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Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux

6 de julio de 2026 actualizado por: Mario Bilić

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

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

Descripción general del estudio

Estado

Terminado

Descripción detallada

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.

Participants underwent a follow-up examination within three months of study participation, during which the Reflux Finding Score (via fiberendoscopy) and Reflux Symptom Index (via questionnaire) were re-assessed while participants continued regular proton pump inhibitor therapy and hygienic-dietary measures; participants with persistent pathological findings were excluded from final analysis.

Statistical analysis included the Kolmogorov-Smirnov test for normality of distribution. Normally distributed variables were described using means and standard deviations; non-normally distributed variables were described using medians and ranges. Differences between recordings with and without topical anesthesia were tested using the paired t-test (parametric) or Wilcoxon signed-rank test (non-parametric), as appropriate. Spearman correlation and regression analysis were used to explore associations between anatomical structures and measured characteristics. A p-value <0.05 was considered statistically significant.

Tipo de estudio

Intervencionista

Inscripción (Actual)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Zagreb, Croacia, 10000
        • University Hospital Centre Zagreb (KBC Zagreb), Department of ORL Head and Neck Surgery

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Anesthesia-First Sequence (A→B)
Participants received topical anesthesia (lidocaine spray, 100 mg/ml) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received placebo (physiological saline), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization.
Lidocaine spray, 100 mg/ml, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment.
Otros nombres:
  • Aerosol de xilocaína
Physiological saline (0.9% NaCl) spray, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment, identical in application technique to the lidocaine intervention.
Otros nombres:
  • Normal saline spray; 0.9% NaCl spray
Comparador de placebos: Placebo-First Sequence (B→A)
Participants received placebo (physiological saline) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received topical anesthesia (lidocaine spray, 100 mg/ml), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization.
Lidocaine spray, 100 mg/ml, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment.
Otros nombres:
  • Aerosol de xilocaína
Physiological saline (0.9% NaCl) spray, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment, identical in application technique to the lidocaine intervention.
Otros nombres:
  • Normal saline spray; 0.9% NaCl spray

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form
Periodo de tiempo: 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.
Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Glottal Closure Pattern (European Laryngological Society Classification)
Periodo de tiempo: 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.
Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Type of Glottal Insufficiency (European Laryngological Society Classification)
Periodo de tiempo: 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.
Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Acoustic Voice Parameters (Fundamental Frequency and Phonation Intensity)
Periodo de tiempo: 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.
Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)
Change in Maximum Phonation Time (MPT)
Periodo de tiempo: 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.
Assessed immediately before and after each HSDI recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Mario Bilić, prof. dr. sc. dr. med., Department of ORL Head and Neck Surgery, University Hospital Centre Zagreb, Croatia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2019

Finalización primaria (Actual)

5 de enero de 2021

Finalización del estudio (Actual)

5 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2026

Publicado por primera vez (Actual)

10 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data are not made publicly available due to privacy and confidentiality restrictions related to patient health information. De-identified data underlying the results reported in this publication may be made available by the corresponding author upon reasonable request, subject to institutional and ethics committee approval.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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