Cerebral InfarctionMedISIDNCT05173051
Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?
A study testing Solid Medication intake vs. crushed medication intake in people with Cerebral Infarction and Stroke, Acute, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cerebral Infarction, Stroke, Acute, Stroke
- What is being tested?
- Solid Medication intake vs. crushed medication intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2022to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
In the research landscape, the topic of medication intake in patients with dysphagia has generally received very little attention, which is why hardly any recommendations can be found in the current guidelines. In the national guidelines of the National Institute for Health and Care Excellence (NICE), the following paragraph was added in 2019: "People with acute stroke who are unable to take adequate nutrition, fluids and medication orally should have their oral medication reviewed to amend either the formulation or the route of administration". In the studies by Kelly and colleagues, dysphagia patients were up to three times more likely to receive an erroneous medication administration than patients without dysphagia. It is therefore currently completely unclear how solid medications can be administered safely in patients with acute dysphagia. There is a complete lack of scientific research in this area which means that the way solid medications are administered to patients with dysphagia is based solely on medical and/or nursing experience.
In everyday clinical practice, solid medications are often delivered in a crushed form to make them easier for patients to swallow. This practice is not evidence-based and has no scientific foundation. There is not a single study known to the author that has systematically investigated the swallowability of crushed medications using an instrumental procedure. Thus, there is an urgent need for research to investigate whether crushed pills can be swallowed better than solid medications by using semisolid textures. This research focuses mainly on the stroke population.
Research questions:
Based on the current state of research and the research gap presented, an overarching research question emerges: "Do patients with acute stroke and recent dysphagia also have a swallowing dysfunction for solid medications? Two subprojects are planned to answer the overall research question: A questionnaire analysis and a clinical experimental study.
The questionnaire analysis serves as a first orientation on how the topic is handled on the stroke units. One question in the questionnaire is aimed at finding out which bolus is most frequently used for the administration of medication. The clinical trial is then conducted with this result.
In a clinical quasi-experimental study, the swallowing ability of placebo medication in patients with dysphagia will be assessed using Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
Primary research question "Questionnaire study" "How is medication administration on stroke units, based on dysphagia screening currently performed?" Primary research questions "Clinical study" Is there a different aspiration-penetration risk when swallowing solid medication and when swallowing crushed medication?
Methods:
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 Swallowing Examination (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). Randomisation is not foreseen in a quasi-experimental study or in an evaluation study.
Inclusion/exclusion criteria In this part of the study, 60 patients between 50 and 90 years of age who are admitted to the stroke unit of the neurology department at the University Hospital Tulln with an acute first insult, who have a 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, based on the screening result and the clinical swallowing examination.
All patients with additional neurodegenerative diseases, with re-insult, all patients in the time window of 2 hours after extubation, tracheotomy, COPD, patients with pre-existing dysphagia and with pre-existing swallowing problems with tablet swallowing are excluded. All patients who are not eligible for swallow endoscopy are also excluded.
- Conditions
- Cerebral Infarction, Stroke, Acute, Stroke, Dysphagia
- Being tested
- Solid Medication intake vs. crushed medication intake
- Keywords
- Stroke, Acute, Cerebral Infarction, acute first insult, medication intake in dysphagia, Dysphagia, pill dysphagia
- Medical subject headings
- Cerebral Infarction, Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solid Medication intake vs. crushed medication intakeOther
Also called Medication Intake of Solid Dosage Forms
The swallowing ability for solid and crushed medications in stroke patients is evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Solid Medication intake vs. crushed medication intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Material does not enter the airway
- Material enters the airway, remains above the vocal folds, and is ejected from the airway
- Material enters the airway, remains above the vocal folds, and is not ejected from the airway
- Material enters the airway, contacts the vocal folds, and is ejected from the airway
- Material enters the airway, contacts the vocal folds, and is not ejected from the airway
- Material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway
- Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort
- Material enters the airway, passes below the vocal folds, and no effort is made to eject
Measured: 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.
