Device Performance
Conditions
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.
Detailed 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.
Interventions
DEVICEC-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.
DEVICEDİRECT Laryngoscopy
In patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement
DEVICED 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
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intubation time | up to 10 minutes after intubation from recording | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed