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Search / Trial NCT06309602

Investigation of a Free Water Protocol

Launched by POUDRE VALLEY HEALTH SYSTEM · Mar 7, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Stroke Trauma

ClinConnect Summary

This clinical trial is looking at a program called the Free Water Protocol (FWP) to see if it can help patients with oropharyngeal dysphagia, which means difficulty swallowing. The main goal is to find out if allowing patients to drink plain water can improve their satisfaction with their care and their overall quality of life, without increasing the risk of serious complications like aspiration pneumonia, which is when food or liquid goes into the lungs instead of the stomach. The study will also evaluate how well patients and their families feel about this new approach and whether it helps keep their mouths healthier.

To participate in the trial, patients must be between the ages of 65 and 74 and have received treatment for a stroke or trauma, and they must currently be on a diet that restricts liquids. They also need to be able to breathe on their own without special equipment. However, people who have certain health conditions, such as severe infections or advanced neurological diseases, or who are not able to participate in oral care, will not be eligible for this study. If you or a loved one meets these criteria and is interested in how allowing access to plain water might improve their care, this trial could provide valuable insights into patient satisfaction and health.

Gender

ALL

Eligibility criteria

  • 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

About Poudre Valley Health System

Poudre Valley Health System (PVHS) is a leading healthcare organization dedicated to advancing clinical research and improving patient outcomes through innovative trials and studies. Located in Fort Collins, Colorado, PVHS encompasses a network of hospitals, outpatient facilities, and specialized care centers, providing comprehensive healthcare services to the community. With a commitment to excellence and patient-centered care, PVHS actively engages in clinical trials across various medical disciplines, collaborating with researchers and industry partners to expand treatment options and enhance the quality of care. Their focus on safety, ethical standards, and rigorous scientific methodologies ensures that participants receive the highest level of care while contributing to the advancement of medical knowledge.

Locations

Loveland, Colorado, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported