Investigation of a Free Water Protocol

March 7, 2024 updated by: Emily Main, MS, CCC-SLP, Poudre Valley Health System
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
        • Contact:
        • Sub-Investigator:
          • Brian Daily, MD
        • Sub-Investigator:
          • Cordelie Witt, MD
        • Sub-Investigator:
          • Lucie Uncapher, MD
        • Sub-Investigator:
          • Brandon Petrun, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control / Standard Care
Standard care provided for patients with orders for thickened liquids.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysphagia Handicap Index
Time Frame: Through study completion, an average of 5 days
Quality of life survey
Through study completion, an average of 5 days
Oral Assessment Guide
Time Frame: Through study completion, an average of 5 days
8-point visual assessment of oral hygiene
Through study completion, an average of 5 days
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
Through study completion, an average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events: Aspiration pneumonia/pneumonitis
Time Frame: Through study completion, an average of 5 days
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)
Through study completion, an average of 5 days
Liquid intake
Time Frame: Through study completion, an average of 5 days
Oral liquid volume consumed in 24 hours
Through study completion, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0465

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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