- Material does not enter the airway
- Material enters the airway, remains above the vocal folds, and is ejected from the airway
- Material enters the airway, remains above the vocal folds, and is not ejected from the airway
- Material enters the airway, contacts the vocal folds, and is ejected from the airway
- Material enters the airway, contacts the vocal folds, and is not ejected from the airway
- Material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway
- Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort
- Material enters the airway, passes below the vocal folds, and no effort is made to eject
Measured: Immediately after the intervention
Secondary outcomes (1)
FEES-based graduation of ability to swallow oral solid medication
This is a 4 point severity rating scale modified after Buhmann et al. 2019
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Feb 2022
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University
- Responsible party
- Principal investigator, Michaela Trapl-Grundschober, Karl Landsteiner University of Health Sciences
- Investigators
- Walter Struhal, Prof. Dr, Study chair, University Clinic Tulln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173051
- Sponsor's protocol ID
- 11TS003721
- Acronym
- MedISID
- Status last verified
- Mar 2024
- First submitted
- 13 Dec 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Khaled M, Matthis C, Binder A, Mudter J, Schattschneider J, Pulkowski U, Strohmaier T, Niehoff T, Zybur R, Eggers J, Valdueza JM, Royl G; for QugSS II Group. Dysphagia in Patients with Acute Ischemic Stroke: Early Dysphagia Screening May Reduce Stroke-Related Pneumonia and Improve Stroke Outcomes. Cerebrovasc Dis. 2016;42(1-2):81-9. doi: 10.1159/000445299. Epub 2016 Apr 13.
PubMed 27074007Arnold M, Liesirova K, Broeg-Morvay A, Meisterernst J, Schlager M, Mono ML, El-Koussy M, Kagi G, Jung S, Sarikaya H. Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome. PLoS One. 2016 Feb 10;11(2):e0148424. doi: 10.1371/journal.pone.0148424. eCollection 2016.
PubMed 26863627Baijens LW, Clave P, Cras P, Ekberg O, Forster A, Kolb GF, Leners JC, Masiero S, Mateos-Nozal J, Ortega O, Smithard DG, Speyer R, Walshe M. European Society for Swallowing Disorders - European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome. Clin Interv Aging. 2016 Oct 7;11:1403-1428. doi: 10.2147/CIA.S107750. eCollection 2016.
PubMed 27785002Bray BD, Smith CJ, Cloud GC, Enderby P, James M, Paley L, Tyrrell PJ, Wolfe CD, Rudd AG; SSNAP Collaboration. The association between delays in screening for and assessing dysphagia after acute stroke, and the risk of stroke-associated pneumonia. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):25-30. doi: 10.1136/jnnp-2016-313356. Epub 2016 Jun 13.
PubMed 27298147Buhmann C, Bihler M, Emich K, Hidding U, Potter-Nerger M, Gerloff C, Niessen A, Flugel T, Koseki JC, Nienstedt JC, Pflug C. Pill swallowing in Parkinson's disease: A prospective study based on flexible endoscopic evaluation of swallowing. Parkinsonism Relat Disord. 2019 May;62:51-56. doi: 10.1016/j.parkreldis.2019.02.002. Epub 2019 Feb 4.
PubMed 30770254Carnaby-Mann G, Crary M. Pill swallowing by adults with dysphagia. Arch Otolaryngol Head Neck Surg. 2005 Nov;131(11):970-5. doi: 10.1001/archotol.131.11.970.
PubMed 16301368CARRIER, M. 2019. Wissenschaftstheorie zur Einführung, Junius Verlag.
Cichero JA. Thickening agents used for dysphagia management: effect on bioavailability of water, medication and feelings of satiety. Nutr J. 2013 May 1;12:54. doi: 10.1186/1475-2891-12-54.
PubMed 23634758Cichero JA, Lam P, Steele CM, Hanson B, Chen J, Dantas RO, Duivestein J, Kayashita J, Lecko C, Murray J, Pillay M, Riquelme L, Stanschus S. Development of International Terminology and Definitions for Texture-Modified Foods and Thickened Fluids Used in Dysphagia Management: The IDDSI Framework. Dysphagia. 2017 Apr;32(2):293-314. doi: 10.1007/s00455-016-9758-y. Epub 2016 Dec 2.
