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临床试验/NCT07696429
NCT07696429已完成不适用

The Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux: A Randomized Double-Blind Placebo-Controlled Crossover Study

Mario Bilić1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form

研究概览

简要总结

The goal of this clinical trial is to learn if topical anesthesia (lidocaine spray) affects the phonation process during High-Speed Digital Imaging (HSDI) laryngoscopy in adults with laryngopharyngeal reflux (LPR). The main questions it aims to answer are:

Does topical anesthesia change phonation process parameters (such as mucosal wave amplitude, glottal closure pattern, phase symmetry, and periodicity) as assessed on the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form? Does topical anesthesia change the type of glottal insufficiency observed during phonation?

Researchers will compare HSDI recordings performed with topical anesthesia (lidocaine spray) to recordings performed with placebo (physiological saline) to see if topical anesthesia alters phonation process findings.

Participants will:

Undergo HSDI laryngoscopy recording on two consecutive days, once with topical anesthesia and once with placebo, in a randomized, double-blind order Have a detailed medical history taken and complete the Reflux Symptom Index (RSI) questionnaire Undergo fiberendoscopic examination for determination of the Reflux Finding Score (RFS) Return for a follow-up examination within three months, during which they will continue proton pump inhibitor therapy and hygienic-dietary measures

详细描述

Standard clinical practice for rigid transoral laryngoscopy, including High-Speed Digital Imaging (HSDI), includes the elective use of topical anesthesia of the oral cavity and oropharynx; however, clearly defined recommendations and indications for its use are lacking, and its potential effect on the phonation process has not been unequivocally established. Upon application to the oral cavity and oropharynx, anesthetic may drain into the larynx and desensitize the mucosa, potentially affecting sensorimotor aspects of laryngeal function. Existing studies on the effect of topical anesthesia on phonation during laryngoscopy are limited and report contradictory findings.

This prospective, randomized, double-blind, placebo-controlled crossover study assigned each participant a unique number via random number generator, determining the order of recording modalities (even numbers recorded first with topical anesthesia, odd numbers first without). Once assigned, the order could not be changed. Randomization and testing order were concealed from the examiner performing the HSDI recording.

Topical anesthesia (lidocaine spray, 100 mg/ml, 0.1 ml per actuation) or physiological saline (placebo) was applied by a junior physician, blinded to the substance used, to the base of the tongue, posterior pharyngeal wall, and soft palate (one actuation per site). HSDI recording was performed 5 minutes after application. Each participant underwent recording in both modalities on two consecutive days, a period considered sufficiently short to avoid confounding phonotraumatic, hormonal, or health-related changes.

HSDI recordings were performed by an experienced otorhinolaryngologist and phoniatrician (>5 years of experience) using a rigid 90° endoscope (Wolf 5562 HRES ENDOCAM with Wolf Auto LP 5132 Hlight light source, Richard Wolf GmbH, Knittlingen, Germany). Participants were seated upright with the tongue held protruded; the endoscope was passed along the midline of the tongue to visualize the full length of the vocal folds. Participants phonated the vowel /a/ dynamically and frequentially, and a 2-second HSDI recording was captured. Recordings were reviewed for quality (minimum 1,000 clear, focused, consecutive images of the full vocal fold length during the steady phonation phase); inadequate recordings were repeated. Fundamental frequency and phonation intensity were recorded via a microphone mounted on the endoscope with software processing. Maximum Phonation Time was determined from three stopwatch-timed measurements of sustained /a/ phonation, taken immediately before and after HSDI recording.

Each HSDI recording was independently assessed by two experienced otorhinolaryngologists/phoniatricians (>5 years of experience) using visual-perceptual analysis. Discrepancies in parameter scoring were resolved through joint re-analysis and discussion until consensus was reached before proceeding to the next recording. Assessment was standardized using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form and the European Laryngological Society (ELS) form for glottal closure pattern classification, along with a modified classification of glottal insufficiency. The Reflux Finding Score was re-determined from recordings according to the Belafsky et al. classification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants were unaware of whether they received topical anesthesia or placebo on a given day. The physician administering the substance (lidocaine spray or placebo) was blinded to its identity. The two independent assessors performing visual-perceptual analysis of the HSDI recordings were blinded to the treatment assignment for each recording.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed laryngopharyngeal reflux (LPR), defined as Reflux Symptom Index (RSI) >13 and Reflux Finding Score (RFS) >7 Age 18-45 years No prior HSDI recording Ability to tolerate HSDI examination without topical anesthesia

排除标准

  • Known allergy to lidocaine and/or other allergens Acute respiratory infection within the preceding month Current smokers or regular alcohol consumers Chronic rhinosinusitis Prior surgery and/or radiotherapy of the larynx, neck, or thyroid gland Inability to visualize the full length of the vocal folds during the 2-second HSDI recording for anatomical reasons

结局指标

主要结局

Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form

时间窗: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Parameters assessed by visual-perceptual analysis of HSDI recordings using the VALI form: glottal sufficiency pattern, mucosal wave amplitude, free edge amplitude, vertical level of the vocal folds, non-vibrating segment of the vocal fold, supraglottic structure activation, free edge contour, open-to-closed phase ratio of the glottal cycle, phase symmetry of the vocal folds, periodicity, and axis shift of the vocal folds. Each recording was independently scored by two blinded raters, with discrepancies resolved by consensus.

Change in Glottal Closure Pattern (European Laryngological Society Classification)

时间窗: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Glottal closure pattern during the initial phase of the glottal cycle, classified according to the European Laryngological Society (ELS) form (e.g., concave, convex, straight, complex), assessed by visual-perceptual analysis of HSDI recordings.

Change in Type of Glottal Insufficiency (European Laryngological Society Classification)

时间窗: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Type of glottal insufficiency during phonation, classified according to a modified European Laryngological Society (ELS) classification (e.g., complete glottal closure, incomplete closure in the cartilaginous part of the glottis), assessed by visual-perceptual analysis of HSDI recordings.

Change in Acoustic Voice Parameters (Fundamental Frequency and Phonation Intensity)

时间窗: Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Fundamental frequency (F0, Hz) and phonation intensity (dB) during phonation of the sustained vowel /a/, recorded via a microphone mounted on the endoscope with software processing.

Change in Maximum Phonation Time (MPT)

时间窗: Assessed immediately before and after each HSDI recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Maximum duration (seconds) of sustained, dynamically stationary phonation of the vowel /a/ following maximal inhalation, determined as the longest of three stopwatch-timed trials performed immediately before and after HSDI recording.

次要结局

未报告次要终点

研究者

发起方
Mario Bilić
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mario Bilić

Prof. Mario Bilić, MD, PhD Head of the Department of Head and Neck Tumors Department of Otorhinolaryngology and Head and Neck Surgery University Hospital Centre Zagreb, Zagreb, Croatia

Clinical Hospital Centre Zagreb

研究点 (1)

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