Validation of Aspiration Risk Assessment in Stroke Units (ARAS)

January 31, 2024 updated by: University of Giessen

Aspiration Risk in Stroke Units. Validation of Clinical Investigation Procedures for Risk Stratification

The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard".

Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians.

Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Giesen, Hessen, Germany, 35392
        • University Hospital Giessen and Marburg, Campus Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute (maximum 7 days old) cerebral infarction detected by cMRI or cCT
  • Neurological deficits
  • Written informed consent

Exclusion Criteria:

  • Cerebral hemorrhage
  • Pre-existing swallowing disorders of other etiologies
  • Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical swallowing exam
Patients with acute ischemic stroke
Diagnostic test: Daniels Water Swallow Test
Clinical water swallow dysphagia screening
Diagnostic test: Flexible Endoscopic Evaluation of Swallowing
Endoscopic evaluation of swallowing function
Other Names:
  • FEES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)
Time Frame: Immediately after the intervention
Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Oral Intake Scale-German (FOIS-G)
Time Frame: Immediately after the intervention
Functional Oral Intake Scale - German Version; minimum value 1, maximum value 7; higher scores mean better outcome
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Principal Investigator: Samra Hamzic, PhD, University Hospital Giessen and Marburg, Campus Giessen
  • Study Director: Tobias Braun, MD, University Hospital Giessen and Marburg, Campus Giessen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARAS-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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