FEES to Determine Neurological Intensive Care Patients' Oral Diet

Not Applicable

Completed

• Conditions: Intensive Care Neurological Disorder; Dysphagia; Aspiration Pneumonia; Deglutition Disorders
• Interventions: Other: Adjustment of oral diet

• Registration Number: NCT03753841
• Lead Sponsor: University of Giessen

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.

Study Timeline

• Study Start: 2014-01-14
• Primary Completion: 2016-09-03
• Study Completion: 2016-09-16
• Status Verified: 2018-11
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-22
• Last Update Submitted: 2018-11-22
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Treatment on neurological ICU
• Clinical suspicion of Dysphagia

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjustment of oral diet	Adjustment of oral diet	Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.

Primary Outcome Measures

Name	Time	Method
Pneumonia Rate	Up to 130 days	self-explanatory
Mortality	Up to 130 days	self-explanatory

Secondary Outcome Measures

Name	Time	Method
Intubation/Tracheotomy	Up to 130 days	Rate of Intubation/Tracheotomy
Length of stay in hospital	Up to 130 days	self-explanatory

Trial Locations

Locations (1)

Universitätsklinikum Gießen; 🇩🇪 Gießen, Hessen, Germany