Investigation of a Free Water Protocol for Swallowing Difficulties

This study is investigating a new approach called the Free Water Protocol (FWP) for people who have difficulty swallowing (oropharyngeal dysphagia) and are usually restricted to thickened liquids. The FWP allows you to drink plain, un-thickened water, along with strict oral care and timed water intake around meals. This is being compared to standard care, which involves thickened liquids, regular oral care, and swallowing strategies. The researchers want to see if the FWP improves your satisfaction and quality of life, without increasing the risk of lung complications like aspiration pneumonia. They also want to understand how it affects oral hygiene. You might be able to join if you've had a stroke or trauma, have orders for thickened liquids, and can control your own airway. The study is planning to enroll 136 participants, but its current status is unclear.

Study design
This is an interventional study comparing the Free Water Protocol to standard care. It plans to enroll 136 participants.
What's involved
Your participation would involve assessments of your swallowing handicap and oral health, as well as qualitative data collection, over an average of 5 days.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed through study completion, which is an average of 5 days.

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NCT06309602

Investigation of a Free Water Protocol

Recruiting
NAAges 18+InterventionalTreatment
Poudre Valley Health System
~136 participants
Updated 2025-06-05 on ClinicalTrials.gov
What's tested:Free Water ProtocolControl / Standard Care

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dysphagia Handicap Index
Measured over Through study completion, an average of 5 days
+2 more outcomes measured
Oropharyngeal Dysphagia
2 sites across 1 states
Colorado2

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Eligibility criteria

Inclusion

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)

Exclusion

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
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 one that the questionnaires are not available in a validated format
  • Dysphagia Handicap IndexThrough study completion, an average of 5 days

    Quality of life survey

  • Oral Assessment GuideThrough study completion, an average of 5 days

    8-point visual assessment of oral hygiene

  • Qualitative dataThrough study completion, an average of 5 days

    Open-ended question to provide a narrative of patient impressions and satisfaction regarding eating and drinking