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

Neurogenic Dysphagia Clinical Trial

— FEES-Registry  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037762
• Other study ID #: 01072014
• Status: Completed
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: November 2019
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2401
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• suspected neurogenic dysphagia

• Patients being scheduled for a FEES

• written informed consent

Exclusion criteria:

• none

Related Conditions & MeSH terms

• Deglutition Disorders
• Flexible Endoscopic Evaluation of Swallowing
• Neurogenic Dysphagia

Intervention

Procedure:
• Flexible Endoscopic Evaluation of Swallowing

Locations

Country	Name	City	State
Germany	University Hospital	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	FEES-related side effects - 4. Nose bleed	Number of patients with nose bleed during the procedure	during the procedure
Primary	FEES-related side effects - 5. Laryngospasm	Number of patients with laryngospasm during the procedure	during the procedure
Primary	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
Primary	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	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