Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06309602

Investigation of a Free Water Protocol

Led by Poudre Valley Health System · Updated on 2025-06-05

136

Participants Needed

2

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Investigation of a Free Water Protocol

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stroke diagnosis or trauma patients being cared for by Trauma & Acute Care Surgery providers
  • Current orders for restricted or thickened liquids
  • Ability to control their own airway (i.e. airway adjuncts not needed)
Not Eligible

You will not qualify if you...

  • Medically fragile individuals as determined by treating physician, including sepsis, need for vasopressors, or high oxygenation needs (high-flow nasal cannula, Airvo, or oximask)
  • Individuals who refuse oral care, have decayed teeth or dental disease, or have an active oral infection
  • Individuals with advanced progressive neurological condition, active head/neck cancer, or immunosuppression
  • Individuals 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 not available in a validated questionnaire format

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Medical Center of the Rockies

Loveland, Colorado, United States, 80538

Not Yet Recruiting

2

Medical Center of the Rockies

Loveland, Colorado, United States, 80538

Actively Recruiting

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Research Team

E

Emily Main, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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