DysphagiaNCT03753841
FEES to Determine Neurological Intensive Care Patients' Oral Diet
A study testing Adjustment of oral diet in people with Dysphagia and Aspiration Pneumonia, run by University of Giessen at 1 site in Germany.
Trial summary
Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysphagia, Aspiration Pneumonia, Deglutition Disorders
- What is being tested?
- Adjustment of oral diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2014to 16 Sep 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Treatment on neurological ICU
- Clinical suspicion of Dysphagia
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet
Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.
Read the detailed description
Dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. It is prevalent in critically ill patients, especially those who need mechanical ventilation. The investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU. All patients treated on the investigators neurological ICU will be eligible for this study.
The investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.
- Conditions
- Dysphagia, Aspiration Pneumonia, Deglutition Disorders, Intensive Care Neurological Disorder
- Being tested
- Adjustment of oral diet
- Keywords
- Dysphagia, Aspiration, Management of Dysphagia, Deglutition Disorders, Deglutition, FEES, Intensive Care Neurological Disorder
- Medical subject headings
- Deglutition Disorders, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustment of oral dietOther
Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)
| Study group | Role | What they receive |
|---|---|---|
| Adjustment of oral diet | Active comparator | Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet. Receives: Other: Adjustment of oral diet |
| No adjustment of oral diet | No intervention | Patients who have the adequat diet based on FEES findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia Rate
self-explanatory
Measured: Up to 130 days
Mortality
self-explanatory
Measured: Up to 130 days
Secondary outcomes (2)
Length of stay in hospital
self-explanatory
Measured: Up to 130 days
Intubation/Tracheotomy
Rate of Intubation/Tracheotomy
Measured: Up to 130 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start14 Jan 2014
- Primary completion3 Sep 2016
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Braun, University of Giessen
- Investigators
- Tobias Braun, M.D., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753841
- Sponsor's protocol ID
- GI 208/16-1
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors declare that the data supporting the findings of this study will be available within the published article(s). The data that support the findings of this study will not be publically available due to local medical data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet
- ClinicalTrials.gov ID
- NCT03753841
- Acronym / sponsor ID
- GI 208/16-1
- Conditions
- Dysphagia, Aspiration Pneumonia, Deglutition Disorders, Intensive Care Neurological Disorder
- Keywords
- Dysphagia, Aspiration, Management of Dysphagia, Deglutition Disorders, Deglutition, FEES, Intensive Care Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 3 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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.
Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.
Detailed description
Dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. It is prevalent in critically ill patients, especially those who need mechanical ventilation. The investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU. All patients treated on the investigators neurological ICU will be eligible for this study.
The investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjustment of oral diet | Active comparator | Other: Adjustment of oral dietPatients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet. |
| No adjustment of oral diet | No intervention | –Patients who have the adequat diet based on FEES findings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Treatment on neurological ICU
- Clinical suspicion of Dysphagia
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 |
|---|---|---|
| Adjustment of oral dietAdjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES) | Other | Adjustment of oral diet |
Primary outcome
Pneumonia Rate
Time frame: Up to 130 days
self-explanatory
Mortality
Time frame: Up to 130 days
self-explanatory
2 secondary outcomes
Length of stay in hospital
Time frame: Up to 130 days
Intubation/Tracheotomy
Time frame: Up to 130 days
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 27 Nov 2018.
- Individual participant dataSharing planned: No. The authors declare that the data supporting the findings of this study will be available within the published article(s). The data that support the findings of this study will not be publically available due to local medical data protection policies.
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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.
Tobias Braun, M.D. principal investigator
University of Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustment of oral diet in people with Dysphagia and Aspiration Pneumonia, run by University of Giessen 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 2 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 27 Nov 2018. 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?
Pneumonia Rate (time frame: Up to 130 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2018.