FEES to Determine Neurological Intensive Care Patients' Oral Diet

November 22, 2018 updated by: Tobias Braun, University of Giessen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Universitätsklinikum Gießen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment on neurological ICU
  • Clinical suspicion of Dysphagia

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Principal Investigator: Tobias Braun, M.D., University of Gießen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2014

Primary Completion (Actual)

September 3, 2016

Study Completion (Actual)

September 16, 2016

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 22, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 22, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI 208/16-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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