Transcutaneous Laryngeal Ultrasound as an Alternative to Direct Flexible Laryngoscopy in Assessment of Vocal Cords

NCT ID: NCT06161467

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-01

Brief Summary

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To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy

Detailed Description

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Thyroid and parathyroid surgery are the most common procedures in endocrine surgery worldwide. They are mainly associated with two major complications: recurrent laryngeal nerve (RLN) palsy and hypoparathyroidism, The preservation of recurrent laryngeal nerve (RLN) is an essential part of thyroid surgery {1}. The various methods to test the normal functionality of vocal cords (VCs) include direct visualisation under the fiber bronchoscope, indirect laryngoscopy, laryngeal muscles electromyography, computed tomography (CT), and magnetic resonance imaging (MRI). We aimed to assess the usefulness of ultrasound (USG) in the examination of VC morphology and movement.

Recurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland.

Otolaryngology and Head and Neck Surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative DFL \[6\].

Laryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. As it can demonstrate a paralysis of the recurrent laryngeal nerve,. Yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. That is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. Availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and ICU patient \[4\] .

However, the experience is limited and the reliability of the TLUS in thyroid and parathyroid surgery is still being debated

Conditions

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Ultrasound Therapy; Complications

Keywords

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Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Ultrasound devices

Safe , no radiation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for thyroid surgery
* Patients underwent thyroid surgery

Exclusion Criteria

• Patients with vocal cord paralysis because of any cause other than thyroid surgery complications
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Walaa Mohamed Ali sayd

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Farouk, Professor

Role: PRINCIPAL_INVESTIGATOR

Supervisor

Central Contacts

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Wala Sayed, Student

Role: CONTACT

Phone: 01095876627

Email: [email protected]

Hasan Megaly, Professor

Role: CONTACT

Phone: 01006209584

Email: [email protected]

References

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American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer; Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009 Nov;19(11):1167-214. doi: 10.1089/thy.2009.0110.

Reference Type BACKGROUND
PMID: 19860577 (View on PubMed)

Holtel MR. Emerging technology in head and neck ultrasonography. Otolaryngol Clin North Am. 2010 Dec;43(6):1267-74, vii. doi: 10.1016/j.otc.2010.08.003.

Reference Type BACKGROUND
PMID: 21044741 (View on PubMed)

Other Identifiers

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vocal cords in US

Identifier Type: -

Identifier Source: org_study_id