Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial

NCT06195501 | Recruiting

• 1 other identifier: TEDRAS2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke, Acute; Dysphagia Following Cerebrovascular Accident

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Acute ischemic stroke

Patients with acute ischemic stroke and an indication for a transesophageal ecocardiography

Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)

Interventions

Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE) DIAGNOSTIC_TEST

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.

Acute ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute ischemic stroke and indication for TEE

You may qualify if:

• Acute cerebral infarction detected by cMRI or cCT
• Indication for TEE
• Neurological deficits
• Written informed consent

You may not qualify if:

• Cerebral hemorrhage
• Contraindications to FEES (lack of alertness as well as lack of compliance)

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen and Marburg

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 32897605 RESULT

• 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.

  PMID: 41146308 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Samra Hamzic, Dr

  University Hospital Giessen and Marburg, Campus Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samra Hamzic, Dr

CONTACT

+4917699807230; samra.hamzic@neuro.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: May 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: August 31, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

DE (1)