NCT05173051Completed
Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?
Source: ClinicalTrials.gov · Last updated 6 Mar 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 13 Dec 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 7 Dec 2023
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Diseases
- Stroke
- NCT number
- NCT05173051
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Feb 2022 to the primary completion date, 7 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinic Tulln Coordinator of this site? Confirm its status | Tulln | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.