Back to resultsFEES to Determine Neurological Intensive Care Patients' Oral Diet
Primary Purpose
Dysphagia, Aspiration Pneumonia, Deglutition Disorders
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Adjustment of oral diet
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Dysphagia, Aspiration, Management of Dysphagia, Deglutition Disorders, Deglutition, FEES, Intensive Care Neurological Disorder
Eligibility Criteria
Inclusion Criteria:
- Treatment on neurological ICU
- Clinical suspicion of Dysphagia
Exclusion Criteria:
- none
Sites / Locations
- Universitätsklinikum Gießen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Adjustment of oral diet
No adjustment of oral diet
Arm Description
Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.
Patients who have the adequat diet based on FEES findings.
Outcomes
Primary Outcome Measures
Pneumonia Rate
self-explanatory
Mortality
self-explanatory
Secondary Outcome Measures
Length of stay in hospital
self-explanatory
Intubation/Tracheotomy
Rate of Intubation/Tracheotomy
Full Information
NCT ID
NCT03753841
First Posted
November 16, 2018
Last Updated
November 22, 2018
Sponsor
University of Giessen
1. Study Identification
Unique Protocol Identification Number
NCT03753841
Brief Title
FEES to Determine Neurological Intensive Care Patients' Oral Diet
Official Title
Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 14, 2014 (Actual)
Primary Completion Date
September 3, 2016 (Actual)
Study Completion Date
September 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Giessen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Aspiration Pneumonia, Deglutition Disorders, Intensive Care Neurological Disorder
Keywords
Dysphagia, Aspiration, Management of Dysphagia, Deglutition Disorders, Deglutition, FEES, Intensive Care Neurological Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adjustment of oral diet
Arm Type
Active Comparator
Arm Description
Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.
Arm Title
No adjustment of oral diet
Arm Type
No Intervention
Arm Description
Patients who have the adequat diet based on FEES findings.
Intervention Type
Other
Intervention Name(s)
Adjustment of oral diet
Intervention Description
Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)
Primary Outcome Measure Information:
Title
Pneumonia Rate
Description
self-explanatory
Time Frame
Up to 130 days
Title
Mortality
Description
self-explanatory
Time Frame
Up to 130 days
Secondary Outcome Measure Information:
Title
Length of stay in hospital
Description
self-explanatory
Time Frame
Up to 130 days
Title
Intubation/Tracheotomy
Description
Rate of Intubation/Tracheotomy
Time Frame
Up to 130 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treatment on neurological ICU
Clinical suspicion of Dysphagia
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Braun, M.D.
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Gießen
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
FEES to Determine Neurological Intensive Care Patients' Oral Diet
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