RECRUITING

Investigation of a Free Water Protocol

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Conditions

Oropharyngeal Dysphagiastroketrauma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigation of a Free Water Protocol

Quick Facts

Study Start:2024-10-22
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06309602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Stroke diagnosis or trauma patients being cared for by Trauma \& Acute Care Surgery (TACS) providers
  2. * Current orders for restricted or thickened liquids
  3. * Ability to control their own airway (i.e. airway adjuncts not needed)
  1. * 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)
  2. * Individuals who refuse oral care, have any decayed teeth or dental disease, or have a documented active oral infection
  3. * Individuals with an advanced progressive neurological condition, active head/neck cancer, or those who are immunosuppressed
  4. * Individuals who are on bed-rest orders
  5. * Individuals who are lethargic or sedated
  6. * Individuals with suspected pre-hospital aspiration event and/or aspiration pneumonitis
  7. * Individuals with a fever of unknown origin
  8. * Individuals with a history of recurrent aspiration pneumonia/pneumonitis
  9. * Individuals whose primary language is one that the questionnaires are not available in a validated format

Contacts and Locations

Study Contact

Emily Main, MS
CONTACT
970-624-4369
emily.main@uchealth.org

Study Locations (Sites)

Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States

Collaborators and Investigators

Sponsor: Poudre Valley Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • stroke
  • trauma

Additional Relevant MeSH Terms

  • Oropharyngeal Dysphagia