NCT06309602Recruiting
Investigation of a Free Water Protocol
Source: ClinicalTrials.gov · Last updated 5 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 2 Nov 2023
- Start date
- 22 Oct 2024
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Poudre Valley Health System
- Diseases
- Stroke
- NCT number
- NCT06309602
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 22 Oct 2024 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center of the Rockies Coordinator of this site? Confirm its status | Loveland | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.