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Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial

ConditionsIschemic Stroke, AcuteDysphagia Following Cerebrovascular Accident
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Giessen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute cerebral infarction detected by cMRI or cCT

Indication for TEE

Neurological deficits

Written informed consent

Disqualifiers

Cerebral hemorrhage

Contraindications to FEES (lack of alertness as well as lack of compliance)

Trial population

Patients with acute ischemic stroke and indication for TEE

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Acute ischemic stroke1 intervention

Trial outcomes

Primary outcomes

1

Penetration-Aspiration-Score (PAS)

Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome

Time frame
Immediately after the intervention
2

Functional Oral Intake Scale-German (FOIS-G)

Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome

Time frame
Immediately after the intervention
3

Yale Scale (YS)

Yale Pharyngeal Residue Severity Rating Scale; minimum value 1, maximum value 5; higher scores mean worse outcome

Time frame
Immediately after the intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Giessen

Lead sponsor

Source ClinicalTrials.gov
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