FEES to Determine Neurological Intensive Care Patients' Oral Diet

Sponsor

University of Giessen (Other)

Overall Status

Completed

CT.gov ID

NCT03753841

Collaborator

(none)

125

Enrollment

Location

Arms

32.1

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia Aspiration Pneumonia Deglutition Disorders Intensive Care Neurological Disorder	Other: Adjustment of oral diet	N/A

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

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 14, 2014

Actual Primary Completion Date :

Sep 3, 2016

Actual Study Completion Date :

Sep 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Adjustment of oral diet 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 Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)
No Intervention: No adjustment of oral diet Patients who have the adequat diet based on FEES findings.

Arm

Intervention/Treatment

Active Comparator: Adjustment of oral diet

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

Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)

No Intervention: No adjustment of oral diet

Patients who have the adequat diet based on FEES findings.