Comparison of Airway Ultrasonography and Laryngoscopy Methods in Obese Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrabzon Kanuni Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Airway ultrasonography

    Procedure/Surgery

    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.

  • Macintosh Laryngoscope Intubation

    Device

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

  • Tuoren Videolaryngoscope Intubation

    Device

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

  • Besdata Videolaryngoscope Intubation

    Device

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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Besdata VideolaryngoscopeExperimental treatment 2 interventions
Group B: Tuoren VideolaryngoscopeExperimental treatment 2 interventions
Group C: Macintosh LaryngoscopeActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Periprocedural (during tracheal intubation)
2

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.

Time frame
During the tracheal intubation procedure

Secondary outcomes

1

Glottic visualization time

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)
2

Endotracheal intubation time

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 (during tracheal intubation)
3

Hemodynamic response to tracheal intubation

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
Periprocedural
4

Postoperative airway ultrasonographic measurements

Airway ultrasonography will be repeated 30 minutes after extubation in the recovery unit and compared with preoperative ultrasonographic measurements.

Time frame
30 minutes after extubation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.