Validation of Aspiration Risk Assessment in Stroke Units

NCT06162910 | Terminated

• 1 other identifier: ARAS-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration-Score (PAS) Penetration-Aspiration-Score (PAS)

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

  Immediately after the intervention

Secondary Outcomes (1)

• Functional Oral Intake Scale-German (FOIS-G)

  Immediately after the intervention

Study Arms (1)

Clinical swallowing exam

EXPERIMENTAL

Patients with acute ischemic stroke

Diagnostic Test: Daniels Water Swallow Test; Diagnostic Test: Flexible Endoscopic Evaluation of Swallowing

Interventions

Daniels Water Swallow Test DIAGNOSTIC_TEST

Clinical water swallow dysphagia screening

Clinical swallowing exam

Flexible Endoscopic Evaluation of Swallowing DIAGNOSTIC_TEST

Endoscopic evaluation of swallowing function

Also known as: FEES

Clinical swallowing exam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen and Marburg, Campus Giessen

Giesen, Hesse, 35392, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Samra Hamzic, PhD

  University Hospital Giessen and Marburg, Campus Giessen

  PRINCIPAL INVESTIGATOR

• Tobias Braun, MD

  University Hospital Giessen and Marburg, Campus Giessen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: February 1, 2018
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

DE (1)