Postoperative Vocal Cord MobilityNCT07277985
C-MAC D-Blade vs Macintosh for Postoperative Vocal Cord Evaluation
A study testing Videolaryngoscope (C-MAC D-Blade) and Direct Laryngoscope (Macintosh) in people with Postoperative Vocal Cord Mobility and Recurrent Laryngeal Nerve Injury, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study compares two different laryngoscopes-the C-MAC D-Blade videolaryngoscope and the Macintosh direct laryngoscope-for evaluating vocal cord mobility after thyroidectomy. Patients undergo standard anesthesia and intubation with one of the two devices. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Vocal Cord Mobility, Recurrent Laryngeal Nerve Injury
- What is being tested?
- Videolaryngoscope (C-MAC D-Blade) and Direct Laryngoscope (Macintosh)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2023to 26 May 2023
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 70 years.
- Height greater than 145 cm.
- Body mass index (BMI) between 20 and 35 kg/m².
- American Society of Anesthesiologists (ASA) physical status
- Scheduled for elective thyroid surgery under general anesthesia.
Who cannot join
- Prior neck surgery or radiotherapy
- Large thyroid mass causing severe anatomical distortion.
- Mouth opening less than 4 cm.
- Short neck less than 6 cm in length.
- Limited head and neck mobility
- Unexpected difficult intubation.
- Known history of recurrent laryngeal nerve injury
- Presence of any neurological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the C-MAC D-Blade Videolaryngoscope and the Macintosh Laryngoscope for Postoperative Vocal Cord Assessment After Thyroidectomy
This study compares two different laryngoscopes-the C-MAC D-Blade videolaryngoscope and the Macintosh direct laryngoscope-for evaluating vocal cord mobility after thyroidectomy. Patients undergo standard anesthesia and intubation with one of the two devices. After surgery, vocal cord function is assessed to identify early postoperative vocal cord impairment. The study aims to determine whether videolaryngoscopy provides a more reliable and less traumatic method for postoperative vocal cord evaluation compared with the traditional Macintosh laryngoscope.
Read the detailed description
This prospective randomized study evaluates two laryngoscopic techniques used during endotracheal intubation in patients undergoing thyroidectomy. The C-MAC D-Blade videolaryngoscope provides an angulated blade and video-assisted view of the glottis, while the Macintosh laryngoscope represents the traditional direct visualization method. Because postoperative vocal cord impairment is an important early indicator of potential recurrent laryngeal nerve injury after thyroidectomy, accurate assessment immediately after surgery is clinically valuable.
In this study, eligible patients were randomly assigned to intubation using either the C-MAC D-Blade videolaryngoscope or the Macintosh laryngoscope. All procedures were performed under standard anesthesia protocols by experienced anesthesiologists. After extubation and recovery, vocal cord mobility was evaluated using a standardized six-grade scoring system to assess postoperative vocal cord function.
The study compares intubation characteristics, glottic views, optimization maneuvers, hemodynamic responses, and postoperative vocal cord mobility between the two devices. The primary aim is to determine whether videolaryngoscopy offers a more reliable and less traumatic method for postoperative vocal cord evaluation. Secondary objectives include evaluating ease of intubation, maneuver requirements, and perioperative physiological responses. The findings may help guide device selection for airway management in thyroid surgery and improve early detection of recurrent laryngeal nerve dysfunction.
- Being tested
- Videolaryngoscope (C-MAC D-Blade), Direct Laryngoscope (Macintosh)
- Keywords
- Thyroidectomy, Macintosh Laryngoscope, Videolaryngoscope, Airway Management, Vocal Cord Mobility, Recurrent Laryngeal Nerve
- Medical subject headings
- Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videolaryngoscope (C-MAC D-Blade)Device
The C-MAC D-Blade videolaryngoscope was used to perform endotracheal intubation and to obtain a video-assisted view of the glottis. Its angulated blade design allows indirect visualization, providing improved glottic exposure during intubation and postoperative vocal cord mobility assessment
Direct Laryngoscope (Macintosh)Device
Also called Direct Laryngoscope, Macintosh Blade
The Macintosh direct laryngoscope was used for endotracheal intubation with conventional direct visualization of the glottis. This standard laryngoscopic technique was also used for postoperative assessment of vocal cord mobility.