PubMed 27913916Marquis J, Schneider MP, Payot V, Cordonier AC, Bugnon O, Hersberger KE, Arnet I. Swallowing difficulties with oral drugs among polypharmacy patients attending community pharmacies. Int J Clin Pharm. 2013 Dec;35(6):1130-6. doi: 10.1007/s11096-013-9836-2. Epub 2013 Aug 21.
PubMed 23963541DÖRING, N. & BORTZ, J. 2016. Forschungsmethoden und Evaluation. Wiesbaden: Springerverlag.
Dziewas R, Auf dem Brinke M, Birkmann U, Brauer G, Busch K, Cerra F, Damm-Lunau R, Dunkel J, Fellgiebel A, Garms E, Glahn J, Hagen S, Held S, Helfer C, Hiller M, Horn-Schenk C, Kley C, Lange N, Lapa S, Ledl C, Lindner-Pfleghar B, Mertl-Rotzer M, Muller M, Neugebauer H, Ozsucu D, Ohms M, Perniss M, Pfeilschifter W, Plass T, Roth C, Roukens R, Schmidt-Wilcke T, Schumann B, Schwarze J, Schweikert K, Stege H, Theuerkauf D, Thomas RS, Vahle U, Voigt N, Weber H, Werner CJ, Wirth R, Wittich I, Woldag H, Warnecke T. Safety and clinical impact of FEES - results of the FEES-registry. Neurol Res Pract. 2019 Apr 26;1:16. doi: 10.1186/s42466-019-0021-5. eCollection 2019.
PubMed 33324882DZIEWAS, R. & PFLUG, C. 2020. Neurogene Dysphagie, S1-Leitlinie, 2020 [Online]. Deutsche Gesellschaft für Neurologie (Hrsg.) Available: www.dgn.org/leitlinien [Accessed 2020].
Fields J, Go JT, Schulze KS. Pill Properties that Cause Dysphagia and Treatment Failure. Curr Ther Res Clin Exp. 2015 Aug 20;77:79-82. doi: 10.1016/j.curtheres.2015.08.002. eCollection 2015 Dec.
PubMed 26543509Forough AS, Lau ET, Steadman KJ, Cichero JA, Kyle GJ, Serrano Santos JM, Nissen LM. A spoonful of sugar helps the medicine go down? A review of strategies for making pills easier to swallow. Patient Prefer Adherence. 2018 Jul 26;12:1337-1346. doi: 10.2147/PPA.S164406. eCollection 2018.
PubMed 30100710
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?
- ClinicalTrials.gov ID
- NCT05173051
- Acronym / sponsor ID
- MedISID / 11TS003721
- Conditions
- Cerebral Infarction, Stroke, Acute, Stroke, Dysphagia
- Keywords
- Stroke, Acute, Cerebral Infarction, acute first insult, medication intake in dysphagia, Dysphagia, pill dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In the research landscape, the topic of medication intake in patients with dysphagia has generally received very little attention, which is why hardly any recommendations can be found in the current guidelines. In the national guidelines of the National Institute for Health and Care Excellence (NICE), the following paragraph was added in 2019: "People with acute stroke who are unable to take adequate nutrition, fluids and medication orally should have their oral medication reviewed to amend either the formulation or the route of administration". In the studies by Kelly and colleagues, dysphagia patients were up to three times more likely to receive an erroneous medication administration than patients without dysphagia. It is therefore currently completely unclear how solid medications can be administered safely in patients with acute dysphagia. There is a complete lack of scientific research in this area which means that the way solid medications are administered to patients with dysphagia is based solely on medical and/or nursing experience.
In everyday clinical practice, solid medications are often delivered in a crushed form to make them easier for patients to swallow. This practice is not evidence-based and has no scientific foundation. There is not a single study known to the author that has systematically investigated the swallowability of crushed medications using an instrumental procedure. Thus, there is an urgent need for research to investigate whether crushed pills can be swallowed better than solid medications by using semisolid textures. This research focuses mainly on the stroke population.
