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Completed

NCT Number: NCT04302883

Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)

The prevalence of dysphagia in acute stroke patients undergoing transesophageal echocardiography (TEE) is unknown. The aim of this study was to assess for the first time whether TEE has a negative influence on swallowing in acute stroke patients.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Swallowing Disorder Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Giessen and Marburg

Giessen, Hesse, 35392, Germany

About this study

Dysphagia is common in patients with acute stroke and deteriorates the overall outcome (1). Transesophageal echocardiography (TEE) is a routine examination in the diagnostic workup of stroke etiology. In cardiac surgery it is known as cause of postoperative dysphagia (2).

Using flexible endoscopic evaluation of swallowing (FEES) T.E.D.R.A.S., as a prospective, blinded, randomized and controlled study, includes patients in two groups in order to test the influence of TEE on swallowing in acute stroke: an intervention group and a control group. FEES is performed for analysis of swallowing in the intervention group (1) one day before TEE, (2) 2-4 hours after TEE, (3) 24 hours after TEE. In the control group FEES is performed on three consecutive days with TEE taking place any time after the last FEES. Validated scores assess dysphagia severity in both groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • acute stroke (max. 7 days post-onset) as displayed by a cranial computed tomography (CT) or magnetic resonance imaging (MRI)
  • written informed consent either by patients themselves or by a legal representative
  • indication for TEE

Exclusion criteria

  • brain hemorrhage
  • either pre-existing neurogenic dysphagia or
  • head-and-neck cancer induced dysphagia
  • dementia
  • aphasia with an impairment in language comprehension

Treatment and study plan

Transesophageal Echocardiography (TEE)

Diagnostic Test

Ultrasound of heart chambers via esophagus

Flexible Endoscopic Evaluation of Swallowing

Diagnostic Test

Endoscopical swallowing study

Primary outcomes

  1. Secretion severity

    Time frame: Intervention group: One day before TEE; Control group: At least three days before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome

  2. Secretion severity

    Time frame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome

  3. Secretion severity

    Time frame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome

  4. Dysphagia severity

    Time frame: Intervention group: One day before TEE; Control group: At least three days before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome

  5. Dysphagia severity

    Time frame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome

  6. Dysphagia severity

    Time frame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome

  7. Pharyngeal residue severity

    Time frame: Intervention group: One day before TEE; Control group: At least three days before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome

  8. Pharyngeal residue severity

    Time frame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome

  9. Pharyngeal residue severity

    Time frame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE

    Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome

Secondary outcomes

  1. Stroke severity

    Time frame: At the day of admission to hospital and up to 2 weeks after TEE

    Quantification of stroke severity via National Institutes of Health Stroke Scale (NIHSS):

    Minimum value: 0 Maximum value: 42 Higher scores mean worse outcome

  2. Degree of disability after stroke

    Time frame: At the day of admission to hospital and up to 2 weeks after TEE

    Measuring the degree of disability or dependance of stroke survivors as measured by the Modified Rankin Scale (MRS):

    Minimum value: 0 Maximum value: 6 Higher scores mean worse outcome

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Acronym: TEDRAS

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2020
Registry last updated
Mar 10, 2020

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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