Swallowing Evaluation in VF Immobility

NCT05473169 | Unknown

• 1 other identifier: Swallowing in VF immobility
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Swallowing Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure the frequency of each swallowing phase which will be affected in vocal fold immobility patients

  Baseline

Study Arms (2)

Patients

Patients with Vocal fold immobility

Device: Videofluoroscopy

Control

Normal volunteer don't have dysphagia , neurological diseases , heart burn and acid regurgitation

Device: Videofluoroscopy

Interventions

Videofluoroscopy DEVICE

Swallowing assessment

Also known as: Nasofibroscopy

Control; Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Vocal fold immobility

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 11014880 BACKGROUND

• 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.

  PMID: 16359143 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Assiut

  Non-afiliated

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Zakaria Ahmed Elbakry, Resident

CONTACT

01101941217; mohamedelbakry970@gmail.com

Eman Sayed

CONTACT

01004082014; eshh2003@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: July 25, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07