FEES to Determine Neurological Intensive Care Patients' Oral Diet

Study Overview
=================
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.

Official Title
-----------------
Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet

Conditions
-----------------
Dysphagia, Aspiration Pneumonia, Deglutition Disorders, Intensive Care Neurological Disorder

Intervention / Treatment
-----------------
* Other: Adjustment of oral diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment on neurological ICU Clinical suspicion of Dysphagia Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adjustment of oral diet<br>Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet. | Other: Adjustment of oral diet<br>* Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)<br>|
| No Intervention: No adjustment of oral diet<br>Patients who have the adequat diet based on FEES findings. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia Rate | self-explanatory | Up to 130 days | 
| Mortality | self-explanatory | Up to 130 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | self-explanatory | Up to 130 days | 
| Intubation/Tracheotomy | Rate of Intubation/Tracheotomy | Up to 130 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysphagia, Aspiration, Management of Dysphagia, Deglutition Disorders, Deglutition, FEES, Intensive Care Neurological Disorder