Actively Recruiting
Investigation of a Free Water Protocol for Patients with Oropharyngeal Dysphagia in Acute Care
Led by Poudre Valley Health System · Updated on 2025-06-05
136
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a Free Water Protocol (FWP) for individuals with difficulty swallowing thin liquids, often prescribed thickened liquids to reduce choking and aspiration pneumonia risks. The study investigates whether allowing access to plain water, combined with strict oral care and timing after meals, improves patient satisfaction and oral hygiene without increasing pulmonary complications. The goal is to balance improved quality of life against potential risks in an acute care setting, with additional qualitative insights from patients and caregivers. Participants will be randomly assigned to either standard care, which includes thickened liquids and oral care twice daily, or the Free Water Protocol group. The FWP group will be allowed plain water intake after completing oral care and waiting 30 minutes post-meal or medication. The protocol includes oral hygiene practices before water intake to reduce pulmonary risk. The study duration for each participant averages 5 days. Throughout the study, patient satisfaction will be assessed using the Dysphagia Handicap Index, and oral hygiene will be measured with the Oral Assessment Guide. Researchers will also collect qualitative data on experiences and monitor for adverse events like aspiration pneumonia. Fluid intake will be tracked, and the study includes interviews with patients and caregivers. The total participation period averages 5 days, focusing on safety and quality of life improvements.
CONDITIONS
Brief Title
Investigation of a Free Water Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of stroke or trauma under Trauma & Acute Care Surgery providers
- Current medical orders for thickened or restricted liquids
- Ability to control own airway without need for breathing aids
You will not qualify if you...
- Medically fragile patients with sepsis, vasopressor use, or high oxygen support
- Refusal of oral care, presence of dental disease, or active oral infection
- Advanced neurological conditions, active head/neck cancer, or immunosuppression
- Bed-rest orders
- Lethargy or sedation
- Suspected pre-hospital aspiration or aspiration pneumonitis
- Fever of unknown origin
- History of recurrent aspiration pneumonia or pneumonitis
- Primary language not supported by validated questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 days
Participants receive either the Free Water Protocol, which allows intake of plain water with specific oral care and timing instructions, or standard care with thickened liquids and oral care.
Daily visits or assessments during treatment
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
Research Team
E
Emily Main, MS
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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