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

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.

Conditions

• Endobronchial Intubation
• Double Lumen Tube Intubation
• Thoracic Surgery
• One Lung Ventillation (OLV)

Interventions

DEVICE

C-MAC Hyperangulated D-Blade Videolaryngoscopy

Double-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.

DEVICE

C-MAC Macintosh Blade Videolaryngoscopy

Double-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.

DEVICE

Direct Macintosh Laryngoscopy

Double-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.

Sponsors & Collaborators

• Trakya University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2028-11-15

Completion

2029-01-15