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

NCT03037762 | Completed

• 1 other identifier: 01072014
• Study Type: observational
• Target: 2,401
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Dysphagia; Flexible Endoscopic Evaluation of Swallowing

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Changes of dietary status after FEES

  immediately prior and immediately after the procedure

Interventions

Flexible Endoscopic Evaluation of Swallowing PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected neurogenic dysphagia

You may qualify if:

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

You may not qualify if:

• \- none

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital

Münster, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 33324882 DERIVED

Study Officials

• Rainer Dziewas, MD

  University Hospital Muenster, Department of Neurology, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 31, 2017
• Study Start: October 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)