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临床试验/NCT05542550
NCT05542550招募中不适用

Voice Rest and Injection Laryngoplasty: A Randomized Controlled Trial

University of Virginia2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Patient-perceived voice improvement

研究概览

简要总结

The purpose of this study is to evaluate the subjective, objective, and aerodynamic impact of voice rest following injection augmentation and compare the outcomes to patients with no post-procedure voice restrictions.

详细描述

Glottic insufficiency resulting from vocal fold immobility can have a significant negative impact on health and quality of life and is a major cause of dysphonia, dysphagia, and dyspnea. Vocal fold immobility can be unilateral or bilateral and complete or partial. Most commonly, it is caused by iatrogenic injury to the recurrent laryngeal nerve from thyroidectomy or anterior cervical disc fusion surgeries. Other causes include traumatic, idiopathic, malignant, and neurogenic. Variability exists in approach to surgical management. Degree of spontaneous recovery and thus timing of intervention varies based on severity and permanency of neurological injury. Initially described by Wilhelm Brünings in 1911, injection laryngoplasty, also known as injection augmentation, is a technique to improve glottic closure by injection of material to move the immobile vocal fold closer to midline. This improves voice quality and strain in patients with either unilateral or bilateral vocal fold hypomobility, immobility, atrophy, presbylarynx, vocal fold scar, and soft tissue loss. Improvement in glottic closure also results in better swallowing outcomes. Injection augmentation can be performed under general anesthesia in patients unable to tolerate the procedure while awake. Injection can be performed peroral, through a working channeled flexible laryngoscope, or a percutaneous approach. Percutaneous approaches can be further divided into transthyroid cartilage, transcricothyroid membrane, or transthyrohyoid membrane. All cases are performed under endoscopic guidance to ensure correct needle placement and adequate medialization of affected vocal fold. Congruent with the heterogeneity of injection laryngoplasty materials, approaches, and techniques, there also appears to be no data or expert consensus regarding voice rest following this procedure. This study aims to quantify the benefit of voice rest following vocal fold injection augmentation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Only patient is aware of treatment group

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old
  • Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, or Dr. Daniero for the following conditions:
  • Glottic insufficiency from atrophy, scar, or presbylarynx
  • Unilateral or bilateral vocal fold immobility
  • Unilateral or bilateral vocal fold hypomobility

排除标准

  • Prior history of head and neck radiation.
  • Active or recent (within 3 months) chemotherapy.
  • Age <18 years old
  • Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit
  • Presence of posterior glottic stenosis
  • Presence of acute laryngeal injury
  • Bedside inpatient injection augmentation
  • Vocal fold Injection with steroids or cidofovir

结局指标

主要结局

Patient-perceived voice improvement

时间窗: 2 weeks

Voice Handicap Index - 10. Scale range 0-40. Lower score designates lower voice impairment

次要结局

  • Phonation threshold pressure(2 weeks)
  • GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Daniero, MD

Principal Investigator

University of Virginia

研究点 (2)

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