FEES to Determine Neurological Intensive Care Patients' Oral Diet

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753841
• Other study ID #: GI 208/16-1
• Status: Completed
• Phase: N/A
• Start date: January 14, 2014
• Est. completion date: September 16, 2016

Study information

• Verified date: November 2018
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 16, 2016
• Est. primary completion date: September 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treatment on neurological ICU

• Clinical suspicion of Dysphagia

Exclusion Criteria:

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Deglutition Disorders
• Disease
• Dysphagia
• Intensive Care Neurological Disorder
• Nervous System Diseases
• Pneumonia
• Pneumonia, Aspiration

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Gießen	Gießen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia Rate	self-explanatory	Up to 130 days
Primary	Mortality	self-explanatory	Up to 130 days
Secondary	Length of stay in hospital	self-explanatory	Up to 130 days
Secondary	Intubation/Tracheotomy	Rate of Intubation/Tracheotomy	Up to 130 days