C-MAC Video Laryngoscope for Double-Lumen Intubation

NCT ID: NCT07284251

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-09-30

Brief Summary

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. 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.

Detailed Description

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The double-lumen tracheal tube (DLT) is the standard device for achieving one-lung ventilation in thoracic surgery. Compared to a single-lumen endotracheal tube, the DLT is longer, stiffer, and has a larger external diameter, making its insertion more challenging. Recently, 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.However, the role of the videolaryngoscope in DLT intubation remains unclear due to the larger size of the DLT and the discrepancy between the curves of the DLT and the videolaryngoscope blade, which can affect vocal cord visualization and, consequently, intubation success.

Videolaryngoscopes can be classified as standard or hyperangulated based on blade angulation. The results of clinical studies on hyperangulated videolaryngoscopes for DLT placement have been inconsistent, particularly regarding intubation time. While some hyperangulated videolaryngoscopes have demonstrated superiority over the macintosh (Mac) blade laryngoscope in normal airway patients, others have not. These discrepancies may stem from the use of manikins in some studies, variations in clinician experience with videolaryngoscopes, or differences in intubation techniques.

In patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement. The C-MAC videolaryngoscope is designed based on the Mac blade and has been associated with improved laryngeal visualization and reduced need for additional maneuvers to facilitate intubation. The D-blade and Mac blade are adapted for use with the C-MAC system. The C-MAC Mac and D-blade may be a viable alternative to direct laryngoscopy with the Mac blade in routine practice.

This randomized controlled study aimed to compare the C-MAC D-Blade and the C-MAC Mac blade with the conventional direct laryngoscopy Mac blade in patients with predicted normal airways undergoing thoracic surgery requiring DLT placement. The primary outcome measure was intubation time. Additional parameters assessed included exposure time, the ease of intubation, number of laryngoscopy attempts, and maneuvers.

Conditions

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Device Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group D blade

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

Group Type ACTIVE_COMPARATOR

C-MAC Macintosh blade Video Laryngoscope

Intervention Type 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.

DİRECT Laryngoscopy

Intervention Type DEVICE

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

Group M

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

Group Type ACTIVE_COMPARATOR

DİRECT Laryngoscopy

Intervention Type DEVICE

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

D blade CMac videolaryngoscopy

Intervention Type 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)

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

Group Type PLACEBO_COMPARATOR

C-MAC Macintosh blade Video Laryngoscope

Intervention Type 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.

D blade CMac videolaryngoscopy

Intervention Type 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

Interventions

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C-MAC Macintosh blade Video Laryngoscope

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.

Intervention Type DEVICE

DİRECT Laryngoscopy

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

Intervention Type DEVICE

D blade CMac videolaryngoscopy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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FERAY AKGUL ERDIL

Clinical Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeliz tunc ozer, doctor

Role: PRINCIPAL_INVESTIGATOR

Inonu University

Locations

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inonu University

Malatya, Battalgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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INU-AR-FAE-01

Identifier Type: -

Identifier Source: org_study_id