Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial (TEDRAS2)

Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke, Acute; Dysphagia Following Cerebrovascular Accident
• Intervention / Treatment: Diagnostic test: Flexible Endoscopic Evaluation of Swallowing (FEES) ; Transesophageal Ecocardiography (TEE)

Detailed Description

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.

Early detection of dysphagia increases the overall outcome, reduces the mortality risk, the risk of aspiration pneumonia, malnutrition as well as the length of hospitalization and the overall costs of treatment.

In German stroke units within 24 hours of admission stroke patients undergo a clinical swallowing screening and the flexible endoscopic evaluation of swallowing (FEES), if necessary. FEES allows for a valid assessment of swallowing and description of dysphagia symptoms via standardized scores as the Secretion Severity Sating Scale (SSRS), the Penetration-Aspirations-Scale (PAS), the Yale Pharyngeal Residue Severity Scale (YSPRSS) and the Functional Oral Intake Scale (FOIS-G).

Transesophageal echocardiography (TEE) is conducted within the first few days after stroke as a routine examination to detect whether a cardiac disorder was the cause of stroke. The implementation of a TEE during cardiac surgery has a significant correlation with occurrences of postoperative dysphagia in patients after cardiac surgery [1].

TEDRAS-Trial (Transesophageal Echocardiography: Dysphagia Risk in the Acute Phase After Stroke; ClinTrial.gov identifier NCT04302883) [2] 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 [2].

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.

In particular, the following parameters will be examined:

1. The influence of the type and route (intravenous vs. oral) of anesthesia administered during TEE on swallowing in all cohorts studied.
2. The correlation between the duration of TEE and the degree of deterioration in FOIS-G after TEE.
3. The interrater reliability for the FEES.
4. Definition of typical dysphagia symptoms after TEE.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Samra Hamzic, Dr; Phone Number: +4917699807230; Email: samra.hamzic@neuro.med.uni-giessen.de

Study Locations

• Germany
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Recruiting
      • University Hospital Giessen and Marburg
      • Contact: Samra Hamzic, M.A.; Phone Number: +49 17699807230; Email: samra.hamzic@neuro.med.uni-giessen.de
      • Sub-Investigator: Samra Hamzic, M.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with acute ischemic stroke and indication for TEE

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Samra Hamzic, Dr, University Hospital Giessen and Marburg, Campus Giessen

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

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; Ischemic Stroke; Deglutition Disorders
• Other Study ID Numbers: TEDRAS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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