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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03037762
Acronym
FEES-Registry
Enrollment
2401
Registered
2017-01-31
Start date
2014-10-31
Completion date
2017-10-31
Last updated
2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic Dysphagia, Flexible Endoscopic Evaluation of Swallowing

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.

Interventions

Sponsors

University Hospital Muenster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- none

Design outcomes

Primary

MeasureTime frameDescription
Patients subjective FEES-related discomfortduring the procedureNumber 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
FEES-related side effects - 1. systolic blood pressure increaseduring the procedureSystolic 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.
FEES-related side effects - 2. Oxygen saturation declineduring the procedureOxygen 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.
FEES-related side effects - 3. Heart rate decreaseduring the procedureHeart 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.
FEES-related side effects - 4. Nose bleedduring the procedureNumber of patients with nose bleed during the procedure
FEES-related side effects - 5. Laryngospasmduring the procedureNumber of patients with laryngospasm during the procedure
FEES-related side effects - 6. Decreased level of consciousnessduring the procedureNumber of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale)

Secondary

MeasureTime frameDescription
Changes of dietary status after FEESimmediately prior and immediately after the procedureDietary 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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026