Clinical Trial

Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation

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Summary
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.
Trial Details
NCT Number NCT07614529
Lead Sponsor Trakya University
Conditions Endobronchial Intubation, Double Lumen Tube Intubation, Thoracic Surgery, One Lung Ventillation (OLV)
Enrollment 180 participants
Start Date 2026-05-15
Primary Completion 2028-11-15 (estimated)
Study Completion 2029-01-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-29