Neurogenic DysphagiaFEES-RegistryNCT03037762
Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry
An observational study of Neurogenic Dysphagia and Flexible Endoscopic Evaluation of Swallowing, run by University Hospital Muenster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Dysphagia, Flexible Endoscopic Evaluation of Swallowing
- What is being tested?
- Flexible Endoscopic Evaluation of Swallowing
- Type of treatment
- Surgery or procedure
- How many people
- 2,401 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Oct 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected neurogenic dysphagia
Who may be able to join
- suspected neurogenic dysphagia
- Patients being scheduled for a FEES
- written informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Flexible Endoscopic Evaluation of Swallowing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Endoscopic Evaluation of SwallowingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: during the procedure
FEES-related side effects - 4. Nose bleed
Number of patients with nose bleed during the procedure
Measured: during the procedure
FEES-related side effects - 5. Laryngospasm
Number of patients with laryngospasm during the procedure
Measured: 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)
Measured: 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
Measured: during the procedure
Secondary outcomes (1)
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).
Measured: immediately prior and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startOct 2014
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,401 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Dziewas, MD, Principal investigator, University Hospital Muenster, Department of Neurology, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037762
- Sponsor's protocol ID
- 01072014
- Acronym
- FEES-Registry
- Status last verified
- Nov 2019
- First submitted
- 12 Jan 2017
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33324882
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry
- ClinicalTrials.gov ID
- NCT03037762
- Acronym / sponsor ID
- FEES-Registry / 01072014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,401 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected neurogenic dysphagia
Key inclusion criteria (3 listed)
- suspected neurogenic dysphagia
- Patients being scheduled for a FEES
- written informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible Endoscopic Evaluation of Swallowing | Procedure or surgery | – |
Primary outcome
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.
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.
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.
FEES-related side effects - 4. Nose bleed
Time frame: during the procedure
Number of patients with nose bleed during the procedure
FEES-related side effects - 5. Laryngospasm
Time frame: during the procedure
Number of patients with laryngospasm during the procedure
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)
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
1 secondary outcome
Changes of dietary status after FEES
Time frame: immediately prior and immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Derived from this study: PubMed 33324882Dziewas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Dziewas, MD principal investigator
University Hospital Muenster, Department of Neurology, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Dysphagia and Flexible Endoscopic Evaluation of Swallowing, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEES-related side effects - 1. systolic blood pressure increase (time frame: during the procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.