Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Location status: Recruiting
NCT Number: NCT06254859
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.
Interested in participating?
Request InfoAll sexes
Observational
Fuzhou, Fujian, 350001, China
Location status: Recruiting
This research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. The study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. The primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. By establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. This includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. Through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient undergoes traditional thyroid surgery with concurrent intraoperative nerve monitoring technology.
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.
Recording intraoperative electromyographic signals, including vagus nerve V1 and V2 signals, recurrent laryngeal nerve R1 and R2 signals.
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.
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.
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.
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.
Recording data(Shimmer) of voice tests before and after the surgery, Shimmer 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.
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.
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: During surgery.
Recorded width of the recurrent laryngeal nerve in millimeters.
Time frame: During surgery.
Note if the recurrent laryngeal nerve branches.
Time frame: During surgery.
If there are branches in the recurrent laryngeal nerve, record the number of branches.
Contact information is provided by the study sponsor or research team.
Fujian Medical University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06730321
Adenocarcinoma, Adenocarcinoma, Papillary
Shanghai, China
View Trial DetailsNCT04462471
Adenocarcinoma, Adenocarcinoma, Papillary
Basking Ridge, New Jersey, United States
View Trial DetailsNCT06439745
Adenocarcinoma, Adenocarcinoma, Papillary
View Trial DetailsNCT04594720
Adenocarcinoma, Adenocarcinoma, Papillary
Kaohsiung City, Taiwan
View Trial Details