Free Water Protocol for Swallowing Disorders

Overseen By Emily Main, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Poudre Valley Health System

Must be taking: Thickened liquids

Disqualifiers: Sepsis, Immunosuppressed, Sedated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

136 Participants Needed

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the Free Water Protocol treatment for swallowing disorders?

Research shows that the Free Water Protocol can improve fluid intake, swallowing-related quality of life, and overall swallowing function in patients with dysphagia (difficulty swallowing) without increasing the risk of lung complications when patients are carefully selected and guidelines are followed. ^{1 2 3 4 5}

Is the Free Water Protocol generally safe for humans?

The research articles provided do not contain specific safety data on the Free Water Protocol for swallowing disorders. They focus on water ingestion during swimming and waterborne disease surveillance, which are not directly related to the safety of the Free Water Protocol. ^{6 7 8 9 10}

How does the Free Water Protocol treatment differ from other treatments for swallowing disorders?

The Free Water Protocol allows patients with swallowing disorders to drink thin, unthickened water between meals, unlike traditional treatments that restrict them to thickened fluids to prevent aspiration. This approach can improve hydration and quality of life without increasing the risk of lung complications when patients are carefully selected and monitored. ^{1 2 3 4 11}

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Free Water Protocol Experimental Treatment 1 Intervention

Standard care provided for patients with orders for thickened liquids. Additionally, participant will be allowed to have plain, un-thickened water after the following have taken place: 1) Wait 30 minutes after meal or medication administration; 2) Complete oral care according to instructions posted at bedside.

Group II: Control / Standard Care Experimental Treatment 1 Intervention

Standard care provided for patients with orders for thickened liquids.

Who Is Running the Clinical Trial?

Poudre Valley Health System

Lead Sponsor

Trials

17

Recruited

780+

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient suitability for free water protocols in acute stroke and general medicine: a qualitative study of clinician perceptions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of a free water protocol at a long term acute care hospital. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Use of a Modified Frazier Water Protocol in Critical Illness Survivors With Pulmonary Compromise and Dysphagia: A Pilot Study. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Assessing Knowledge, Usage, and Perceptions of the Frazier Free Water Protocol: A Pilot Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Assessment of swimmer behaviors on pool water ingestion. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Surveillance for waterborne disease outbreaks and other health events associated with recreational water --- United States, 2007--2008. [2012]

8. England pubmed.ncbi.nlm.nih.gov

Ingestion of swimming pool water by recreational swimmers. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Reducing risk through 'not cutting corners'. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

[Implementation of the new drinking water regulation section sign 18: monitoring of drinking water systems in houses--water for public use]. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a pilot water protocol project in a rehabilitation setting. [2021]