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

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia; Acute Stroke; Swallowing Disorder
• Intervention / Treatment: Diagnostic test: Flexible Endoscopic Evaluation of Swallowing; Diagnostic test: Transesophageal Echocardiography (TEE)

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • University Hospital Giessen and Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; TEE FEES	Diagnostic test: Flexible Endoscopic Evaluation of Swallowing; Endoscopical swallowing study; Diagnostic test: Transesophageal Echocardiography (TEE); Ultrasound of heart chambers via esophagus
ACTIVE_COMPARATOR: Control group; FEES	Diagnostic test: Flexible Endoscopic Evaluation of Swallowing; Endoscopical swallowing study; Diagnostic test: Transesophageal Echocardiography (TEE); Ultrasound of heart chambers via esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intervention group: One day before TEE; Control group: At least three days before TEE
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	Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
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	Intervention group: 24 hours after TEE; Control group: At least one day before TEE
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	Intervention group: One day before TEE; Control group: At least three days before TEE
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	Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
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	Intervention group: 24 hours after TEE; Control group: At least one day before TEE
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	Intervention group: One day before TEE; Control group: At least three days before TEE
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	Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
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	Intervention group: 24 hours after TEE; Control group: At least one day before TEE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the day of admission to hospital and up to 2 weeks after TEE
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	At the day of admission to hospital and up to 2 weeks after TEE

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Tibo Gerriets, MD, Department of Neurology, University Hospital Giessen

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2013
• Primary Completion (ACTUAL): September 5, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (ACTUAL): March 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: TEDRAS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No