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

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ClinicalTrials.gov Identifier: NCT03037762
Recruitment Status : Unknown
Verified January 2017 by University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Neurogenic Dysphagia Flexible Endoscopic Evaluation of Swallowing Procedure: Flexible Endoscopic Evaluation of Swallowing

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry
Study Start Date : October 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected neurogenic dysphagia
Criteria

Inclusion criteria:

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

Exclusion criteria:

- none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037762


Contacts
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Contact: Rainer Dziewas, MD +49251834 ext 6816 dziewas@uni-muenster.de
Contact: Tobias Warnecke, MD tobias.warnecke@ukmuenster.de

Locations
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Germany
University Hospital Recruiting
Muenster, Germany, 48149
Contact: Rainer Dziewas, MD    +4925183 ext 46816    dziewas@uni-muenster.de   
Contact: Tobias Warnecke, MD    +4925183 ext 46816    tobias.warnecke@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Rainer Dziewas, MD University Hospital Muenster, Department of Neurology, Germany

Additional Information:

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT03037762     History of Changes
Other Study ID Numbers: 01072014
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No