136 Participants Needed

Free Water Protocol for Swallowing Disorders

EM
Overseen ByEmily Main, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Poudre Valley Health System
Must be taking: Thickened liquids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether drinking plain water, instead of thickened liquids, can improve the quality of life for individuals with swallowing difficulties after a stroke or injury. The researchers aim to determine if this approach, known as the Free Water Protocol, enhances patient satisfaction and maintains oral health without increasing pneumonia risk. Participants will either follow standard care with thickened liquids or try the new protocol with plain water. Ideal candidates have experienced a stroke or trauma, currently require thickened liquids, and can manage their own airway independently. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance the quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Free Water Protocol is safe for swallowing disorders?

Research has shown that the Free Water Protocol (FWP) is generally well-tolerated by individuals with swallowing difficulties. In past studies, the FWP improved hydration, quality of life, and swallowing ability without significantly increasing lung issues like aspiration pneumonia. Aspiration pneumonia occurs when food or liquid accidentally enters the lungs instead of the stomach.

A review of rehabilitation studies, including those involving stroke patients, found no major increase in lung problems from using the FWP. One study demonstrated that allowing patients to drink plain water can be safely done during rehabilitation if certain guidelines are followed.

Overall, these findings suggest that the FWP is safe for individuals with swallowing difficulties, provided proper care is taken.12345

Why are researchers excited about this trial?

Researchers are excited about the Free Water Protocol for swallowing disorders because it challenges the standard approach of using only thickened liquids for patients with swallowing difficulties. The protocol allows patients to drink plain, un-thickened water, provided they wait 30 minutes after meals or medication and complete specific oral care. This method could improve hydration and quality of life for patients while maintaining safety, offering a potentially significant improvement over the restrictive nature of current care options.

What evidence suggests that the Free Water Protocol is effective for swallowing disorders?

Research has shown that the Free Water Protocol (FWP), which participants in this trial may receive, can improve hydration, quality of life related to swallowing, and overall swallowing ability in people with swallowing problems. One study found that FWP safely improved these areas without increasing the risk of aspiration pneumonia, a lung infection from inhaling food or drink. Another review confirmed that using FWP did not lead to more cases of aspiration, making it a safer way for patients to stay hydrated. While some evidence is mixed, many findings suggest that FWP can benefit those with swallowing difficulties.14678

Are You a Good Fit for This Trial?

This trial is for individuals with swallowing disorders or oropharyngeal dysphagia. The eligibility criteria are not fully listed, but typically would include specific diagnostic criteria and health status requirements.

Inclusion Criteria

I am being treated by TACS providers for a stroke or trauma.
Current orders for restricted or thickened liquids
I can breathe on my own without needing help.

Exclusion Criteria

I have had repeated lung infections due to inhaling food or liquid.
I often feel very sleepy or sedated.
I have a fever and the cause is unknown.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive the Free Water Protocol, allowing access to plain water under specific conditions

5 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Free Water Protocol
Trial Overview The study is testing a Free Water Protocol (FWP) against standard care to see if it improves patient satisfaction, doesn't increase pneumonia risk, and betters oral hygiene without causing harm in an acute care setting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Free Water ProtocolExperimental Treatment1 Intervention
Group II: Control / Standard CareExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Poudre Valley Health System

Lead Sponsor

Trials
17
Recruited
780+

Citations

Implementation of a free water protocol at a long term acute ...In this feasibility study, we have shown that the FWP was a safe means for improving hydration, quality of life, and overall swallow function in ...
Implementing the Free Water Protocol Does Not Result in ...This systematic review and meta-analysis investigates the effects of the Frazier Free Water Protocol on outcomes (e.g., hydration, compliance with swallowing ...
A Mixed Methods Systematic Review | DysphagiaFree water protocols (FWP) give patients at risk of aspiration the option to drink water between meals. Evidence is lacking about their use ...
Free Water Protocol for Swallowing DisordersResearch shows that the Free Water Protocol can improve fluid intake, swallowing-related quality of life, and overall swallowing function in patients with ...
Free Water Protocol: Free for who?Limited Evidence: Despite its long history, research on FWP is limited and often shows mixed results. Its effectiveness in preventing aspiration ...
The Frazier Free Water ProtocolThis protocol allows patients with dysphagia to consume water, even though they are at risk of aspirating this water, but aims to minimise ...
Water, Water Everywhere, But Why? Argument Against ...This paper presents the argument against administration of “free water” without consideration of numerous factors besides the presence of dysphagia.
Outcomes of a Pilot Water Protocol Project in ...The results suggest that a trial of oral water access can be safely introduced for rehabilitation patients with documented thin-liquid ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security