Swallowing Evaluation in VF Immobility

Evaluation of Swallowing in Patients With Vocal Folds Immobility

Vocal fold immobility (VFI) often results in significant problems with dysphonia, dysphagia, and decreased cough strength. As one element of the dysphagia potentially associated with vocal fold immobility,

aspiration may create significant morbidity for these patients. An estimated 38% to 53% of patients with

untreated VFI have swallowing difficulties with aspiration.

Vocal fold immobility has important implication on the laryngeal airway protection during respiration,

phonation and swallowing. It is the most common neurological laryngeal disorder.

The immobility may be caused by neck and thoracic surgery. which can impair the innervation of the pharynx,

upper esophageal sphincter (U.E.S) and proximal esophagus but may also be due to malignancy,trauma,

Intracranial causes,or may be idiopathic

Study Overview

• Status: Not yet recruiting
• Conditions: Swallowing Disorder
• Intervention / Treatment: Device: Videofluoroscopy

Detailed Description

Besides the voice alteration, the lesion that causes of vocal fold immobility should also affect the pharyngeal phase of swallowing.

It was suggested that dysphagia in patient with vocal fold immobility has multifactor causes ; including limited airway protection and decrease laryngopharyngeal sensation based on the finding of the flexible endoscopy.

Another study revealed that pharyngeal phase abnormalities such as delayed initiation of swallowing, reduced laryngeal elevation, and reduced upper esophageal sphincter (UES) opening were found in video fluoroscopic swallowing studies (VFSS).

Several studies on the swallowing difficulties of patient with vocal fold immobility has been performed and reported that nearly 56% of these patients immobility have swallowing dysfunction.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Mohamed Zakaria Ahmed Elbakry, Resident; Phone Number: 01101941217; Email: mohamedelbakry970@gmail.com
• Study Contact Backup: Name: Eman Sayed; Phone Number: 01004082014; Email: eshh2003@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Vocal fold immobility

Description

Inclusion Criteria:

1. Age:above 18.
2. Gender:both sexes will be included in the study.

Exclusion Criteria:

1. patients with structural abnormalities of oral cavity, pharynx or larynx.
2. previous vocal fold injection or voice therapy.
3. other causes of dysphagia: esophageal cancer or spasm , gastric cancer, cancer larynx,or radio therapy .
4. . Patients with history of heart burn , acid regurgitation ,
5. other neurological disease ,stroke, hypothyroidism or dyspnea.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with Vocal fold immobility	Device: Videofluoroscopy; Swallowing assessment; Other Names: Nasofibroscopy
Control; Normal volunteer don't have dysphagia , neurological diseases , heart burn and acid regurgitation	Device: Videofluoroscopy; Swallowing assessment; Other Names: Nasofibroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To calculate the incidence of swallowing dysfunction in people with vocal fold immobility	Incidence of swallowing dysfunction in patients with vocal fold immobility will be determined by the Statistical Package for the Social Sciences (SPPS) after the diagnosis of swallowing dysfunction by fiberoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallow study (VFSS)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients	To detect which swallowing phase is causing the dysfunction by using Statistical Package for the Social Sciences (SPSS) program	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Assiut, Non-afiliated

Publications and helpful links

General Publications

• Heitmiller RF, Tseng E, Jones B. Prevalence of aspiration and laryngeal penetration in patients with unilateral vocal fold motion impairment. Dysphagia. 2000 Fall;15(4):184-7. doi: 10.1007/s004550000026.
• Ollivere B, Duce K, Rowlands G, Harrison P, O'Reilly BJ. Swallowing dysfunction in patients with unilateral vocal fold paralysis: aetiology and outcomes. J Laryngol Otol. 2006 Jan;120(1):38-41. doi: 10.1017/S0022215105003567. Epub 2005 Nov 25.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: Swallowing in VF immobility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No