Free water protocol for people with swallowing problems after stroke or trauma
Official title: Investigation of a Free Water Protocol
Run by Poudre Valley Health System · NCT06309602 · Data updated 2026-11-12
This study will try giving plain water with timed oral care to people on thickened-liquid diets after stroke or trauma to see if it improves satisfaction and oral hygiene without increasing lung infections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | Poudre Valley Health System Academic / other |
| Locations | 2 sites (Loveland, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | October 22, 2024 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | June 5, 2025 |
| Trial ID | NCT06309602 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are hospitalized stroke or trauma patients on restricted or thickened-liquid orders who can control their own airway and are not medically fragile.
✕Probably not a fit
Patients who are medically fragile, sedated or lethargic, immunosuppressed, have active oral infection or dental disease, or who have had recent aspiration events are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional comparison gives eligible acute-care stroke or trauma patients access to plain (thin) water under a Free Water Protocol that requires oral care and a 30-minute wait after meals, versus standard thickened-liquid care. Key outcomes include patient satisfaction measured by the Dysphagia Handicap Index, incidence of aspiration pneumonia/pneumonitis, and oral hygiene measured by the Oral Assessment Guide, plus qualitative feedback from patients and caregivers. Participants with orders for restricted or thickened liquids who can control their airway are eligible, while medically fragile or immunosuppressed patients and those with active oral disease are excluded. The protocol aims to balance improved hydration and satisfaction against the potential pulmonary risks of thin water.
Why it matters
Potential benefit: If successful, the protocol could increase patient satisfaction, improve hydration and oral hygiene, and allow safe access to plain water for some patients who otherwise receive only thickened liquids.
How similar studies have gone: Prior inpatient rehabilitation studies have suggested plain water can be given safely under protocols with oral care, but only about ten studies have measured pulmonary complications and methods and results have been inconsistent.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Medical Center of the Rockies
Loveland, Colorado, United States Recruiting -
Medical Center of the Rockies
Loveland, Colorado, United States Not yet recruiting
Study contacts
- Study coordinator: Emily Main, MS
- Email: emily.main@uchealth.org
- Phone: 970-624-4369
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.