Device PerformanceNCT07284251
C-MAC Video Laryngoscope for Double-Lumen Intubation
A study testing C-MAC Macintosh blade Video Laryngoscope, DİRECT Laryngoscopy and D blade CMac videolaryngoscopy in people with Device Performance, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Device Performance
- What is being tested?
- C-MAC Macintosh blade Video Laryngoscope, DİRECT Laryngoscopy and D blade CMac videolaryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists (ASA) I to III,
- Patients requiring one-lung ventilation via DLT intubation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the D Blade and Mac Blade C-MAC Video Laryngoscope for Double-Lumen Endotracheal Intubation in Patients With Predicted Normal Airways
. 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.
Read the 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.
- Conditions
- Device Performance
- Being tested
- C-MAC Macintosh blade Video Laryngoscope, DİRECT Laryngoscopy, D blade CMac videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC Macintosh blade Video LaryngoscopeDevice
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 LaryngoscopyDevice
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 videolaryngoscopyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: C-MAC Macintosh blade Video Laryngoscope; Device: D blade CMac videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 10 minutes after intubation from recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jun 2022
- Primary completion1 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device PerformanceStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERAY AKGUL ERDIL, Inonu University
- Investigators
- Yeliz tunc ozer, doctor, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284251
- Sponsor's protocol ID
- INU-AR-FAE-01
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the D Blade and Mac Blade C-MAC Video Laryngoscope for Double-Lumen Endotracheal Intubation in Patients With Predicted Normal Airways
- ClinicalTrials.gov ID
- NCT07284251
- Acronym / sponsor ID
- INU-AR-FAE-01
- Conditions
- Device Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
. 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D blade | Active comparator | Device: C-MAC Macintosh blade Video Laryngoscope, Device: DİRECT LaryngoscopyDLT (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 M | Active comparator | Device: DİRECT Laryngoscopy, Device: D blade CMac videolaryngoscopyonce the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method |
| Group DL (Direct laryngoscopy macintosch blade, conventional . placebo) | Placebo comparator | Device: C-MAC Macintosh blade Video Laryngoscope, Device: D blade CMac videolaryngoscopyonce the bronchial cuff had passed through the vocal cords, the double-lumen tube was inserted using the conventional method |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with American Society of Anesthesiologists (ASA) I to III,
- Patients requiring one-lung ventilation via DLT intubation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-MAC Macintosh blade Video Laryngoscopevideolaryngoscopes 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. | Device | Group D blade, Group DL (Direct laryngoscopy macintosch blade, conventional . placebo) |
| DİRECT LaryngoscopyIn patients without predicted difficult airways undergoing thoracic surgery, direct laryngoscopy with a Mac blade remains the recommended technique for DLT placement | Device | Group D blade, Group M |
| D blade CMac videolaryngoscopyvideolaryngoscopes have been increasingly used in thoracic surgery, particularly in patients with difficult airways, as they enhance visualization of laryngeal structures and facilitate lung separation | Device | Group DL (Direct laryngoscopy macintosch blade, conventional . placebo), Group M |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeliz tunc ozer, doctor principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC Macintosh blade Video Laryngoscope, DİRECT Laryngoscopy and D blade CMac videolaryngoscopy in people with Device Performance, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation time (time frame: up to 10 minutes after intubation from recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.