Clinical trial NCT06195501: Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial
Official title: Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke, Acute
Dysphagia Following Cerebrovascular Accident
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke and indication for TEE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Penetration-Aspiration-Score (PAS)
timeFrame: Immediately after the intervention
measure: Functional Oral Intake Scale-German (FOIS-G)
timeFrame: Immediately after the intervention
measure: Yale Scale (YS)
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University Hospital Giessen and Marburg
state: Hessen
Study officials:
affiliation: University Hospital Giessen and Marburg, Campus Giessen
name: Samra Hamzic, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.