Clinical trial NCT06309602: Investigation of a Free Water Protocol
Official title: Investigation of a Free Water Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharyngeal Dysphagia
Keywords: stroke
trauma
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Dysphagia Handicap Index
timeFrame: Through study completion, an average of 5 days
measure: Oral Assessment Guide
timeFrame: Through study completion, an average of 5 days
measure: Qualitative data
timeFrame: Through study completion, an average of 5 days
Secondary outcomes:
measure: Adverse events: Aspiration pneumonia/pneumonitis
timeFrame: Through study completion, an average of 5 days
measure: Liquid intake
timeFrame: Through study completion, an average of 5 days
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
References: