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
About this trial
This is an interventional diagnostic trial for Acute Stroke
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
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
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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