C-MAC Video Laryngoscope for Double-Lumen Intubation

NCT07284251 | Completed

• 1 other identifier: INU-AR-FAE-01
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

. The study aimed to compare the C-MAC D-Blade (Group D) and the C-MAC Macintosh blade (Group M) with the conventional direct laryngoscopy macintosh blade (Group DL) in patients with predicted normal airways undergoing thoracic surgery requiring double lumen tube (DLT) placement.

Conditions

Device Performance

Outcome Measures

Primary Outcomes (1)

• intubation time

  DLT insertion time was defined as the period from when the intubation device passed the patient's lips until three complete end-tidal carbon dioxide cycles were displayed on the monitor

  up to 10 minutes after intubation from recording

Study Arms (3)

Group D blade

ACTIVE COMPARATOR

DLT (with the stylet in place) was molded along the blade convexity, and sequential rotation was performed for insertion. After the bronchial lumen tip engaged the glottis, the stylet was removed, and the DLT was rotated 180° counterclockwise to facilitate passage of the bronchial cuff. The DLT was then rotated 90° clockwise to ensure it entered the left main bronchus

Device: C-MAC Macintosh blade Video Laryngoscope; Device: DİRECT Laryngoscopy

Group M

ACTIVE COMPARATOR

once the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method

Device: DİRECT Laryngoscopy; Device: D blade CMac videolaryngoscopy

Group DL (Direct laryngoscopy macintosch blade, conventional . placebo)

PLACEBO COMPARATOR

once the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method

Device: C-MAC Macintosh blade Video Laryngoscope; Device: D blade CMac videolaryngoscopy

Interventions

C-MAC Macintosh blade Video Laryngoscope DEVICE

videolaryngoscopes have been increasingly used in thoracic surgery, particularly in patients with difficult airways, as they enhance visualization of laryngeal structures and facilitate lung separationThe D-blade and Mac blade are adapted for use with the C-MAC system.10 The C-MAC Mac and D-blade may be a viable alternative to direct laryngoscopy with the Mac blade in routine practice.

Group D blade; Group DL (Direct laryngoscopy macintosch blade, conventional . placebo)

DİRECT Laryngoscopy DEVICE

In patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement

Group D blade; Group M

D blade CMac videolaryngoscopy DEVICE

videolaryngoscopes have been increasingly used in thoracic surgery, particularly in patients with difficult airways, as they enhance visualization of laryngeal structures and facilitate lung separation

Group DL (Direct laryngoscopy macintosch blade, conventional . placebo); Group M

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American Society of Anesthesiologists (ASA) I to III,
• Patients requiring one-lung ventilation via DLT intubation

You may not qualify if:

• Patients with a history of difficult endotracheal intubation or mask ventilation,
• Patients with severe pulmonary ventilation dysfunction,
• Patients with a risk of pulmonary aspiration patients

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

inonu University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Study Officials

• Yeliz tunc ozer, doctor

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Doctor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 16, 2025
• Study Start: June 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)