Ultrasound for Throat Issues

Overseen By Sara Albert, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Age under 18, Open neck wound

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the usefulness of ultrasound (also known as ultrasound imaging or sonography) during certain throat-related medical procedures. The focus is on assisting individuals with swallowing difficulties, voice problems, and persistent neurogenic cough by using ultrasound to guide treatments such as nerve blocks and injections. Adults advised to undergo these procedures or diagnosed with vocal cord issues like paralysis or atrophy might be suitable candidates for this study. The trial aims to improve the accuracy and effectiveness of these treatments through real-time imaging. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment precision and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ultrasound is safe for laryngology interventions?

Research has shown that ultrasound is generally safe for throat issues. Studies have found it can diagnose vocal cord problems without surgery. Being non-invasive, it doesn't involve entering the body or cutting the skin, reducing the risk of complications.

For vocal cord problems, ultrasound offers a clear view of vocal cord movement. It is a simple and effective method. Although rare reports exist of vocal cord paralysis after related procedures, such complications are uncommon.

When addressing swallowing problems, known as dysphagia, ultrasound is considered safe. It can be repeated as needed and helps assess swallowing ability, which is especially beneficial for stroke patients.

For cough issues, research indicates that ultrasound-guided treatments are safe and help reduce symptoms. It has minimal side effects, making it a promising option for those with chronic cough.

Ultrasound also checks muscle tension in the throat for voice problems, known as dysphonia. It is reliable and safe, providing information on muscle movement during speech.

Overall, ultrasound is well-tolerated for these throat-related issues, with a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound for throat issues because it offers a non-invasive way to assist in diagnosing and treating conditions like vocal cord paralysis, dysphagia, and neurogenic cough. Unlike traditional methods that might require surgery or more invasive procedures, ultrasound can provide real-time imaging to guide treatments like injection laryngoplasty or nerve blocks with precision. This means potentially quicker recovery times and less discomfort for patients. Additionally, ultrasound helps in mapping normal anatomy and variations, which could lead to more personalized and effective treatments.

What evidence suggests that ultrasound is effective for throat issues?

Research shows that ultrasound is a promising tool for diagnosing and managing various throat issues. This trial will explore its effectiveness for specific conditions through different treatment arms. For vocal cord problems, such as in the "Vocal Cord Paralysis" and "Vocal Cord Atrophy" arms, ultrasound accurately detects conditions like vocal cord paralysis and weakness. It provides real-time images safely and non-invasively. In the "Dysphagia" arm, ultrasound reliably identifies and assesses swallowing difficulties. For the "Cough" arm, studies indicate that ultrasound-guided procedures can significantly reduce cough frequency and severity. Lastly, in the "Dysphonia" arm, ultrasound evaluates muscle tension and movement, offering a dependable way to assess and manage voice disorders. Overall, ultrasound proves to be a valuable, low-risk tool for diagnosing and treating various throat issues in this trial. ^{6 7 8 9 10}

Who Is on the Research Team?

Anaïs Rameau, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Adults with voice and swallowing issues like vocal cord paralysis, weakness, atrophy, hoarseness, coughing, or difficulty swallowing may join. Specific details on who can't participate are not provided.

Inclusion Criteria

I am over 18 and advised to have a nerve block for my cough.

I am over 18 and getting checked for voice issues.

I am over 18 and do not have a cough.

Exclusion Criteria

I have an open wound on my neck, including a tracheostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound-guided procedures such as superior laryngeal nerve block, injection laryngoplasty, and evaluations for swallowing and voice

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in volume of injectate and patient comfort measures

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound

Trial Overview The trial is testing the use of ultrasound in routine office procedures for patients with laryngeal conditions. It will evaluate how helpful and practical ultrasound is during nerve blocks, injection treatments into the vocal cords, and voice/swallow assessments.

How Is the Trial Designed?

Group I: Vocal Cord Paresis Experimental Treatment 1 Intervention

Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study.

Group II: Vocal Cord Paralysis Experimental Treatment 1 Intervention

Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study.

Group III: Vocal Cord Atrophy Experimental Treatment 1 Intervention

Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study.

Group IV: Dysphonia Experimental Treatment 1 Intervention

Adult patients referred to the Sean Parker Institute for the Voice for voice assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of voice complaints, and prior evaluation and treatments. Additionally, patients diagnosed with muscle tension dysphonia will be evaluated by ultrasound for the presence, size, and function of their suprahyoid musculature.

