- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07284251
C-MAC Video Laryngoscope for Double-Lumen Intubation
A Comparison of the D Blade and Mac Blade C-MAC Video Laryngoscope for Double-Lumen Endotracheal Intubation in Patients With Predicted Normal Airways
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Battalgazi
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Malatya, Battalgazi, Turkey (Türkiye), 44280
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
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.
In patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement
|
|
Active Comparator: Group M
once the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method
|
In patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement
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
|
|
Placebo Comparator: 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
|
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intubation time
Time Frame: 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
|
up to 10 minutes after intubation from recording
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yeliz tunc ozer, doctor, Inonu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- INU-AR-FAE-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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