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

March 5, 2024 updated by: Michaela Trapl-Grundschober, Karl Landsteiner University of Health Sciences
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Lower Austria
      • Tulln, Lower Austria, Austria, 3430
        • University Clinic Tulln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ability of Swallowing solid placebos vs. a crushed placebo
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
The swallowing ability for solid and crushed medications in stroke patients is evaluated.
Other Names:
  • Medication Intake of Solid Dosage Forms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after the intervention
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
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEES-based graduation of ability to swallow oral solid medication
Time Frame: Immediately after the intervention
This is a 4 point severity rating scale modified after Buhmann et al. 2019
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karl Landsteiner University of Health Sciences

Collaborators

Paracelsus Medical University

Investigators

  • Study Chair: Walter Struhal, Prof. Dr, University Clinic Tulln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

December 7, 2023

Study Completion (Actual)

December 7, 2023

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 26, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11TS003721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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