| Study group | Role | What they receive |
|---|---|---|
| C-MAC D-Blade Videolaryngoscope | Experimental | Patients in this group were intubated using the C-MAC D-Blade videolaryngoscope to facilitate glottic visualization and to perform postoperative vocal cord mobility assessment. Receives: Device: Videolaryngoscope (C-MAC D-Blade) |
| Macintosh Laryngoscope | Active comparator | Patients in this group were intubated with the traditional Macintosh direct laryngoscope, which was also used for postoperative assessment of vocal cord mobility. Receives: Device: Direct Laryngoscope (Macintosh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Vocal Cord Mobility Score
Vocal cord mobility will be assessed using a standardized six-grade scoring system (I-VI) to detect postoperative vocal cord impairment after thyroidectomy.
Measured: Within 30 minutes after extubation
Secondary outcomes (2)
Glottic View (Cormack-Lehane Grade)
The view of the glottis during intubation will be assessed using the Cormack-Lehane grading system.
Measured: During intubation procedure
Need for Optimization Maneuvers
Whether external laryngeal maneuvers or additional attempts were required to facilitate intubation.
Measured: During intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start23 Jan 2023
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Vocal Cord MobilityStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the C-MAC D-Blade videolaryngoscope group or the Macintosh laryngoscope group. Both groups were followed and evaluated in parallel throughout the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Akbulut, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277985
- Sponsor's protocol ID
- 2022/115
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains identifiable clinical information and the study was not designed with external data distribution in mind
Publications
Chilkoti GT, Gupta A, Bhandari P, Mohta M. Techniques of detecting recurrent laryngeal nerve palsy in patients undergoing thyroid surgery: Pearls and pitfalls. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):199-205. doi: 10.4103/joacp.joacp_346_22. Epub 2024 Apr 8.
PubMed 38919442Sastre JA, Lopez T, Del Barrio ME. Airtraq(R) videolaryngoscope for assessing vocal cord mobility at the end of thyroidectomy. J Clin Anesth. 2017 May;38:3-4. doi: 10.1016/j.jclinane.2017.01.012. Epub 2017 Jan 12. No abstract available.
PubMed 28372672Priyanka AS, Nag K, Hemanth Kumar VR, Singh DR, Kumar S, Sivashanmugam T. Comparison of King Vision and Truview Laryngoscope for Postextubation Visualization of Vocal Cord Mobility in Patients Undergoing Thyroid and Major Neck Surgeries: A Randomized Clinical Trial. Anesth Essays Res. 2017 Jan-Mar;11(1):238-242. doi: 10.4103/0259-1162.200240.
PubMed 28298792Kundra P, Kumar V, Srinivasan K, Gopalakrishnan S, Krishnappa S. Laryngoscopic techniques to assess vocal cord mobility following thyroid surgery. ANZ J Surg. 2010 Nov;80(11):817-21. doi: 10.1111/j.1445-2197.2010.05441.x. Epub 2010 Aug 19.
PubMed 20969690Chilkoti GT, Bhandari P, Mohta M, Saxena AK, Kapoor R. Comparison of the Efficacy of Macintosh Laryngoscope Versus Airtraq Videolaryngoscope for Visualization of Laryngeal Structures at the End of Thyroidectomy: A Randomized Control Study. Indian J Otolaryngol Head Neck Surg. 2023 Dec;75(4):3191-3198. doi: 10.1007/s12070-023-03828-9. Epub 2023 Jun 15.
PubMed 37974697Gangappa RB, Kenchannavar MB, Chowdary PB, Patanki AM, Ishwar M. Total Thyroidectomy for Benign Thyroid Diseases: What is the Price to be Paid? J Clin Diagn Res. 2016 Jun;10(6):PC04-7. doi: 10.7860/JCDR/2016/18733.7991. Epub 2016 Jun 1.
