Clinical trial NCT04302883: Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
Official title: Transesophageal Echocardiography: Dysphagia Risk in Acute Stroke (T.E.D.R.A.S. Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Dysphagia
Swallowing Disorder
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Secretion severity
timeFrame: Intervention group: One day before TEE; Control group: At least three days before TEE
measure: Secretion severity
timeFrame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
measure: Secretion severity
timeFrame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
measure: Dysphagia severity
timeFrame: Intervention group: One day before TEE; Control group: At least three days before TEE
measure: Dysphagia severity
timeFrame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
measure: Dysphagia severity
timeFrame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
measure: Pharyngeal residue severity
timeFrame: Intervention group: One day before TEE; Control group: At least three days before TEE
measure: Pharyngeal residue severity
timeFrame: Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE
measure: Pharyngeal residue severity
timeFrame: Intervention group: 24 hours after TEE; Control group: At least one day before TEE
Secondary outcomes:
measure: Stroke severity
timeFrame: At the day of admission to hospital and up to 2 weeks after TEE
measure: Degree of disability after stroke
timeFrame: At the day of admission to hospital and up to 2 weeks after TEE
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University Hospital Giessen and Marburg
state: Hessen
Study officials:
affiliation: Department of Neurology, University Hospital Giessen
name: Tibo Gerriets, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.