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Investigation of a Free Water Protocol
Who can join
Ages 18 and older · All sexes
Full 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 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
About the study
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.
What is being tested
- Free Water Protocol (other)
- Control / Standard Care (other)
Sponsor: Poudre Valley Health System · Participants: 136 · Started: Oct 22, 2024
Contact the study team
- Emily Main, MS · Phone: 970-624-4369
Official record on ClinicalTrials.gov — NCT06309602
Locations in the U.S.
| Colorado | Medical Center of the Rockies, Loveland (Not yet recruiting) Medical Center of the Rockies, Loveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.