Comparison of Airway Ultrasonography and Laryngoscopy Methods in Obese Patients

NCT07482436 | Recruiting DMC

• 1 other identifier: TrabzonMF
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Correlation of Difficult Airway Markers With Ultrasonographic Measurements in Obese Patients

Keywords

laryngoscopy; difficult airway; obese patients; airway ultrasonography

Outcome Measures

Primary Outcomes (2)

• Prediction of difficult tracheal intubation

  Airway ultrasonographic parameters and conventional airway assessment scores will be evaluated to determine their ability to predict difficult tracheal intubation in obese patients undergoing elective surgery under general anesthesia. Difficult tracheal intubation will be defined using the Intubation Difficulty Scale (IDS).

  Periprocedural (during tracheal intubation)

• Tracheal intubation success according to laryngoscope type

  Tracheal intubation success will be compared among patients randomized to Macintosh laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope during tracheal intubation in obese patients undergoing elective surgery under general anesthesia.

  During the tracheal intubation procedure

Secondary Outcomes (6)

• Glottic visualization time

  Periprocedural (during tracheal intubation)

• Endotracheal intubation time

  Periprocedural (during tracheal intubation)

• Hemodynamic response to tracheal intubation

  Periprocedural

• Postoperative airway ultrasonographic measurements

  30 minutes after extubation

• Airway-related postoperative complications

  From intubation to 30 minutes postoperatively

Study Arms (3)

Besdata Videolaryngoscope

EXPERIMENTAL

Participants randomized to this arm will undergo tracheal intubation using the Besdata videolaryngoscope under standardized general anesthesia induction.

Procedure: Airway ultrasonography; Device: Besdata Videolaryngoscope Intubation

Tuoren Videolaryngoscope

EXPERIMENTAL

Participants randomized to this arm will undergo tracheal intubation using the Tuoren videolaryngoscope under standardized general anesthesia induction.

Procedure: Airway ultrasonography; Device: Tuoren Videolaryngoscope Intubation

Macintosh Laryngoscope

ACTIVE COMPARATOR

Participants randomized to this arm will undergo tracheal intubation using a conventional Macintosh direct laryngoscope under standardized general anesthesia induction.

Procedure: Airway ultrasonography; Device: Macintosh Laryngoscope Intubation

Interventions

Airway ultrasonography PROCEDURE

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.

Besdata Videolaryngoscope; Macintosh Laryngoscope; Tuoren Videolaryngoscope

Macintosh Laryngoscope Intubation DEVICE

Endotracheal intubation will be performed using a conventional Macintosh direct laryngoscope under standardized general anesthesia induction.

Macintosh Laryngoscope

Tuoren Videolaryngoscope Intubation DEVICE

Endotracheal intubation will be performed using the Tuoren videolaryngoscope under standardized general anesthesia induction.

Tuoren Videolaryngoscope

Besdata Videolaryngoscope Intubation DEVICE

Endotracheal intubation will be performed using the Besdata videolaryngoscope under standardized general anesthesia induction.

Besdata Videolaryngoscope

Eligibility Criteria

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

You may qualify if:

• Patients who have given their consent
• Patients who underwent surgery under general anesthesia
• Patients over eighteen years of age
• Patients with an American Society of Anesthesiologists (ASA) physical status classification of I-II-III
• Patients with a body mass index (BMI) of 30 kg/m2 or higher
• Patients whose surgery lasts between 60 and 150 minutes
• Patients who underwent surgery under elective conditions will be included.

You may not qualify if:

• Patients who do not consent,
• those undergoing head and neck surgery,
• those to be operated on in the prone position,
• uncooperative patients (patients with whom communication is not possible),
• those with craniofacial anomalies,
• patients operated on in emergency situations will be excluded from the study.

Sponsors & Collaborators

• Trabzon Kanuni Education and Research Hospital: lead

Study Sites (1)

Trabzon University Faculty of Medicine Kanuni Training and Research Hospital

Trabzon, 61040, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Accuracy of airway ultrasound parameters to predict difficult airway using the LEMON criteria as a reference: A cross-sectional diagnostic accuracy study (DOI: 10.4103/2452-2473.366484 )

  BACKGROUND

• Ultrasound measurements for evaluation of changes in upper airway during anaesthesia induction and prediction difficult laryngoscopy: a prospective observational study ( doi.org/10.1038/s41598-022-21695-2)

  BACKGROUND

• Comparison of Tracheal Intubation Using King Vision (Non-channeled Blade) and Tuoren Video Laryngoscopes in Patients With Cervical Spine Immobilization by Manual In-Line Stabilization: A Randomized Clinical Trial (doi: 10.7759/cureus.43471)

  BACKGROUND

Central Study Contacts

Ezgi Günaydın, MD

CONTACT

+905336834198; ezgunaydin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: Participants will be randomized into three parallel groups to undergo tracheal intubation using either a Macintosh laryngoscope, Tuoren videolaryngoscope, or Besdata videolaryngoscope. Each participant will receive only one assigned intervention.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 19, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)