An observational study in Head and Neck Cancer, sponsored by University Hospital Dubrava. Recruiting at 2 sites in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University Hospital Dubrava · Observational
This prospective observational cohort study will evaluate ultrasound-based airway measurements in adult patients with oncologic maxillofacial disease undergoing surgery under general anesthesia. The distance from the skin to the epiglottis (DSE) and the distance from the skin to the hyoid bone (DSHB) will be measured using preoperative airway ultrasonography and compared with corresponding measurements obtained from clinically indicated preoperative computed tomography (CT) images. The study will also investigate associations between ultrasound measurements and clinical characteristics related to airway management, including difficult tracheal intubation, difficult mask ventilation, trismus, tumor location, and previous radiotherapy
Adult patients with oncologic maxillofacial disease scheduled for elective surgery under general anesthesia will be prospectively enrolled.
Before induction of anesthesia, an ultrasound examination of the anterior neck will be performed by a trained anesthesiologist using a predefined measurement protocol. The distance from the skin to the epiglottis (DSE) and the distance from the skin to the hyoid bone (DSHB) will be recorded. Patient positioning and the ultrasound measurement technique will be standardized according to the study protocol.
Corresponding measurements will be obtained from preoperatively available CT examinations by a radiologist using predefined anatomical landmarks and measurement planes. No CT examination will be performed solely for research purposes.
The primary analysis will assess the agreement between ultrasound-based and CT-based DSE measurements. Agreement between ultrasound-based and CT-based DSHB measurements will be assessed as a secondary outcome.
Clinical airway characteristics and perioperative airway management data will be recorded. Difficult tracheal intubation will be evaluated using the Intubation Difficulty Scale (IDS), with an IDS score greater than 5 defining difficult intubation when the scale can be validly applied. Difficult mask ventilation will be classified according to the Han classification.
Patients for whom awake fiberoptic intubation is planned before induction because of a recognized difficult airway, including severe trismus or tumor-related anatomical distortion, will not undergo an attempt at conventional intubation solely for research purposes. These patients will be documented separately as having a pre-recognized difficult airway. IDS-based analyses will be restricted to patients in whom the scale can appropriately be assessed.
The study will not assign treatment or alter the planned airway management. All clinical decisions will remain the responsibility of the treating anesthesiologist.
2,409 studies on the registry are indexed under Head and Neck Neoplasms; 562 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 456 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Hospital Dubrava is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
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Patients with oncologic disease of the maxillofacial or head and neck region, scheduled for elective surgery under general anesthesia with planned airway management requiring tracheal intubation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
4. Availability of a preoperative CT examination suitable for the predefined airway measurements.
5. Written informed consent to participate.
Exclusion Criteria:
Agreement between ultrasound and CT measurements of DSE
Agreement between ultrasound measured and CT measured distance from skin to epiglottis
Time frame: Perioperative
Agreement between ultrasound-measured and CT-measured distance from the skin to the hyoid bone (DSHB)
Time frame: Perioperative
Association between ultrasound-measured DSE and difficult tracheal intubation, defined as an Intubation Difficulty Scale (IDS) score greater than 5
Time frame: Perioperative
Association between ultrasound-measured DSHB and difficult tracheal intubation, defined as an Intubation Difficulty Scale (IDS) score greater than 5
Time frame: Perioperative
Association between ultrasound-measured DSE and DSHB and difficult mask ventilation classified according to the Han classification
Time frame: Perioperative
Association between ultrasound-measured DSE and DSHB and preoperative clinical predictors of difficult intubation (maximal interincisal distance, Mallampati score, thyromental distance, neck circumference, neck mobility)
Time frame: Perioperative
Reproducibility of repeated ultrasound measurements of DSE and DSHB in the predefined subset of the first 10 participants
Time frame: Perioperative
Association between ultrasound-measured DSE and DSHB and tumor location and previous radiotherapy.
Time frame: Perioperative
Plan to share: No — Individual participant-level data will not be made publicly available. Study results may be disseminated in scientific publications using aggregated data. Data will be handled in accordance with applicable data protection requirements and the approved study protocol.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Hospital Dubrava