Investigation of a Free Water Protocol
Recruiting now · Not applicable
Conditions studied: Oropharyngeal Dysphagia
In brief
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.
Key facts
- Study ID
- NCT06309602
- Run by
- Poudre Valley Health System
- People needed
- 136
- Starts
- 2024-10-22
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
- Medical Center of the Rockies — Loveland, Colorado, United States
Full record on ClinicalTrials.gov
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