Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFujian Medical University

About this trial

This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-60 years old.

Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.

Disqualifiers

History of past head and neck surgeries.

Pronunciation system defect and disorder history.

History of vocal cord polyps or nodules.

History of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history.

Trial population

People with thyroid cancer who are planned to undergo traditional surgical treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Traditional thyroid surgery.

    Procedure/Surgery

    The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Normal Signal Group.1 intervention
Group B: Signal Decrease 10-50%.1 intervention
Group C: Signal Decrease 50-90%.1 intervention
Group D: Signal Absence Group.1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative electromyographic signals.

Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.

Time frame
During the surgery, record R1 and V1 signals when initially identifying the recurrent laryngeal nerve or vagus nerve. After the surgery, record R2 and V2 signals upon re-identification of the recurrent laryngeal nerve or vagus nerve.
2

Voice analysis data(SPL)

Recording data(SPL) of voice tests before and after the surgery, sound pressure level in dB(A)

Time frame
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
3

Voice analysis data(F0)

Recording data(F0) of voice tests before and after the surgery, F0 in Hz

Time frame
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
4

Voice analysis data(Jitter)

Recording data(Jitter) of voice tests before and after the surgery, Jitter in percentage

Time frame
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.

Secondary outcomes

1

RBH

Conducted by an otolaryngologist, the RBH assessment includes R (Roughness), B (Breathiness), and H (Hoarseness).

Time frame
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
2

VHI-30

Voice Handicap Index, including a scale with 30 items.The full, non-abbreviated title of the VHI-30 scale is the "Voice Handicap Index-30," and it is translated as the "Voice Disorder Severity Index." The scale ranges from a minimum score of 0 to a maximum of 120, with higher scores indicating poorer outcomes.

Time frame
Before the surgery, 2 weeks after the surgery, 2 months after the surgery, 4 months after the surgery, and 6 months after the surgery.
3

Neural Width

Recorded width of the recurrent laryngeal nerve in millimeters.

Time frame
During surgery.
4

Is there branching

Note if the recurrent laryngeal nerve branches.

Time frame
During surgery.

Other outcomes

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