Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?

NCT05173051 | Completed

• 1 other identifier: 11TS003721
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In a prospective, quantitative explorative study, the risk of aspiration and penetration when swallowing solid pills (placebo) compared to a crushed placebo pill will be evaluated during a routine Fiberoptic Endoscopic Evaluation of Swallowing (FEES). The study design is thus a quasi-experimental study design with repeated measurements in the sense of a pre-posttest. Each patient undergoes a baseline examination (routine procedure) followed by the intervention (administration of three different solid pills and a crushed pill).

Conditions

Cerebral Infarction; Stroke, Acute; Stroke; Dysphagia

Keywords

Stroke, Acute; Cerebral Infarction; acute first insult; medication intake in dysphagia; Dysphagia; pill dysphagia

Outcome Measures

Primary Outcomes (2)

• Penetration Aspiration Scale (PAS) ≥ 3 for each solid placebo and for the crushed placebo in comparison.

  Penetration Aspiration Scale (PAS) is measured during the Swallow endoscopy (FEES). The PAS is a measure of the penetration and aspiration of a bolus. Scala ranges from 1-8. 1. Material does not enter the airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway 6. Material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject

  Immediately after the intervention

• Penetration Aspiration Scale (PAS) ≥ 3 for the accompanying bolus

  Penetration Aspiration Scale (PAS) is measured during the Swallow endoscopy (FEES). The PAS is a measure of the penetration and aspiration of a bolus. Scala ranges from 1-8. 1. Material does not enter the airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway 6. Material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject

  Immediately after the intervention

Secondary Outcomes (1)

• FEES-based graduation of ability to swallow oral solid medication

  Immediately after the intervention

Study Arms (1)

Ability of Swallowing solid placebos vs. a crushed placebo

EXPERIMENTAL

During routine FEES examination, patients are sequentially being given 3 different solid placebos pills and one crushed placebo mixed with semisolid texture.

Other: Solid Medication intake vs. crushed medication intake

Interventions

Solid Medication intake vs. crushed medication intake OTHER

The swallowing ability for solid and crushed medications in stroke patients is evaluated.

Also known as: Medication Intake of Solid Dosage Forms

Ability of Swallowing solid placebos vs. a crushed placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients between 50 and 90 years of age who are admitted to the stroke unit of the neurology department at the University Hospital of Tulln with an acute first stroke, who have a Gugging Swallowing Screen (GUSS) result of less than 20 points, and who give written consent to participate in the study, are consecutively included. In addition, there must be a need for endoscopy (FEES), based on the screening result and the clinical swallowing examination.

You may not qualify if:

• All patients with additional neurodegenerative diseases, with re-stroke, all patients in the time window of 2 hours after extubation, tracheostomy, chronic obstructive pulmonary disease (COPD), patients with pre-existing dysphagia and with pre-existing tablet swallowing problems are excluded. All patients who are not eligible for FEES (Fiberoptic Endoscopic Evaluation of Swallowing) are also excluded. This includes the following diagnoses: Skull base fractures / facial fractures, severe, life-threatening epistaxis in the last 6 weeks, nasal cavity trauma, nasal and paranasal surgery, nasal and paranasal injury in the last 6 weeks, sinus nasal tumours, skull base tumours / surgery, nasopharyngeal stenoses, craniofacial anomalies, Osler's disease (hereditary haemorrhagic telangiectasia), known vasovagal episodes.

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• Paracelsus Medical University: collaborator

Study Sites (1)

University Clinic Tulln

Tulln, Lower Austria, 3430, Austria

Location

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Related Links

• NICEGUIDLINE (NG128). 2019. Stroke and transient ischaemic attack in over 16s: diagnosis and initial management \[Online\]. Available:
• Tips for Swallowing Pills \[Online\] OSMAN, J. 2017. Available: \[Accessed\].
• THE NATIONAL LIBRARY OF MEDICINE. 2020. ClinicalTrials.gov \[Online\]. Available:\[Accessed\].
• Research Randomizer \[Online\] URBANIAK, G. C. \& PLOUS, S. 2020. Available:

MeSH Terms

Conditions

Cerebral Infarction; Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Walter Struhal, Prof. Dr

  University Clinic Tulln

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi-experimental study

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 29, 2021
• Study Start: February 1, 2022
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)