Symptom Scoring for Predicting Vocal Cord Dysfunction (VCD)

Status Withdrawn

Clinical Trial Summary

Dr. Russell Traister, et al, describes a symptom scoring system based on retrospective chart review to help identify subjects with VCD. Dr. Traister assigned the following symptom scores: dysphonia (2), throat tightness (4), sensitivity to odors (3) and absence of wheezing (2). Patients scoring 4 or more points have a positive predictive value of 96% and a negative predictive value of 77% for VCD. This prospective study will look at a population of patients presenting to a large tertiary care referral center for symptoms of cough. Patients seen at the "Cough Clinic" are evaluated by a Pulmonologist and an Otolaryngologist. Each patient undergoes pulmonary function testing and VLS testing as part of the diagnostic workup. For this study the history would be expanded to include the 4 specific symptoms: dysphonia, throat tightness, sensitivity to odors and absence of wheezing. The symptoms will be scored and compared against the results of diagnostic testing to determine if these symptoms help predict those with vocal cord dysfunction (VCD).

Clinical Trial Description

Vocal cord dysfunction (VCD) refers to the abnormal adduction of the vocal cords during breathing resulting in extrathoracic airway obstruction. These patients often complain of wheezing, cough and shortness of breath. Symptoms of VCD mimic asthma often leading to misdiagnosis and exposure to unneeded medications. Speech therapy rather than medications is the mainstay of treatment for VCD. The gold standard diagnostic tool for detection of VCD is direct visualization of the vocal cords using flexible video assisted fiberoptic laryngoscopy (VLS). VCD is present if the cords constrict greater than 50% during the respiratory cycle. VLS is well tolerated however it is an invasive procedure and costly. Identifying patients who most likely have VCD for VLS testing would reduce health related expense and avoid unnecessary procedures. Dr. Russell Traister, et al, describes a symptom scoring system based on retrospective chart review to help identify subjects with VCD. Dr. Traister assigned the following symptom scores: dysphonia (2), throat tightness (4), sensitivity to odors (3) and absence of wheezing (2). Patients scoring 4 or more points have a positive predictive value of 96% and a negative predictive value of 77% for VCD. This prospective study will look at a population of patients presenting to a large tertiary care referral center for symptoms of cough. Currently patients seen at the "Cough Clinic" are evaluated by a pulmonologist and an Otolaryngologist during their visit. Each patient undergoes pulmonary function testing and VLS testing as part of the diagnostic workup. For this study the history would be expanded to include the 4 specific symptoms described above and scores tabulated and compared against the results of diagnostic testing. The findings of this study will help providers understand the characteristics of patients with VCD and use this information when deciding which patients should be referred for VLS testing. ;

Study Design

Related Conditions & MeSH terms

Vocal Cord Dysfunction

Clinical Trial Details

NCT number	NCT05114083
Study type	Observational
Source	Ohio State University
Contact
Status	Withdrawn
Phase
Start date	January 2017
Completion date	October 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.