Investigation of a Free Water Protocol
ConditionOropharyngeal Dysphagia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoudre Valley Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Free Water Protocol
Other interventionIntake 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
Other interventionStandard 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.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Control / Standard CareOther 1 intervention
Group B: Free Water ProtocolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dysphagia Handicap Index
Quality of life survey
Time frame
Through study completion, an average of 5 days2
Oral Assessment Guide
8-point visual assessment of oral hygiene
Time frame
Through study completion, an average of 5 days3
Qualitative data
Open-ended question to provide a narrative of patient impressions and satisfaction regarding eating and drinking
Time frame
Through study completion, an average of 5 daysSecondary outcomes
1
Adverse events: Aspiration pneumonia/pneumonitis
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)
Time frame
Through study completion, an average of 5 days2
Liquid intake
Oral liquid volume consumed in 24 hours
Time frame
Through study completion, an average of 5 daysSponsors and contacts
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Source ClinicalTrials.gov