NCT06195501|Unknown
Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial
TEDRAS2
Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
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TEDRAS2
Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
Sponsor study identifier
observational
40
1 country
1
Study Start
May 1, 2023
Actual (reported)Primary Completion
May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute Dysphagia is a common consequence from ischemic stroke and it correlates with an increased risk of pulmonary complications such as aspiration pneumonia and an increased mortality risk. TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) was the first randomized and controlled trial to address the question of the extent to which TEE increases dysphagia risk in acute stroke patients. The results of the study confirmed the hypothesis that dysphagia severity worsens after TEE in the intervention group. The aim of the prospective observational TEDRAS - Follow-up Trial is to investigate the limitations of the initial TEDRAS - Trial in patients with acute ischemic stroke.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2023
Actual (reported)December 22, 2023
Actual (reported)January 8, 2024
Actual (reported)May 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Penetration-Aspiration-Score (PAS)
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Immediately after the intervention
Functional Oral Intake Scale-German (FOIS-G)
Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome
Immediately after the intervention
Yale Scale (YS)
Yale Pharyngeal Residue Severity Rating Scale; minimum value 1, maximum value 5; higher scores mean worse outcome
Immediately after the intervention
Patients with acute ischemic stroke and an indication for a transesophageal ecocardiography
Flexible Endoscopic Evaluation of Swallowing (FEES): FEES is performed for analysis of swallowing ability according to the same methodology as in the initial trial: one day before a TEE and max. 4 hours after TEE. Before the FEES anticongestive nose drops are applied and the nostrils are anaesthetized by applying a lidocaine gel via cotton sticks. During the FEES examination the participants sit upright and are asked to swallow various consistencies: FEES is aborted in case of aspiration of any of the consistencies during the examination. Transesophageal Ecocardiography (TEE): For the TEE anesthesia is applied via intravenous injection of propofol or a combined anesthesia, through intravenous application of propofol and local anesthesia, using lidocaine spray. All patients undergoing a TEE are sober before and at least two to four hours after TEE.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with acute ischemic stroke and indication for TEE
University Hospital Giessen and Marburg
Giessen, Hesse, 35392, Germany
Hamzic S, Braun T, Butz M, Khilan H, Weber S, Yeniguen M, Gerriets T, Schramm P, Juenemann M. Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke (TEDRAS): a prospective, blind, randomized and controlled clinical trial. Eur J Neurol. 2021 Jan;28(1):172-181. doi: 10.1111/ene.14516. Epub 2020 Oct 10.
Hamzic S, Juenemann M, Braun T, Piayda K, Bauer P, Sossalla S, Gerriets T, Khilan H, Butz M, Schramm P, Omar OA. TEDRAS II - transesophageal echocardiography as dysphagia risk in the acute phase of stroke-protocol for a prospective pilot observational trial. Trials. 2025 Oct 27;26(1):445. doi: 10.1186/s13063-025-09065-5.
Samra Hamzic, Dr
University Hospital Giessen and Marburg, Campus Giessen
First Submitted
December 22, 2023
First Posted
January 8, 2024
Study Start
May 1, 2023
Actual (reported)Primary Completion
May 30, 2025
Estimated (date passed)Improving Low ASPECTS Stroke Thrombectomy
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 6, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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