C-MAC D-Blade vs Macintosh for Postoperative Vocal Cord Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2023-05-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Vocal Cord Mobility Recurrent Laryngeal Nerve Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Videolaryngoscope (C-MAC D-Blade)

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Direct Laryngoscope (Macintosh)

Intervention Type DEVICE

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.

Interventions

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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

Intervention Type DEVICE

Direct Laryngoscope (Macintosh)

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.

Intervention Type DEVICE

Other Intervention Names

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Direct Laryngoscope Macintosh Blade

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No