Research questions:
Based on the current state of research and the research gap presented, an overarching research question emerges: "Do patients with acute stroke and recent dysphagia also have a swallowing dysfunction for solid medications? Two subprojects are planned to answer the overall research question: A questionnaire analysis and a clinical experimental study.
The questionnaire analysis serves as a first orientation on how the topic is handled on the stroke units. One question in the questionnaire is aimed at finding out which bolus is most frequently used for the administration of medication. The clinical trial is then conducted with this result.
In a clinical quasi-experimental study, the swallowing ability of placebo medication in patients with dysphagia will be assessed using Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
Primary research question "Questionnaire study" "How is medication administration on stroke units, based on dysphagia screening currently performed?" Primary research questions "Clinical study" Is there a different aspiration-penetration risk when swallowing solid medication and when swallowing crushed medication?
Methods:
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 Swallowing Examination (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). Randomisation is not foreseen in a quasi-experimental study or in an evaluation study.
Inclusion/exclusion criteria In this part of the study, 60 patients between 50 and 90 years of age who are admitted to the stroke unit of the neurology department at the University Hospital Tulln with an acute first insult, who have a 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, based on the screening result and the clinical swallowing examination.
All patients with additional neurodegenerative diseases, with re-insult, all patients in the time window of 2 hours after extubation, tracheotomy, COPD, patients with pre-existing dysphagia and with pre-existing swallowing problems with tablet swallowing are excluded. All patients who are not eligible for swallow endoscopy are also excluded.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Ability of Swallowing solid placebos vs. a crushed placebo | Experimental | Other: Solid Medication intake vs. crushed medication intakeDuring routine FEES examination, patients are sequentially being given 3 different solid placebos pills and one crushed placebo mixed with semisolid texture. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solid Medication intake vs. crushed medication intakeAlso: Medication Intake of Solid Dosage FormsThe swallowing ability for solid and crushed medications in stroke patients is evaluated. | Other | Ability of Swallowing solid placebos vs. a crushed placebo |
Primary outcome
Penetration Aspiration Scale (PAS) ≥ 3 for each solid placebo and for the crushed placebo in comparison.
Time frame: Immediately after the intervention
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
Penetration Aspiration Scale (PAS) ≥ 3 for the accompanying bolus
Time frame: Immediately after the intervention
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
1 secondary outcome
FEES-based graduation of ability to swallow oral solid medication
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 27074007Al-Khaled M, Matthis C, Binder A, Mudter J, Schattschneider J, Pulkowski U, Strohmaier T, Niehoff T, Zybur R, Eggers J, Valdueza JM, Royl G; for QugSS II Group. Dysphagia in Patients with Acute Ischemic Stroke: Early Dysphagia Screening May Reduce Stroke-Related Pneumonia and Improve Stroke Outcomes. Cerebrovasc Dis. 2016;42(1-2):81-9. doi: 10.1159/000445299. Epub 2016 Apr 13.
- Background: PubMed 26863627Arnold M, Liesirova K, Broeg-Morvay A, Meisterernst J, Schlager M, Mono ML, El-Koussy M, Kagi G, Jung S, Sarikaya H. Dysphagia in Acute Stroke: Incidence, Burden and Impact on Clinical Outcome. PLoS One. 2016 Feb 10;11(2):e0148424. doi: 10.1371/journal.pone.0148424. eCollection 2016.
- Background: PubMed 27785002Baijens LW, Clave P, Cras P, Ekberg O, Forster A, Kolb GF, Leners JC, Masiero S, Mateos-Nozal J, Ortega O, Smithard DG, Speyer R, Walshe M. European Society for Swallowing Disorders - European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome. Clin Interv Aging. 2016 Oct 7;11:1403-1428. doi: 10.2147/CIA.S107750. eCollection 2016.
- Background: PubMed 27298147Bray BD, Smith CJ, Cloud GC, Enderby P, James M, Paley L, Tyrrell PJ, Wolfe CD, Rudd AG; SSNAP Collaboration. The association between delays in screening for and assessing dysphagia after acute stroke, and the risk of stroke-associated pneumonia. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):25-30. doi: 10.1136/jnnp-2016-313356. Epub 2016 Jun 13.
