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

Completed

• Conditions: Neurogenic Dysphagia; Flexible Endoscopic Evaluation of Swallowing

• Registration Number: NCT03037762
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2401

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEES-related side effects - 6. Decreased level of consciousness	during the procedure	Number of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale)
FEES-related side effects - 2. Oxygen saturation decline	during the procedure	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.
FEES-related side effects - 1. systolic blood pressure increase	during the procedure	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.
FEES-related side effects - 3. Heart rate decrease	during the procedure	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.
FEES-related side effects - 5. Laryngospasm	during the procedure	Number of patients with laryngospasm during the procedure
FEES-related side effects - 4. Nose bleed	during the procedure	Number of patients with nose bleed during the procedure
Patients subjective FEES-related discomfort	during the procedure	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

Secondary Outcome Measures

Name	Time	Method
Changes of dietary status after FEES	immediately prior and immediately after the procedure	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).

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Muenster, Germany