Recruiting

Free Water Protocol

Sponsor:

Poudre Valley Health System

Code:

NCT06309602

Conditions

Oropharyngeal Dysphagia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Free Water Protocol

Control / Standard Care

Study Details

Brief 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). 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.

Conditions

Oropharyngeal Dysphagia

Study ID

NCT06309602

Start date

Oct 22, 2024

Status verified date

May, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Control / Standard Care

Standard care provided for patients with orders for thickened liquids.

experimental: Free Water Protocol

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.

Interventions

Free Water Protocol

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 Care

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.

Primary outcome measure

  • Dysphagia Handicap Index [ Time Frame: Through study completion, an average of 5 days ]
  • Oral Assessment Guide [ Time Frame: Through study completion, an average of 5 days ]
  • Qualitative data [ Time Frame: Through study completion, an average of 5 days ]

Central Contacts and Locations

Central contacts

Emily Main, MS

970-624-4369emily.main@uchealth.org

Locations

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Emily Main, MS

970-624-4369Emily.Main@uchealth.org

More Information

Sponsor

Poudre Valley Health System

Last update posted

Jun 5, 2025

Last verified

May, 2025

Keywords

  • stroke
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Poudre Valley Health System on 2025-06-05.