Investigation of a Free Water Protocol
ConditionOropharyngeal Dysphagia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoudre Valley Health System
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Free Water Protocol
- Control / Standard Care
Treatment groups
136 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov