- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277985
C-MAC D-Blade vs Macintosh for Postoperative Vocal Cord Evaluation
Comparison of the C-MAC D-Blade Videolaryngoscope and the Macintosh Laryngoscope for Postoperative Vocal Cord Assessment After Thyroidectomy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44280
- Inonu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: C-MAC D-Blade Videolaryngoscope
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.
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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
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Active Comparator: Macintosh Laryngoscope
Patients in this group were intubated with the traditional Macintosh direct laryngoscope, which was also used for postoperative assessment of vocal cord mobility.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Vocal Cord Mobility Score
Time Frame: Within 30 minutes after extubation
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Vocal cord mobility will be assessed using a standardized six-grade scoring system (I-VI) to detect postoperative vocal cord impairment after thyroidectomy.
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Within 30 minutes after extubation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Glottic View (Cormack-Lehane Grade)
Time Frame: During intubation procedure
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The view of the glottis during intubation will be assessed using the Cormack-Lehane grading system.
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During intubation procedure
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Need for Optimization Maneuvers
Time Frame: During intubation procedure
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Whether external laryngeal maneuvers or additional attempts were required to facilitate intubation.
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During intubation procedure
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Sastre 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.
- Priyanka 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.
- Kundra 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.
- Chilkoti 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.
- Gangappa 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.
- AlOsaif 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.
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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