Clinical trial NCT03037762: Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry
Official title: Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Dysphagia
Flexible Endoscopic Evaluation of Swallowing
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 2401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected neurogenic dysphagia

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

- none

Primary outcomes:
measure: FEES-related side effects - 1. systolic blood pressure increase
timeFrame: during the procedure
measure: FEES-related side effects - 2. Oxygen saturation decline
timeFrame: during the procedure
measure: FEES-related side effects - 3. Heart rate decrease
timeFrame: during the procedure
measure: FEES-related side effects - 4. Nose bleed
timeFrame: during the procedure
measure: FEES-related side effects - 5. Laryngospasm
timeFrame: during the procedure
measure: FEES-related side effects - 6. Decreased level of consciousness
timeFrame: during the procedure
measure: Patients subjective FEES-related discomfort
timeFrame: during the procedure
Secondary outcomes:
measure: Changes of dietary status after FEES
timeFrame: immediately prior and immediately after the procedure
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital
Study officials:
affiliation: University Hospital Muenster, Department of Neurology, Germany
name: Rainer Dziewas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.