PubMed 27504342AlOsaif ZA, Al Bisher HM, Elshnawie HA, Al-Hariri MT. The Impact of Thyroidectomy and Lobectomy on Patients' Health-Related Quality of Life, Eastern Region, Saudi Arabia. Clin Pract. 2024 Jun 29;14(4):1251-1263. doi: 10.3390/clinpract14040101.
PubMed 39051295
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the C-MAC D-Blade Videolaryngoscope and the Macintosh Laryngoscope for Postoperative Vocal Cord Assessment After Thyroidectomy
- ClinicalTrials.gov ID
- NCT07277985
- Acronym / sponsor ID
- 2022/115
- Keywords
- Thyroidectomy, Macintosh Laryngoscope, Videolaryngoscope, Airway Management, Vocal Cord Mobility, Recurrent Laryngeal Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 11 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.
This study compares two different laryngoscopes-the C-MAC D-Blade videolaryngoscope and the Macintosh direct laryngoscope-for evaluating vocal cord mobility after thyroidectomy. Patients undergo standard anesthesia and intubation with one of the two devices. After surgery, vocal cord function is assessed to identify early postoperative vocal cord impairment. The study aims to determine whether videolaryngoscopy provides a more reliable and less traumatic method for postoperative vocal cord evaluation compared with the traditional Macintosh laryngoscope.
Detailed description
This prospective randomized study evaluates two laryngoscopic techniques used during endotracheal intubation in patients undergoing thyroidectomy. The C-MAC D-Blade videolaryngoscope provides an angulated blade and video-assisted view of the glottis, while the Macintosh laryngoscope represents the traditional direct visualization method. Because postoperative vocal cord impairment is an important early indicator of potential recurrent laryngeal nerve injury after thyroidectomy, accurate assessment immediately after surgery is clinically valuable.
In this study, eligible patients were randomly assigned to intubation using either the C-MAC D-Blade videolaryngoscope or the Macintosh laryngoscope. All procedures were performed under standard anesthesia protocols by experienced anesthesiologists. After extubation and recovery, vocal cord mobility was evaluated using a standardized six-grade scoring system to assess postoperative vocal cord function.
The study compares intubation characteristics, glottic views, optimization maneuvers, hemodynamic responses, and postoperative vocal cord mobility between the two devices. The primary aim is to determine whether videolaryngoscopy offers a more reliable and less traumatic method for postoperative vocal cord evaluation. Secondary objectives include evaluating ease of intubation, maneuver requirements, and perioperative physiological responses. The findings may help guide device selection for airway management in thyroid surgery and improve early detection of recurrent laryngeal nerve dysfunction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the C-MAC D-Blade videolaryngoscope group or the Macintosh laryngoscope group. Both groups were followed and evaluated in parallel throughout the study.
| Arm | Type | Receives |
|---|---|---|
| C-MAC D-Blade Videolaryngoscope | Experimental | Device: Videolaryngoscope (C-MAC D-Blade)Patients in this group were intubated using the C-MAC D-Blade videolaryngoscope to facilitate glottic visualization and to perform postoperative vocal cord mobility assessment. |
| Macintosh Laryngoscope | Active comparator | Device: Direct Laryngoscope (Macintosh)Patients in this group were intubated with the traditional Macintosh direct laryngoscope, which was also used for postoperative assessment of vocal cord mobility. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 20 and 70 years.
- Height greater than 145 cm.
- Body mass index (BMI) between 20 and 35 kg/m².
- American Society of Anesthesiologists (ASA) physical status
- Scheduled for elective thyroid surgery under general anesthesia.
Key exclusion criteria (8 listed)
- Prior neck surgery or radiotherapy
- Large thyroid mass causing severe anatomical distortion.
- Mouth opening less than 4 cm.
- Short neck less than 6 cm in length.
