Tests a free water protocol for people with swallowing difficulty
Tests whether allowing plain water by mouth helps adults with swallowing difficulty.
Plain-language title generated from the registry record
Registry title: Investigation of a Free Water Protocol
Key facts
- Where
- Loveland, United StatesSee the site
Where in United States
- Medical Center of the RockiesLoveland, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Poudre Valley Health System
- Trial code
- NCT06309602
- Record updated
- 5 June 2025
- Original description
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.Read full original descriptionShow less
Investigation of a Free Water Protocol
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.
Inclusion: 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: 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 with suspected pre-hospital aspiration event and/or aspiration pneumonitis; Individuals with a history of recurrent aspiration pneumonia/pneumonitis; 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 are on bed-rest orders; Individuals who are lethargic or sedated; Individuals with a fever of unknown origin; Individuals whose primary language is one that the questionnaires are not available in a validated format.