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

Dysphagia Clinical Trial

— TEDRAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302883
• Other study ID #: TEDRAS-1
• Status: Completed
• Phase: N/A
• Start date: June 12, 2013
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2020
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Deglutition Disorders
• Dysphagia
• Stroke
• Swallowing Disorder

Intervention

Diagnostic Test:
• Transesophageal Echocardiography (TEE)
Ultrasound of heart chambers via esophagus
• Flexible Endoscopic Evaluation of Swallowing
Endoscopical swallowing study

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg	Gießen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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