Oropharyngeal DysphagiaNCT06309602
Investigation of a Free Water Protocol
A study testing Free Water Protocol in people with Oropharyngeal Dysphagia, run by Poudre Valley Health System at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Free Water Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Emily Main, MS, CCC-SLP, 970-624-4369, emily.main@uchealth.org
Brian Daily, MD
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Emily Main, MS, 970-624-4369, Emily.Main@uchealth.org
About this study
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.
Read the detailed description
Individuals who have difficulty swallowing thin liquids are commonly restricted from ingesting plain water and prescribed a thickened liquid only diet to prevent choking hazards and aspiration pneumonia. These thickened liquids are intended to reduce aspiration of oral secretions carrying respiratory pathogens, the primary cause of aspiration pneumonia. This restriction from plain water (also known as thin water) can result in lowered patient satisfaction in addition to dissatisfaction with the texture and taste of thickened liquids. However, prior research from inpatient rehabilitation settings has demonstrated that plain water can be given to patients who otherwise require thickened liquids to prevent aspiration pneumonia. If patients prescribed a thickened liquid diet are allowed access to plain water, then hydration status may improve along with increased patient satisfaction.
This Free Water Protocol (FWP) differs from a thickened-liquids-only protocol in three ways: 1) allowing individuals access to plain, un-thickened water; 2) purposefully providing oral care prior to access of plain water; and 3) not allowing plain water until 30 minutes after meal completion and oral care has been completed with the intent to reduce the risk of pulmonary complications. Although many institutions have adapted and implemented an FWP, only 10 studies have measured pulmonary complications of an FWP. Among those, other outcomes are reported inconsistently with varying methodologies (e.g., fluid intake, hydration status, occurrences of urinary tract infection, satisfaction measures). More research is needed to demonstrate the benefits of allowing free water over the risk of potential pulmonary complications, especially in an acute care setting.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Free Water Protocol, Control / Standard Care
- Keywords
- stroke, trauma
- Medical subject headings
- Deglutition Disorders, Stroke, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Water ProtocolOther
Intake of plain, un-thickened water is allowed even when a patient has orders for thickened liquids. Risks of pulmonary complications are decreased with use of a strict oral care regimen and timed intake of water related to meals. Patient satisfaction and comfort is increased with ingestion of plain water.
Control / Standard CareOther
Standard care will be given to patients with orders for thickened liquids. This will include oral care twice a day and implementation of swallowing strategies and precautions as prescribed by the treating speech-language pathologist. Only fluids thickened to the recommended viscosity will be available to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Control / Standard Care | Other | Standard care provided for patients with orders for thickened liquids. Receives: Other: Control / Standard Care |
| Free Water Protocol | Experimental | 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. Receives: Other: Free Water Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Handicap Index
Quality of life survey
Measured: Through study completion, an average of 5 days
Oral Assessment Guide
8-point visual assessment of oral hygiene
Measured: Through study completion, an average of 5 days
Qualitative data
Open-ended question to provide a narrative of patient impressions and satisfaction regarding eating and drinking
Measured: Through study completion, an average of 5 days
Secondary outcomes (2)
Adverse events: Aspiration pneumonia/pneumonitis
Aspiration pneumonia/pneumonitis diagnosed by the treating provider or by the following criteria: The presence of a new or evolving infiltrate on chest x-ray while meeting the following criteria: temperature greater than 38.2˚C, leukocytosis greater than 12,000 cells/mm3, and presence of purulent sputum or endotracheal aspirate)
Measured: Through study completion, an average of 5 days
Liquid intake
Oral liquid volume consumed in 24 hours
Measured: Through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start22 Oct 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Main, MS, CCC-SLP, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309602
- Sponsor's protocol ID
- 22-0465
- Status last verified
- May 2025
- First submitted
- 2 Nov 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Free Water Protocol
- ClinicalTrials.gov ID
- NCT06309602
- Acronym / sponsor ID
- 22-0465
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- stroke, trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals who have difficulty swallowing thin liquids are commonly restricted from ingesting plain water and prescribed a thickened liquid only diet to prevent choking hazards and aspiration pneumonia. These thickened liquids are intended to reduce aspiration of oral secretions carrying respiratory pathogens, the primary cause of aspiration pneumonia. This restriction from plain water (also known as thin water) can result in lowered patient satisfaction in addition to dissatisfaction with the texture and taste of thickened liquids. However, prior research from inpatient rehabilitation settings has demonstrated that plain water can be given to patients who otherwise require thickened liquids to prevent aspiration pneumonia. If patients prescribed a thickened liquid diet are allowed access to plain water, then hydration status may improve along with increased patient satisfaction.
This Free Water Protocol (FWP) differs from a thickened-liquids-only protocol in three ways: 1) allowing individuals access to plain, un-thickened water; 2) purposefully providing oral care prior to access of plain water; and 3) not allowing plain water until 30 minutes after meal completion and oral care has been completed with the intent to reduce the risk of pulmonary complications. Although many institutions have adapted and implemented an FWP, only 10 studies have measured pulmonary complications of an FWP. Among those, other outcomes are reported inconsistently with varying methodologies (e.g., fluid intake, hydration status, occurrences of urinary tract infection, satisfaction measures). More research is needed to demonstrate the benefits of allowing free water over the risk of potential pulmonary complications, especially in an acute care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control / Standard Care | Other | Other: Control / Standard CareStandard care provided for patients with orders for thickened liquids. |
| Free Water Protocol | Experimental | Other: Free Water ProtocolStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Water ProtocolIntake of plain, un-thickened water is allowed even when a patient has orders for thickened liquids. Risks of pulmonary complications are decreased with use of a strict oral care regimen and timed intake of water related to meals. Patient satisfaction and comfort is increased with ingestion of plain water. | Other | Free Water Protocol |
| Control / Standard CareStandard care will be given to patients with orders for thickened liquids. This will include oral care twice a day and implementation of swallowing strategies and precautions as prescribed by the treating speech-language pathologist. Only fluids thickened to the recommended viscosity will be available to the patient. | Other | Control / Standard Care |
Primary outcome
Dysphagia Handicap Index
Time frame: Through study completion, an average of 5 days
Quality of life survey
Oral Assessment Guide
Time frame: Through study completion, an average of 5 days
8-point visual assessment of oral hygiene
Qualitative data
Time frame: Through study completion, an average of 5 days
Open-ended question to provide a narrative of patient impressions and satisfaction regarding eating and drinking
2 secondary outcomes
Adverse events: Aspiration pneumonia/pneumonitis
Time frame: Through study completion, an average of 5 days
Liquid intake
Time frame: Through study completion, an average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Water Protocol in people with Oropharyngeal Dysphagia, run by Poudre Valley Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Main, MS (970-624-4369, emily.main@uchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Handicap Index (time frame: Through study completion, an average of 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.