Group V: Dysphagia Experimental Treatment 1 Intervention

Adult patients referred to the Sean Parker Institute for the Voice for swallowing assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of swallowing complaints, and prior evaluation and treatments. Adult patients without swallowing complaints will also be recruited to define normal anatomy and variation.

Group VI: Cough Experimental Treatment 1 Intervention

Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have neurogenic cough for which superior laryngeal nerve block is recommended will undergo this procedure under ultrasound guidance. Patients without neurogenic cough will also be recruited for ultrasound assessment to establish landmarks and normal variation.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Laryngeal ultrasonography is a promising imaging tool that can aid in diagnosing and managing laryngeal conditions, especially in healthcare settings without immediate ENT services, as demonstrated through cases confirmed by CT and endoscopy.

This imaging technique can enhance safety by guiding procedures like tracheostomy and predicting complications such as postextubation stridor, making it particularly valuable during the SARS-CoV-2 pandemic to minimize aerosol-generating procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonography of the larynx: Novel use during the SARS-CoV-2 pandemic (Review). Cergan, R., Dumitru, M., Vrinceanu, D., et al.[2021]

Ultrasound imaging of the larynx in infants and children offers a novel approach to visualize normal anatomy and detect pathological conditions.

This method is particularly useful for assessing functional disorders and space-occupying lesions, although it has its own advantages and drawbacks that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal ultrasonography in infants and children: a new way of investigating. Normal and pathological findings. Garel, C., Contencin, P., Polonovski, JM., et al.[2019]

The increasing complexity of diagnostic ultrasound devices necessitates a focus on multiple safety aspects, including electrical safety, ultrasound safety, and functional safety, to ensure effective and safe use.

Future improvements in ultrasound safety will require not only better equipment but also enhanced training for examiners to ensure they can properly operate the devices and accurately interpret the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Technical safety in ultrasound diagnosis]. Zweifel, HJ.[2006]

This case highlights the successful use of oral administration of the ultrasound contrast agent SonoVue for diagnosing a pharyngoesophageal tumor in a patient with a cervical mass, which is a novel application not widely documented in medical literature.

The diagnosis was further validated through barium swallow imaging and an endoscopy-guided biopsy, demonstrating the efficacy of SonoVue in enhancing sonographic examination for better diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound contrast agent delivered per os first diagnoses pharyngoesophageal tumour. Antypa, E., Cokkinos, DD., Kalogeropoulos, I., et al.[2019]

In a large retrospective analysis involving over 78,000 doses of ultrasound contrast agents (Definity and Optison), only 0.01% of patients experienced severe adverse reactions, indicating a strong safety profile for these agents.

The study found that severe reactions were primarily in outpatients, with no serious events reported in critically ill patients, suggesting that ultrasound contrast agents are safe for use in a variety of clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses. Wei, K., Mulvagh, SL., Carson, L., et al.[2022]

Patients who received bedside ultrasound (US) reported significantly higher satisfaction scores in overall emergency department care, diagnostic testing, and their perception of the emergency physician compared to those who did not receive US, based on a study of 70 patients over 10 months.

The use of bedside US not only expedited care and diagnosis but also enhanced the patient-physician relationship, highlighting its importance in improving patient satisfaction in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside ultrasound maximizes patient satisfaction. Howard, ZD., Noble, VE., Marill, KA., et al.[2022]

Therapeutic ultrasound has been shown to significantly reduce pain intensity in patients with neck pain compared to sham or no treatment, based on a review of 12 randomized controlled trials involving 705 patients.

The safety profile of therapeutic ultrasound is favorable, as no adverse events were reported; however, its effectiveness when combined with other treatments for improving disability or quality of life remains unclear due to high variability in study results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Therapeutic Ultrasound for Neck Pain: A Systematic Review and Meta-Analysis. Qing, W., Shi, X., Zhang, Q., et al.[2021]

Otolaryngologists can effectively use ultrasound to diagnose neck masses and lesions, enhancing their ability to perform procedures in the head and neck area.

Recent advancements in ultrasound technology, including better resolution and portability, make it a practical tool for otolaryngologists, allowing them to integrate it into their clinical practices for improved patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and neck ultrasound: why now? Sniezek, JC.[2016]

This study introduces a novel approach to using diagnostic ultrasound for examining the larynx in children, utilizing a computed sonography system that allows for detailed visualization of key laryngeal structures.

