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