Dysphagia After Transesophageal Echocardiography in Acute Stroke - Follow Up Trial
Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
University of Giessen
40 participants
May 1, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Acute cerebral infarction detected by cMRI or cCT
- Indication for TEE
- Neurological deficits
- Written informed consent
Exclusion Criteria2
- Cerebral hemorrhage
- Contraindications to FEES (lack of alertness as well as lack of compliance)
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06195501