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

Primary Purpose

Cerebral Infarction, Stroke, Acute, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Solid Medication intake vs. crushed medication intake
Sponsored by
Karl Landsteiner University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Infarction focused on measuring Stroke, Acute, Cerebral Infarction, acute first insult, medication intake in dysphagia, Dysphagia, pill dysphagia

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University Clinic TullnRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ability of Swallowing solid placebos vs. a crushed placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

FEES-based graduation of ability to swallow oral solid medication
This is a 4 point severity rating scale modified after Buhmann et al. 2019

Full Information

First Posted
December 13, 2021
Last Updated
July 19, 2023
Sponsor
Karl Landsteiner University of Health Sciences
Collaborators
Paracelsus Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05173051
Brief Title
Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?
Acronym
MedISID
Official Title
Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karl Landsteiner University of Health Sciences
Collaborators
Paracelsus Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction, Stroke, Acute, Stroke, Dysphagia
Keywords
Stroke, Acute, Cerebral Infarction, acute first insult, medication intake in dysphagia, Dysphagia, pill dysphagia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ability of Swallowing solid placebos vs. a crushed placebo
Arm Type
Experimental
Arm Description
During routine FEES examination, patients are sequentially being given 3 different solid placebos pills and one crushed placebo mixed with semisolid texture.
Intervention Type
Other
Intervention Name(s)
Solid Medication intake vs. crushed medication intake
Other Intervention Name(s)
Medication Intake of Solid Dosage Forms
Intervention Description
The swallowing ability for solid and crushed medications in stroke patients is evaluated.
Primary Outcome Measure Information:
Title
Penetration Aspiration Scale (PAS) ≥ 3 for each solid placebo and for the crushed placebo in comparison.
Description
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
Time Frame
Immediately after the intervention
Title
Penetration Aspiration Scale (PAS) ≥ 3 for the accompanying bolus
Description
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
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
FEES-based graduation of ability to swallow oral solid medication
Description
This is a 4 point severity rating scale modified after Buhmann et al. 2019
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michaela Trapl-Grundschober
Phone
+43 2272900422393
Email
michaela.trapl@tulln.lknoe.at
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Caroline Cosendai, PhD
Phone
+43 2272900427840
Email
anne-caroline.cosendai@tulln.lknoe.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Struhal, Prof. Dr
Organizational Affiliation
University Clinic Tulln
Official's Role
Study Chair
Facility Information:
Facility Name
University Clinic Tulln
City
Tulln
State/Province
Lower Austria
ZIP/Postal Code
3430
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Trapl-Grundschober, PhDr. MSc
Phone
+432272900422393
Email
michaela.trapl@tulln.lknoe.at

12. IPD Sharing Statement

Plan to Share IPD
No
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https://www.randomizer.org
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Medication Intake of Solid Dosage Forms: A Risk Factor for Patients With Stroke-induced Dysphagia?

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