Trabzon University Faculty of Medicine Kanuni Training and Research Hospital
Trabzon, 61040, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07482436
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Trabzon, 61040, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Endotracheal intubation will be performed using a conventional Macintosh direct laryngoscope under standardized general anesthesia induction.
Endotracheal intubation will be performed using the Tuoren videolaryngoscope under standardized general anesthesia induction.
Endotracheal intubation will be performed using the Besdata videolaryngoscope under standardized general anesthesia induction.
Time frame: Periprocedural (during 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).
Time frame: During the tracheal intubation procedure
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.
Time frame: Periprocedural (during tracheal intubation)
Glottic visualization time will be defined as the time from passage of the laryngoscope blade past the lips until the first visualization of the vocal cords during laryngoscopy. Glottic visualization time will be compared among the Macintosh laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope groups.
Time frame: Periprocedural (during tracheal intubation)
Endotracheal intubation time will be defined as the time from passage of the laryngoscope blade past the lips until confirmation of successful tracheal intubation by capnography. Intubation time will be compared among the Macintosh laryngoscope, Tuoren videolaryngoscope, and Besdata videolaryngoscope groups.
Time frame: Periprocedural
Hemodynamic parameters will be recorded before anesthesia induction, 1 minute after induction, at 1, 3, 5, and 10 minutes after tracheal intubation, and immediately before extubation to evaluate the effects of different laryngoscopy techniques.
Time frame: 30 minutes after extubation
Airway ultrasonography will be repeated 30 minutes after extubation in the recovery unit and compared with preoperative ultrasonographic measurements.
Time frame: From intubation to 30 minutes postoperatively
Airway-related complications including sore throat, hoarseness, laryngospasm, bronchospasm, hypoxemia, esophageal intubation, and oral trauma will be recorded.
Time frame: Immediately after tracheal intubation
Anesthesiologist satisfaction with the laryngoscope will be evaluated using a 6-item questionnaire based on a 5-point Likert scale (1 = very poor, 5 = excellent). The questionnaire will assess the ease of laryngoscope insertion, quality of glottic visualization, ease of endotracheal tube placement, device handling, need for additional maneuvers, and overall operator satisfaction.
Contact information is provided by the study sponsor or research team.
Trabzon Kanuni Education and Research Hospital
Other
The Effect of Preoperative and Postoperative Airway Ultrasonography and Different Laryngoscope Uses on Intubation Success and Postoperative Complications in Obese Patients
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