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

Primary Purpose

Acute Stroke, Dysphagia, Swallowing Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transesophageal Echocardiography (TEE)
Flexible Endoscopic Evaluation of Swallowing
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Giessen and Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

TEE FEES

FEES

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 19, 2020
Last Updated
March 6, 2020
Sponsor
University of Giessen
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1. Study Identification

Unique Protocol Identification Number
NCT04302883
Brief Title
Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
Acronym
TEDRAS
Official Title
Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2013 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Giessen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke, Dysphagia, Swallowing Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
TEE FEES
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
FEES
Intervention Type
Diagnostic Test
Intervention Name(s)
Transesophageal Echocardiography (TEE)
Intervention Description
Ultrasound of heart chambers via esophagus
Intervention Type
Diagnostic Test
Intervention Name(s)
Flexible Endoscopic Evaluation of Swallowing
Intervention Description
Endoscopical swallowing study
Primary Outcome Measure Information:
Title
Secretion severity
Description
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
Title
Secretion severity
Description
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
Title
Secretion severity
Description
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
Title
Dysphagia severity
Description
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
Title
Dysphagia severity
Description
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
Title
Dysphagia severity
Description
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
Title
Pharyngeal residue severity
Description
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
Title
Pharyngeal residue severity
Description
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
Title
Pharyngeal residue severity
Description
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 Outcome Measure Information:
Title
Stroke severity
Description
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
Title
Degree of disability after stroke
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibo Gerriets, MD
Organizational Affiliation
Department of Neurology, University Hospital Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Giessen and Marburg
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2564884
Citation
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.
Results Reference
background
PubMed Identifier
7637370
Citation
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.
Results Reference
background

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

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