- Limited head and neck mobility
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 |
|---|---|---|
| Videolaryngoscope (C-MAC D-Blade)The C-MAC D-Blade videolaryngoscope was used to perform endotracheal intubation and to obtain a video-assisted view of the glottis. Its angulated blade design allows indirect visualization, providing improved glottic exposure during intubation and postoperative vocal cord mobility assessment | Device | C-MAC D-Blade Videolaryngoscope |
| Direct Laryngoscope (Macintosh)Also: Direct Laryngoscope, Macintosh BladeThe Macintosh direct laryngoscope was used for endotracheal intubation with conventional direct visualization of the glottis. This standard laryngoscopic technique was also used for postoperative assessment of vocal cord mobility. | Device | Macintosh Laryngoscope |
Primary outcome
Postoperative Vocal Cord Mobility Score
Time frame: Within 30 minutes after extubation
Vocal cord mobility will be assessed using a standardized six-grade scoring system (I-VI) to detect postoperative vocal cord impairment after thyroidectomy.
2 secondary outcomes
Glottic View (Cormack-Lehane Grade)
Time frame: During intubation procedure
Need for Optimization Maneuvers
Time frame: During intubation procedure
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 12 Dec 2025.
- Results publication: PubMed 38919442Chilkoti GT, Gupta A, Bhandari P, Mohta M. Techniques of detecting recurrent laryngeal nerve palsy in patients undergoing thyroid surgery: Pearls and pitfalls. J Anaesthesiol Clin Pharmacol. 2024 Apr-Jun;40(2):199-205. doi: 10.4103/joacp.joacp_346_22. Epub 2024 Apr 8.
- Results publication: PubMed 28372672Sastre JA, Lopez T, Del Barrio ME. Airtraq(R) videolaryngoscope for assessing vocal cord mobility at the end of thyroidectomy. J Clin Anesth. 2017 May;38:3-4. doi: 10.1016/j.jclinane.2017.01.012. Epub 2017 Jan 12. No abstract available.
- Results publication: PubMed 28298792Priyanka AS, Nag K, Hemanth Kumar VR, Singh DR, Kumar S, Sivashanmugam T. Comparison of King Vision and Truview Laryngoscope for Postextubation Visualization of Vocal Cord Mobility in Patients Undergoing Thyroid and Major Neck Surgeries: A Randomized Clinical Trial. Anesth Essays Res. 2017 Jan-Mar;11(1):238-242. doi: 10.4103/0259-1162.200240.
- Results publication: PubMed 20969690Kundra P, Kumar V, Srinivasan K, Gopalakrishnan S, Krishnappa S. Laryngoscopic techniques to assess vocal cord mobility following thyroid surgery. ANZ J Surg. 2010 Nov;80(11):817-21. doi: 10.1111/j.1445-2197.2010.05441.x. Epub 2010 Aug 19.
- Results publication: PubMed 37974697Chilkoti GT, Bhandari P, Mohta M, Saxena AK, Kapoor R. Comparison of the Efficacy of Macintosh Laryngoscope Versus Airtraq Videolaryngoscope for Visualization of Laryngeal Structures at the End of Thyroidectomy: A Randomized Control Study. Indian J Otolaryngol Head Neck Surg. 2023 Dec;75(4):3191-3198. doi: 10.1007/s12070-023-03828-9. Epub 2023 Jun 15.
- Results publication: PubMed 27504342Gangappa RB, Kenchannavar MB, Chowdary PB, Patanki AM, Ishwar M. Total Thyroidectomy for Benign Thyroid Diseases: What is the Price to be Paid? J Clin Diagn Res. 2016 Jun;10(6):PC04-7. doi: 10.7860/JCDR/2016/18733.7991. Epub 2016 Jun 1.
- Results publication: PubMed 39051295AlOsaif ZA, Al Bisher HM, Elshnawie HA, Al-Hariri MT. The Impact of Thyroidectomy and Lobectomy on Patients' Health-Related Quality of Life, Eastern Region, Saudi Arabia. Clin Pract. 2024 Jun 29;14(4):1251-1263. doi: 10.3390/clinpract14040101.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains identifiable clinical information and the study was not designed with external data distribution in mind
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope (C-MAC D-Blade) and Direct Laryngoscope (Macintosh) in people with Postoperative Vocal Cord Mobility and Recurrent Laryngeal Nerve Injury, 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 5 inclusion and 8 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 12 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. 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?
Postoperative Vocal Cord Mobility Score (time frame: Within 30 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07277985, which also lists 7 linked publications.
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 12 Dec 2025.