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Completed

NCT Number: NCT03753841

FEES to Determine Neurological Intensive Care 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.

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Key information

Conditions

Dysphagia Aspiration Pneumonia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Infections Intensive Care Neurological Disorder Lung Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment on neurological ICU
  • Clinical suspicion of Dysphagia

Exclusion criteria

  • none

Treatment and study plan

Adjustment of oral diet

Other

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

Primary outcomes

  1. Pneumonia Rate

    Time frame: Up to 130 days

    self-explanatory

  2. Mortality

    Time frame: Up to 130 days

    self-explanatory

Secondary outcomes

  1. Length of stay in hospital

    Time frame: Up to 130 days

    self-explanatory

  2. Intubation/Tracheotomy

    Time frame: Up to 130 days

    Rate of Intubation/Tracheotomy

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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