NCT04302883

Brief Summary

The prevalence of dysphagia in acute stroke patients undergoing transesophageal echocardiography (TEE) is unknown. The aim of this study was to assess for the first time whether TEE has a negative influence on swallowing in acute stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

February 1, 2020

Enrollment Period

6.2 years

First QC Date

February 19, 2020

Last Update Submit

March 6, 2020

Conditions

Acute StrokeDysphagiaSwallowing Disorder

Outcome Measures

Primary Outcomes (9)

  • Secretion severity

    Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome

    Intervention group: One day before TEE; Control group: At least three days before TEE

  • Secretion severity

    Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome

    Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE

  • Secretion severity

    Change in presence and severity of dysphagia examined via FEES and scored by Murray´s Secretions Severity Rating Scale Minimum value: 0 Maximum value: 3 Higher scores mean worse outcome

    Intervention group: 24 hours after TEE; Control group: At least one day before TEE

  • Dysphagia severity

    Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome

    Intervention group: One day before TEE; Control group: At least three days before TEE

  • Dysphagia severity

    Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome

    Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE

  • Dysphagia severity

    Change in presence and severity of dysphagia examined via FEES and scored by Rosenbek´s Penetration-Aspiration-Scale Minimum value: 1 Maximum value: 8 Higher scores mean worse outcome

    Intervention group: 24 hours after TEE; Control group: At least one day before TEE

  • Pharyngeal residue severity

    Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome

    Intervention group: One day before TEE; Control group: At least three days before TEE

  • Pharyngeal residue severity

    Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome

    Intervention group: 2-4 hours after TEE; Control group: At least two days before TEE

  • Pharyngeal residue severity

    Change in presence and severity of dysphagia examined via FEES and scored by Yale Pharyngeal Residue Severity Rating Scale Minimum value: 1 Maximum value: 5 Higher scores mean worse outcome

    Intervention group: 24 hours after TEE; Control group: At least one day before TEE

Secondary Outcomes (2)

  • Stroke severity

    At the day of admission to hospital and up to 2 weeks after TEE

  • Degree of disability after stroke

    At the day of admission to hospital and up to 2 weeks after TEE

Study Arms (2)

Intervention group

EXPERIMENTAL

TEE FEES

Diagnostic Test: Transesophageal Echocardiography (TEE)Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Control group

ACTIVE COMPARATOR

FEES

Diagnostic Test: Transesophageal Echocardiography (TEE)Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Interventions

Transesophageal Echocardiography (TEE)DIAGNOSTIC_TEST

Ultrasound of heart chambers via esophagus

Control groupIntervention group
Flexible Endoscopic Evaluation of SwallowingDIAGNOSTIC_TEST

Endoscopical swallowing study

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute stroke (max. 7 days post-onset) as displayed by a cranial computed tomography (CT) or magnetic resonance imaging (MRI)
  • written informed consent either by patients themselves or by a legal representative
  • indication for TEE

You may not qualify if:

  • brain hemorrhage
  • either pre-existing neurogenic dysphagia or
  • head-and-neck cancer induced dysphagia
  • dementia
  • aphasia with an impairment in language comprehension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Giessen and Marburg

Giessen, Hesse, 35392, Germany

Location

Related Publications (3)

  • Barer DH. The natural history and functional consequences of dysphagia after hemispheric stroke. J Neurol Neurosurg Psychiatry. 1989 Feb;52(2):236-41. doi: 10.1136/jnnp.52.2.236.

    PMID: 2564884BACKGROUND

  • Hogue CW Jr, Lappas GD, Creswell LL, Ferguson TB Jr, Sample M, Pugh D, Balfe D, Cox JL, Lappas DG. Swallowing dysfunction after cardiac operations. Associated adverse outcomes and risk factors including intraoperative transesophageal echocardiography. J Thorac Cardiovasc Surg. 1995 Aug;110(2):517-22. doi: 10.1016/S0022-5223(95)70249-0.

    PMID: 7637370BACKGROUND

  • 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: 41146308DERIVED

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Tibo Gerriets, MD

    Department of Neurology, University Hospital Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

March 10, 2020

Study Start

June 12, 2013

Primary Completion

September 5, 2019

Study Completion

October 1, 2019

Last Updated

March 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)