C-MAC Video Laryngoscope for Double-Lumen Intubation

Inonu University

Status

Completed

Conditions

Device Performance

Treatments

Device: DİRECT Laryngoscopy

Device: D blade CMac videolaryngoscopy

Device: C-MAC Macintosh blade Video Laryngoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT07284251

INU-AR-FAE-01

Details and patient eligibility

About

. 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.

Full description

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.

Enrollment

252 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

252 participants in 3 patient groups, including a placebo group

Group D blade

Active Comparator group

Description:

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

Treatment:

Device: C-MAC Macintosh blade Video Laryngoscope

Device: DİRECT Laryngoscopy

Group M

Active Comparator group

Description:

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

Treatment:

Device: D blade CMac videolaryngoscopy

Device: DİRECT Laryngoscopy

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

Placebo Comparator group