Viewing Study NCT06309602



Ignite Creation Date: 2024-05-06 @ 8:14 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06309602
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-13
First Post: 2023-11-02

Brief Title: Investigation of a Free Water Protocol
Sponsor: Poudre Valley Health System
Organization: Poudre Valley Health System

Study Overview

Official Title: Investigation of a Free Water Protocol
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 pneumoniapneumonitis 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 familycaregivers 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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None