No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
136 (estimated)
Sponsor
Poudre Valley Health System · Other
Who this trial is looking for
This trial is looking for patients with swallowing difficulties due to stroke or trauma. Participants will follow a protocol allowing them to drink plain water while being monitored for safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with a stroke or trauma.
I have orders for restricted or thickened liquids.
I can control my own airway.
You may not be able to join if
I am considered medically fragile by my doctor.
I refuse to take care of my oral health.
I have any decayed teeth or dental disease.
I have an active head or neck cancer.
I am currently on bed rest.
I am feeling lethargic or sedated.
I have a fever of unknown origin.
I have a history of recurrent aspiration pneumonia.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of …
Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Stroke diagnosis or trauma patients being cared for by Trauma \& Acute Care Surgery (TACS) providers
* Current orders for restricted or thickened liquids
* Ability to control their own airway (i.e. airway adjuncts not needed)
Exclusion Criteria:
* Individuals who are medical…
Inclusion Criteria:
* Stroke diagnosis or trauma patients being cared for by Trauma \& Acute Care Surgery (TACS) providers
* Current orders for restricted or thickened liquids
* Ability to control their own airway (i.e. airway adjuncts not needed)
Exclusion Criteria:
* Individuals who are medically fragile, as determined by treating physician, to include diagnosis of sepsis, need for vasopressors, or high oxygenation needs (requiring high-flow nasal cannula, Airvo, or oximask)
* Individuals who refuse oral care, have any decayed teeth or dental disease, or have a documented active oral infection
* Individuals with an advanced progressive neurological condition, active head/neck cancer, or those who are immunosuppressed
* Individuals who are on bed-rest orders
* Individuals who are lethargic or sedated
* Individuals with suspected pre-hospital aspiration event and/or aspiration pneumonitis
* Individuals with a fever of unknown origin
* Individuals with a history of recurrent aspiration pneumonia/pneumonitis
* Individuals whose primary language is one that the questionnaires are not available in a validated format
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