- Background: PubMed 30770254Buhmann C, Bihler M, Emich K, Hidding U, Potter-Nerger M, Gerloff C, Niessen A, Flugel T, Koseki JC, Nienstedt JC, Pflug C. Pill swallowing in Parkinson's disease: A prospective study based on flexible endoscopic evaluation of swallowing. Parkinsonism Relat Disord. 2019 May;62:51-56. doi: 10.1016/j.parkreldis.2019.02.002. Epub 2019 Feb 4.
- Background: PubMed 16301368Carnaby-Mann G, Crary M. Pill swallowing by adults with dysphagia. Arch Otolaryngol Head Neck Surg. 2005 Nov;131(11):970-5. doi: 10.1001/archotol.131.11.970.
- BackgroundCARRIER, M. 2019. Wissenschaftstheorie zur Einführung, Junius Verlag.
- Background: PubMed 23634758Cichero JA. Thickening agents used for dysphagia management: effect on bioavailability of water, medication and feelings of satiety. Nutr J. 2013 May 1;12:54. doi: 10.1186/1475-2891-12-54.
- Background: PubMed 27913916Cichero JA, Lam P, Steele CM, Hanson B, Chen J, Dantas RO, Duivestein J, Kayashita J, Lecko C, Murray J, Pillay M, Riquelme L, Stanschus S. Development of International Terminology and Definitions for Texture-Modified Foods and Thickened Fluids Used in Dysphagia Management: The IDDSI Framework. Dysphagia. 2017 Apr;32(2):293-314. doi: 10.1007/s00455-016-9758-y. Epub 2016 Dec 2.
- Background: PubMed 23963541Marquis J, Schneider MP, Payot V, Cordonier AC, Bugnon O, Hersberger KE, Arnet I. Swallowing difficulties with oral drugs among polypharmacy patients attending community pharmacies. Int J Clin Pharm. 2013 Dec;35(6):1130-6. doi: 10.1007/s11096-013-9836-2. Epub 2013 Aug 21.
- BackgroundDÖRING, N. & BORTZ, J. 2016. Forschungsmethoden und Evaluation. Wiesbaden: Springerverlag.
- Background: PubMed 33324882Dziewas R, Auf dem Brinke M, Birkmann U, Brauer G, Busch K, Cerra F, Damm-Lunau R, Dunkel J, Fellgiebel A, Garms E, Glahn J, Hagen S, Held S, Helfer C, Hiller M, Horn-Schenk C, Kley C, Lange N, Lapa S, Ledl C, Lindner-Pfleghar B, Mertl-Rotzer M, Muller M, Neugebauer H, Ozsucu D, Ohms M, Perniss M, Pfeilschifter W, Plass T, Roth C, Roukens R, Schmidt-Wilcke T, Schumann B, Schwarze J, Schweikert K, Stege H, Theuerkauf D, Thomas RS, Vahle U, Voigt N, Weber H, Werner CJ, Wirth R, Wittich I, Woldag H, Warnecke T. Safety and clinical impact of FEES - results of the FEES-registry. Neurol Res Pract. 2019 Apr 26;1:16. doi: 10.1186/s42466-019-0021-5. eCollection 2019.
- NICEGUIDLINE (NG128). 2019. Stroke and transient ischaemic attack in over 16s: diagnosis and initial management \[Online\]. Available:Link provided by the sponsor.
- Tips for Swallowing Pills \[Online\] OSMAN, J. 2017. Available: \[Accessed\].Link provided by the sponsor.
- THE NATIONAL LIBRARY OF MEDICINE. 2020. ClinicalTrials.gov \[Online\]. Available:\[Accessed\].Link provided by the sponsor.
- Research Randomizer \[Online\] URBANIAK, G. C. \& PLOUS, S. 2020. Available:Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Struhal, Prof. Dr study chair
University Clinic Tulln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solid Medication intake vs. crushed medication intake in people with Cerebral Infarction and Stroke, Acute, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (PAS) ≥ 3 for each solid placebo and for the crushed placebo in comparison. (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173051, which also lists 70 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.