The high frame rate of the ultrasound system (around 25 Hz) enables effective observation of dynamic processes in the larynx, making it possible to assess both anatomical and functional aspects of the laryngeal structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sonography of the larynx in childhood: new perspectives due to the use of computerized sonography. 1: Anatomy and method]. Grunert, D., Schöning, M., Stier, B.[2006]

A new ultrasound method was developed to objectively evaluate airway obstruction caused by tonsillar hypertrophy in children, involving 102 patients aged 2-12 years.

The study found that an intertonsillar distance to tongue base length ratio (ITD/TLTB) of 0.3 or less indicates obstructive tonsillar hypertrophy, with high sensitivity (96.5%) and specificity (95.6%), aiding in clinical decisions regarding tonsillectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Assessment Method With Ultrasound for Obstructive Tonsillar Hypertrophy in Children. Sağtaş, E., Mengi, E., Kara, CO., et al.[2021]

Ultrasound is a safe, non-invasive, and cost-effective imaging technique that provides high-resolution images, making it particularly effective for examining superficial structures in the head and neck.

When combined with tissue biopsy methods like fine needle aspiration cytology (FNAC), ultrasound becomes a highly specific diagnostic tool for conditions such as salivary gland disease and cervical lymphadenopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the use of ultrasound imaging in oral and maxillofacial surgery. Oeppen, RS., Gibson, D., Brennan, PA.[2022]

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

A survey of 105 members of the Italian National Society for Ultrasound revealed that while most physicians understand the bio-effects of ultrasound, only 50-60% correctly defined key safety terms like thermal index and mechanical index.

The results indicate a significant gap in knowledge regarding ultrasound safety, particularly concerning the mechanical index and its potential risks, highlighting the need for improved education and awareness among ultrasound practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of the bio-effects of ultrasound among physicians performing clinical ultrasonography: Results of a survey conducted by the Italian Society for Ultrasound in Medicine and Biology (SIUMB). Piscaglia, F., Tewelde, AG., Righini, R., et al.[2021]

Ultrasound contrast agents are generally safe for clinical use, with serious adverse reactions being rare and most adverse events being minor and self-resolving, such as headache and nausea.

The Contrast Media Safety Committee found that while intolerance to some components can occur, generalized allergy-like reactions are infrequent, emphasizing the overall well-tolerated nature of these agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents. Jakobsen, JA., Oyen, R., Thomsen, HS., et al.[2020]

Ultrasound techniques have been developed to assist in the rehabilitation of speech for individuals with severe hearing impairments and speech difficulties, providing clear visualization of tongue movements.

These techniques have shown promise in improving speech production, but further research is necessary to fully evaluate their effectiveness in speech rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound in speech therapy with adolescents and adults. Bernhardt, B., Gick, B., Bacsfalvi, P., et al.[2019]

Citations

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Long-term management of idiopathic cough with ... ... cough without complications. Conclusively, ultrasound-guided PRF of the phrenic nerve is safe and effective in managing idiopathic cough.

2. rapm.bmj.com rapm.bmj.com/content/48/Suppl_1/A264.1

36011 Ultrasound-guided superior laryngeal nerve block ... Results Cough severity index score of patient decreased from 40 to 20, with 70% decrease in the frequency of symptom. However, patient also noted a transient ...

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.829811/full

Ultrasound-Guided Block of the Internal Branch ... The primary outcome measures were the incidence and severity of sore throat and cough assessed 0.5, 2, 6, and 24 h after tracheal extubation. The secondary ...

4. journals.lww.com journals.lww.com/10.1097/MD.0000000000045162

Chronic cough: A review and prospects Chronic cough (CC) is a common respiratory disorder, with prevalence rates ranging from 10% to 20%.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11877381/

Primary Cough Headache Responded to Ultrasound Guided ... Several studies on the efficacy of GON block for primary headaches have been conducted. US-guided nerve blocks appear to be relatively safe, efficient, and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40900321/

Efficacy and safety of superior laryngeal nerve block in ... SLN block is a promising and safe intervention for neurogenic cough, demonstrating significant symptom relief and minimal adverse effects.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468785523002100

Efficacy of ultrasound guided superior laryngeal nerve ... The data showed the SLNB group had a significantly lower incidence of moderate to severe cough and agitation (p < 0.05), and a longer sedation time (p < 0.05).

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01819-x

Effect of postoperative ultrasound-guided internal superior ... The use of US-guided iSLN block can be effectively and safely applied to relieve POST after intubation of DLTs on thoracic surgery.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6703134/

Superior laryngeal nerve block for neurogenic cough Our data support that hypothesis that SLN block is a comparable and safe alternative to treating neurogenic cough patients with promising ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04642352

Office-Based Superior Laryngeal Nerve Block for ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough.