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CompletedNCT04302883TEDRASUpdated Mar 10, 2020

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

An interventional study of Transesophageal Echocardiography (TEE) and Flexible Endoscopic Evaluation of Swallowing in Acute Stroke, Dysphagia and Swallowing Disorder, sponsored by University of Giessen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by University of Giessen · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 years 8 months after the study started (first participant enrolled Jun 2013, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Acute Stroke
  • Dysphagia
  • Swallowing Disorder
03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 34 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University of Giessen is the lead sponsor of 91 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Intervention group

    TEE FEES

    Diagnostic Test: Transesophageal Echocardiography (TEE) · Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

  • Active comparator
    Control group

    FEES

    Diagnostic Test: Transesophageal Echocardiography (TEE) · Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Interventions

  • Diagnostic testTransesophageal Echocardiography (TEE)

    Ultrasound of heart chambers via esophagus

  • Diagnostic testFlexible Endoscopic Evaluation of Swallowing

    Endoscopical swallowing study

06

What researchers measure

Primary outcomes

  1. Secretion severity

    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

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

  2. Secretion severity

    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

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

  3. Secretion severity

    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

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

  4. Dysphagia severity

    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

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

  5. Dysphagia severity

    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

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

  6. Dysphagia severity

    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

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

  7. Pharyngeal residue severity

    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

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

  8. Pharyngeal residue severity

    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

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

  9. Pharyngeal residue severity

    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

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

Secondary outcomes

  1. Stroke severity

    Quantification of stroke severity via National Institutes of Health Stroke Scale (NIHSS): Minimum value: 0 Maximum value: 42 Higher scores mean worse outcome

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

  2. Degree of disability after stroke

    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

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

07

Study locations

1 site
  • University Hospital Giessen and Marburg
    Gießen, Hessen 35392, Germany
08

References and documents

Publications

  • Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. doi: 10.1136/jnnp.52.2.236. PubMed 2564884 ↗
  • Hogue CW Jr, Lappas GD, Creswell LL, Ferguson TB Jr, Sample M, Pugh D, Balfe D, Cox JL, Lappas DG. Swallowing dysfunction after cardiac operations. Associated adverse outcomes and risk factors including intraoperative transesophageal echocardiography. J Thorac Cardiovasc Surg. 1995 Aug;110(2):517-22. doi: 10.1016/S0022-5223(95)70249-0. PubMed 7637370 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04302883
Lead sponsor
University of Giessen
Responsible party
Sponsor
First posted
Mar 10, 2020
Start date
Jun 12, 2013
Primary completion
Sep 5, 2019
Completion
Oct 1, 2019
Last update
Mar 10, 2020

Study contacts

Tibo Gerriets, MD
principal investigator · Department of Neurology, University Hospital Giessen

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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