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

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Dysphagia; Flexible Endoscopic Evaluation of Swallowing
• Intervention / Treatment: Procedure: Flexible Endoscopic Evaluation of Swallowing

• Study Type: Observational
• Enrollment (Actual): 2401

Contacts and Locations

Study Locations

• Germany
  • Muenster, Germany, 48149
    • University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected neurogenic dysphagia

Description

Inclusion criteria:

• suspected neurogenic dysphagia
• Patients being scheduled for a FEES
• written informed consent

Exclusion criteria:

- none

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Rainer Dziewas, MD, University Hospital Muenster, Department of Neurology, Germany

Publications and helpful links

General Publications

• Dziewas R, Auf dem Brinke M, Birkmann U, Brauer G, Busch K, Cerra F, Damm-Lunau R, Dunkel J, Fellgiebel A, Garms E, Glahn J, Hagen S, Held S, Helfer C, Hiller M, Horn-Schenk C, Kley C, Lange N, Lapa S, Ledl C, Lindner-Pfleghar B, Mertl-Rotzer M, Muller M, Neugebauer H, Ozsucu D, Ohms M, Perniss M, Pfeilschifter W, Plass T, Roth C, Roukens R, Schmidt-Wilcke T, Schumann B, Schwarze J, Schweikert K, Stege H, Theuerkauf D, Thomas RS, Vahle U, Voigt N, Weber H, Werner CJ, Wirth R, Wittich I, Woldag H, Warnecke T. Safety and clinical impact of FEES - results of the FEES-registry. Neurol Res Pract. 2019 Apr 26;1:16. doi: 10.1186/s42466-019-0021-5. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

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: 01072014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO