Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry

Study Overview
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Brief Summary
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Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of the efficacy and safety of swallowing, determination of appropriate feeding strategies and assessment of the efficacy of different swallowing manoeuvres. The literature furthermore indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at evaluating findings and side effects of FEES in a heterogeneous collective of patients with neurogenic dysphagia.

Official Title
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Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry

Conditions
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Neurogenic Dysphagia, Flexible Endoscopic Evaluation of Swallowing

Intervention / Treatment
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* Procedure: Flexible Endoscopic Evaluation of Swallowing


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: suspected neurogenic dysphagia Patients being scheduled for a FEES written informed consent Exclusion criteria: - none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Flexible Endoscopic Evaluation of Swallowing|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEES-related side effects - 1. systolic blood pressure increase | Systolic blood pressure will be measured directly prior, during and after the procedure. The initial value will be compared to the highest blood pressure value measured during/directly after the procedure. | during the procedure | 
| FEES-related side effects - 2. Oxygen saturation decline | Oxygen saturation will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure. | during the procedure | 
| FEES-related side effects - 3. Heart rate decrease | Heart rate will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure. | during the procedure | 
| FEES-related side effects - 4. Nose bleed | Number of patients with nose bleed during the procedure | during the procedure | 
| FEES-related side effects - 5. Laryngospasm | Number of patients with laryngospasm during the procedure | during the procedure | 
| FEES-related side effects - 6. Decreased level of consciousness | Number of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale) | during the procedure | 
| Patients subjective FEES-related discomfort | Number of patients with procedure related discomfort measured with a 4 point scale ranging from 1=no discomfort to 4=extremely painful sensation during the procedure | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of dietary status after FEES | Dietary status will be assessed directly prior to the procedure and immediately thereafter. Dietary status will be assessed with the Functional Oral Intake Scale (FOIS scale). | immediately prior and immediately after the procedure |