifying difficult laryngoscopy and other airway management difficulties in adult patients undergoing elective oncologic surgery.

Preoperative airway ultrasonography was performed together with conventional clinical airway assessment. Ultrasound parameters included the distance from skin to epiglottis (DSE), hyomental distance (HMD) measured in different head positions, hyomental distance ratios (HMDR1 and HMDR2), and tongue thickness (TT). Conventional airway assessment parameters were also recorded.

Read more

The primary objective was to evaluate the ability of ultrasound-derived airway parameters to predict difficult laryngoscopy, defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4) during direct laryngoscopy, and to compare their predictive performance with conventional clinical airway assessment methods.

Secondary objectives included evaluating the relationship between ultrasound parameters and difficult mask ventilation, assessed using the Han scale; investigating their relationship with difficulties or complications encountered during extubation; and exploring differences in airway ultrasound parameters and their predictive performance across oncologic patient subgroups.

Read the detailed description

This prospective observational cohort study evaluated the predictive performance of the previously described Difficult Airway Evaluation with Sonography (DARES) protocol in adult patients undergoing elective oncologic surgery.

The study was conducted at the Department of Anesthesiology and Reanimation, Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. A total of 118 participants were enrolled. All participants underwent preoperative airway assessment and perioperative airway management according to routine clinical practice.

The DARES protocol incorporates selected sonographic parameters used for difficult airway assessment. Preoperative airway ultrasonography was performed in the premedication unit using a Mindray® ultrasound system. Sonographic measurements included skin-to-epiglottis distance (DSE), hyomental distance (HMD) measured in different head positions, hyomental distance ratios (HMDR1 and HMDR2), and tongue thickness (TT). DSE was measured using a 5-14 MHz linear probe, while HMD and TT were measured using a 4-10 MHz curvilinear probe. Ultrasound examinations were performed by a single trained investigator to minimize interobserver variability.

In addition to the ultrasonographic measurements, conventional clinical airway assessment parameters were recorded. Mallampati classification was assessed preoperatively. Mask ventilation difficulty was evaluated using the Han scale, and laryngoscopic view was assessed using the Cormack-Lehane grading system during direct laryngoscopy. Difficult laryngoscopy was defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4). Difficulties and complications encountered during extubation were also prospectively recorded.

For patient safety, the results of the preoperative ultrasonographic airway assessment were made available to the anesthesiologist responsible for airway management, allowing appropriate precautions to be taken when difficult airway management was anticipated. Therefore, the anesthesiologist performing airway management was not blinded to the ultrasound findings. To reduce measurement-related observer variability, preoperative ultrasound measurements and intraoperative airway assessments were performed and recorded by different individuals.

The primary objective was to evaluate the predictive performance of ultrasound-derived airway parameters for difficult laryngoscopy and to compare their performance with conventional clinical airway assessment. Secondary evaluations included the relationship between sonographic airway parameters and mask ventilation difficulty, difficulties or complications encountered during extubation, and exploratory analyses according to oncologic tumor type.

Collected data included age, sex, body mass index, comorbidities, oncologic history, previous surgery and radiotherapy, Mallampati classification, previous anesthesia history, American Society of Anesthesiologists (ASA) physical status, Cormack-Lehane grade, Han mask ventilation grade, anesthesia type and duration, difficulties encountered during mask ventilation, and difficulties or complications encountered during extubation. Data were recorded using a dedicated case report form together with standard anesthesia records.

Statistical analyses were performed using IBM SPSS Statistics version 25.0. The distribution of continuous variables was assessed using the Shapiro-Wilk or Kolmogorov-Smirnov test, as appropriate, and homogeneity of variances was assessed using Levene's test. Continuous variables were summarized using appropriate descriptive statistics according to their distribution, while categorical variables were presented as frequencies and percentages.

Comparisons between two independent groups were performed using the independent-samples t-test or Mann-Whitney U test, as appropriate. Comparisons involving more than two groups were performed using one-way analysis of variance (ANOVA) or the Kruskal-Wallis test. Categorical variables were compared using the Pearson chi-square test or Fisher's exact test, as appropriate.

The discriminatory performance of sonographic airway parameters, including DSE, HMD, HMDR1, HMDR2, and TT, was evaluated using receiver operating characteristic (ROC) curve analysis. Areas under the ROC curve (AUCs) were calculated, and optimal cutoff values were determined using the Youden Index. Diagnostic performance measures, including sensitivity, specificity, positive predictive value, and negative predictive value, were calculated where appropriate. Associations between continuous variables were evaluated using appropriate correlation analyses. A two-sided p value <0.05 was considered statistically significant.

No study-specific therapeutic intervention was performed, and participation did not require deviation from routine perioperative airway management.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association Between Preoperative Airway Ultrasound Measurements and Cormack-Lehane Grade During Direct Laryngoscopy

    The association between preoperative airway ultrasound measurements and laryngoscopic difficulty was assessed. Ultrasound measurements included skin-to-epiglottis distance (DSE, measured in millimeters), hyomental distance (HMD, measured in millimeters) in neutral, ramped, and maximally extended head positions, hyomental distance ratios (HMDR1 and HMDR2, dimensionless ratios), and tongue thickness (TT, measured in millimeters). Laryngoscopic difficulty was assessed during direct laryngoscopy using the Cormack-Lehane grading system (grades 1, 2a, 2b, 3, and 4). Difficult laryngoscopy was defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4).

    Measured: Preoperative assessment through direct laryngoscopy during induction of general anesthesia

Secondary outcomes (2)
  1. Association Between Preoperative Airway Ultrasound Parameters and Difficult Mask Ventilation Assessed Using the Han Scale

    The association between preoperative airway ultrasound measurements and difficult mask ventilation was evaluated. Ultrasound parameters included skin-to-epiglottis distance (DSE, measured in millimeters), hyomental distance (HMD, measured in millimeters), hyomental distance ratios (HMDR1 and HMDR2, dimensionless ratios), and tongue thickness (TT, measured in millimeters). Mask ventilation difficulty was assessed using the Han scale (grades 1-4). Difficult mask ventilation was defined as Han grade 3 or 4. Ultrasound measurements were compared between participants with and without difficult mask ventilation.

    Measured: During induction of general anesthesia

  2. Association Between Difficult Laryngoscopy and Extubation Difficulties or Complications

    Difficult laryngoscopy was assessed using the Cormack-Lehane grading system during direct laryngoscopy and was defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4). Participants were classified as having either difficult or non-difficult laryngoscopy. Extubation difficulties or complications were prospectively recorded as present or absent during extubation. The proportion of participants experiencing extubation difficulties or complications was compared between the difficult and non-difficult laryngoscopy groups.

    Measured: Postoperative assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Oct 2024
  3. Primary completion15 May 2025
  4. Study completion15 Jul 2025

Resources

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
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07813104
Sponsor's protocol ID
AbdurrahmanYAOTRH-AR-TA-01
Status last verified
Sep 2026
First submitted
22 May 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data including all ultrasonographic measurement values and the results of comparative analyses (e.g., difficult laryngoscopy scores, Cormack-Lehane classification, demographic findings)

Questions about this trial

What is this clinical trial studying?

An observational study of Difficult Airway and Difficult Laryngoscopy, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association Between Preoperative Airway Ultrasound Measurements and Cormack-Lehane Grade During Direct Laryngoscopy (time frame: Preoperative assessment through direct laryngoscopy during induction of general anesthesia). 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 10 Sep 2026.

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