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Completed

NCT Number: NCT03037762

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

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.

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Key information

Conditions

Neurogenic Dysphagia Flexible Endoscopic Evaluation of Swallowing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Münster, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Flexible Endoscopic Evaluation of Swallowing

Procedure

Primary outcomes

  1. FEES-related side effects - 1. systolic blood pressure increase

    Time frame: 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.

  2. FEES-related side effects - 2. Oxygen saturation decline

    Time frame: 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.

  3. FEES-related side effects - 3. Heart rate decrease

    Time frame: 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.

  4. FEES-related side effects - 4. Nose bleed

    Time frame: during the procedure

    Number of patients with nose bleed during the procedure

  5. FEES-related side effects - 5. Laryngospasm

    Time frame: during the procedure

    Number of patients with laryngospasm during the procedure

  6. FEES-related side effects - 6. Decreased level of consciousness

    Time frame: during the procedure

    Number of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale)

  7. Patients subjective FEES-related discomfort

    Time frame: 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 outcomes

  1. Changes of dietary status after FEES

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Acronym: FEES-Registry

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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