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

NCT07813104 | Completed

• 1 other identifier: AbdurrahmanYAOTRH-AR-TA-01
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Difficult Airway; Difficult Laryngoscopy; Oncologic Surgery; Airway Management; DARES Protocol

Outcome Measures

Primary Outcomes (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).

  Preoperative assessment through direct laryngoscopy during induction of general anesthesia

Secondary Outcomes (2)

• Association Between Preoperative Airway Ultrasound Parameters and Difficult Mask Ventilation Assessed Using the Han Scale

  During induction of general anesthesia

• Association Between Difficult Laryngoscopy and Extubation Difficulties or Complications

  Postoperative assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi

Ankara, 06170, Turkey (Türkiye)

Location

Study Officials

• Sencer Uçar, MD

  Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

• Tuğba Aşkın, MD

  Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comparative Analysis of a Preoperative Airway Ultrasound Protocol and Direct Laryngoscopy in Oncologic Surgery Patients

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: September 10, 2026
• Study Start: October 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available within 12 months after publication of the primary results in a peer-reviewed journal.
• Access Criteria: Researchers must submit a written data request form and study protocol. Approval by the study steering committee is required.

Locations

TU (1)