NCT07277985

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 1, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

ThyroidectomyMacintosh LaryngoscopeVideolaryngoscopeAirway ManagementVocal Cord MobilityRecurrent Laryngeal Nerve

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 30 minutes after extubation

Secondary Outcomes (2)

  • Glottic View (Cormack-Lehane Grade)

    During intubation procedure

  • Need for Optimization Maneuvers

    During intubation procedure

Study Arms (2)

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.

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.

Device: Direct Laryngoscope (Macintosh)

Interventions

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

C-MAC D-Blade Videolaryngoscope

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.

Also known as: Direct Laryngoscope, Macintosh Blade
Macintosh Laryngoscope

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

MeSH Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Laryngeal Nerve InjuriesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve InjuriesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Randomization was performed by an anesthesiologist not involved in the study procedures, ensuring that the participant, care provider, and investigator remained masked to group assignment. The outcomes assessor was not masked.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 11, 2025

Study Start

January 23, 2023

Primary Completion

May 26, 2023

Study Completion

May 26, 2023

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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

Locations