This is a prospective, randomized, single-center, three-arm, open-label, low-risk medical device clinical study conducted at the Department of Anesthesiology and Reanimation, Trakya University Medical Faculty.
The study aims to compare the efficacy, safety, and clinical usability of three laryngoscopy methods for double-lumen endotracheal tube (DLT) intubation in patients undergoing elective thoracic surgery requiring one-lung ventilation: (i) C-MAC hyperangulated (D-blade) videolaryngoscopy, (ii) C-MAC Macintosh blade videolaryngoscopy, and (iii) direct Macintosh laryngoscopy.
The primary outcome is the total time to successful DLT placement (in seconds), defined as the interval from the end of mask ventilation to fiberoptic bronchoscopic confirmation of correct tube position. Secondary outcomes include glottic visualization quality (POGO score and Cormack-Lehane grade), intubation difficulty (Intubation Difficulty Scale), number of intubation attempts, need for auxiliary maneuvers, intubation-related complications, malposition rate, and postoperative airway symptoms (sore throat, dysphonia) assessed at 1, 6, and 24 hours postoperatively.
Eligible patients are adults (≥18 years), ASA class I-III, scheduled for elective thoracic surgery requiring one-lung ventilation. Patients with anticipated difficult airway, emergency surgery, pregnancy, or prior upper airway surgery are excluded. A total of 180 patients will be enrolled and randomized 1:1:1 into three groups (60 per group) using computer-generated block randomization.
Age 18 years or older
Written informed consent obtained prior to surgery
ASA physical status class I, II, or III
Scheduled for elective thoracic surgery requiring one-lung ventilation and double-lumen endobronchial intubation
Age under 18 years
Refusal or inability to provide informed consent
ASA physical status class IV or above
Emergency surgery
Parallel
C-MAC Hyperangulated D-Blade Videolaryngoscopy
DeviceDouble-lumen endotracheal tube intubation performed using the Storz C-MAC hyperangulated D-blade videolaryngoscope. The D-blade provides an acutely angled viewing geometry with high-resolution video transmission to an external monitor. The DLT stylet is shaped to match the D-blade curvature prior to intubation. All devices are CE-marked and used in accordance with the manufacturer's intended purpose.
C-MAC Macintosh Blade Videolaryngoscopy
DeviceDouble-lumen endotracheal tube intubation performed using the Storz C-MAC Macintosh blade videolaryngoscope. The Macintosh geometry blade enables both direct and video-assisted laryngoscopy while preserving standard hand mechanics. The DLT stylet is shaped to match the Macintosh blade curvature prior to intubation. All devices are CE-marked and used in accordance with the manufacturer's intended purpose.
Direct Macintosh Laryngoscopy
DeviceDouble-lumen endotracheal tube intubation performed using a standard direct Macintosh laryngoscope without video assistance. This represents current standard clinical practice for DLT intubation in thoracic surgery and serves as the active comparator. The DLT stylet is shaped to match the Macintosh blade curvature prior to intubation. All devices are CE-marked and used in accordance with the manufacturer's intended purpose.
Total time to successful double-lumen endotracheal tube placement-seconds
Total intubation time in seconds, defined as the interval from cessation of mask ventilation to the appearance of the first complete end-tidal CO2 waveform confirming successful endotracheal tube placement. Final tube position is verified by fiberoptic bronchoscopy. If the tube is not placed properly, fiberoptic bronchoscopy is used to correct the position. Time is recorded continuously for each participant using a stopwatch. In cases requiring multiple intubation attempts, cumulative time across all attempts is recorded. Cases requiring activation of the difficult airway algorithm after three failed attempts are classified as intubation failure and analyzed separately.
Glottic visualization quality - POGO score
Percentage of Glottic Opening (POGO) score assessed by the operator immediately upon laryngoscope insertion, expressed as a percentage from 0% (no glottic structures visible) to 100% (entire glottic opening visible).
Glottic visualization quality - Cormack-Lehane grade
Cormack-Lehane laryngoscopic grade (I, II, III, IV) assessed by the operator immediately upon laryngoscope insertion and recorded as an ordinal variable.
Intubation difficulty - Intubation Difficulty Scale (IDS)
Intubation Difficulty Scale (IDS) score calculated after each intubation, incorporating number of attempts, number of operators, number of techniques used, Cormack-Lehane grade, lifting force, laryngeal pressure, and vocal cord position. Higher scores indicate greater intubation difficulty.
Number of intubation attempts
Total number of intubation attempts required for successful DLT placement, defined as each insertion of the tube past the teeth. Cases requiring more than three attempts are classified as intubation failure and managed according to the institutional difficult airway algorithm.
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