NCT07482436

Comparison of Airway Ultrasonography and Laryngoscopy Methods in Obese Patients

The Effect of Preoperative and Postoperative Airway Ultrasonography and Different Laryngoscope Uses on Intubation Success and Postoperative Complications in Obese Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Trabzon Kanuni Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study was to examine the relationship between classical markers used in assessing difficult airway management in obese patients (Mallampati score, thyromental distance, sternomental distance, neck circumference measurement) and ultrasonographic parameters (vocal cord mobility, glottic opening, hyomental distance, skin-epiglottic distance, and peri-epiglottic space-epiglottic-vocal cord ratio), to compare the effects of these parameters on predicting difficult intubation, and to investigate the effects of different laryngoscopy methods on intubation success and peroperative respiratory complications. The secondary objective of the study is to investigate the effects of different laryngoscopy methods on hemodynamic responses to intubation. Participants' gender, age, height, weight, BMI, ASA physical status classification, smoking status, comorbidities, STOP-BANG and LEMON scores will be recorded. The glottic score percentage (POGO score), glottic visualization time, endotracheal intubation time, use of assistive maneuvers, and Intubation Difficulty Scale (IDS) parameters will be compared according to the laryngoscopy methods used. Participants must meet the following criteria: * Consent given by the patient * Operated under general anesthesia * Over 18 years of age * American Society of Anesthesiologists (ASA) physical status classification I-II-III * Body mass index (BMI) of 30 kg/m2 or higher * Operation duration between 60-150 minutes * Patients undergoing elective surgery.

Detailed description

Unanticipated morbidity related to difficult airway management remains a major concern for anesthesiologists. One of the primary reasons is the high interobserver variability and limited predictive power of currently used bedside airway assessment tests. The use of more objective and reproducible measurement techniques may improve intubation success rates and allow better preparation in cases of anticipated difficult airway. Ultrasonography (USG) is a rapid, non-invasive, portable imaging modality that provides both static and dynamic real-time visualization. Airway ultrasonography is increasingly used in operating rooms, intensive care units, and emergency departments for detailed assessment of airway anatomy. It provides valuable information regarding upper airway structures, soft tissues of the head and neck, and pretracheal anatomy. Preoperative airway assessment is the first and most critical step in preventing anesthesia-related airway complications. Recent evidence suggests that incorporating airway ultrasound into routine pre-anesthetic evaluation may improve the prediction of difficult airway compared to conventional clinical assessments alone. With the global increase in obesity prevalence, anesthesiologists are encountering a growing number of obese patients in daily practice. Numerous studies have identified male sex, advanced age, increased neck circumference, higher body mass index (BMI), obstructive sleep apnea syndrome, higher Mallampati score, higher ASA score, and shorter thyromental distance as predictors of difficult intubation in obese patients. Despite these known predictors, the rate of unanticipated difficult intubation remains considerable. Videolaryngoscopes have demonstrated high success rates in both anticipated and unanticipated difficult airway scenarios. These devices improve glottic visualization and may increase first-pass intubation success while reducing airway-related complications. In obese patients, videolaryngoscopy may further enhance intubation safety and perioperative outcomes. This randomized prospective study aims to compare the predictive value of conventional difficult airway markers (Mallampati score, thyromental distance, sternomental distance, and neck circumference) with airway ultrasonographic parameters (vocal cord mobility, glottic opening, hyomental distance, skin-to-epiglottis distance, and peri-epiglottic space-epiglottis-vocal cord ratio) in obese patients undergoing elective surgery under general anesthesia. Additionally, the study will evaluate the effects of three different laryngoscopy methods (Macintosh direct laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope) on intubation success, perioperative respiratory complications, and hemodynamic responses. Postoperative airway ultrasonography will be performed to assess potential airway-related complications.

Conditions

• Correlation of Difficult Airway Markers With Ultrasonographic Measurements in Obese Patients

Interventions

Type	Name	Description
PROCEDURE	Airway ultrasonography	Preoperative airway ultrasonography will be performed in the waiting area before surgery to evaluate upper airway structures including vocal cord mobility, glottic opening, hyomental distance, skin-to-epiglottis distance, and peri-epiglottic space-epiglottis-vocal cord ratio. Measurements will be obtained with a Mindray Consona N7 ultrasound device while the patient is in the supine position. Each measurement will be performed three times and the average value will be recorded. Postoperative airway ultrasonography will be repeated at 30 minutes in the recovery unit.
DEVICE	Macintosh Laryngoscope Intubation	Endotracheal intubation will be performed using a conventional Macintosh direct laryngoscope under standardized general anesthesia induction.
DEVICE	Tuoren Videolaryngoscope Intubation	Endotracheal intubation will be performed using the Tuoren videolaryngoscope under standardized general anesthesia induction.
DEVICE	Besdata Videolaryngoscope Intubation	Endotracheal intubation will be performed using the Besdata videolaryngoscope under standardized general anesthesia induction.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Turkey (Türkiye)