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临床试验/NCT06309602
NCT06309602招募中不适用

Investigation of a Free Water Protocol

Poudre Valley Health System3 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
136
试验地点
3
主要终点
Dysphagia Handicap Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Control / Standard Care

Other

Standard care provided for patients with orders for thickened liquids.

干预措施: Control / Standard Care (Other)

Free Water Protocol

Experimental

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.

干预措施: Free Water Protocol (Other)

结局指标

主要结局

Dysphagia Handicap Index

时间窗: Through study completion, an average of 5 days

Quality of life survey

Oral Assessment Guide

时间窗: Through study completion, an average of 5 days

8-point visual assessment of oral hygiene

Qualitative data

时间窗: Through study completion, an average of 5 days

Open-ended question to provide a narrative of patient impressions and satisfaction regarding eating and drinking

次要结局

  • Liquid intake(Through study completion, an average of 5 days)
  • Adverse events: Aspiration pneumonia/pneumonitis(Through study completion, an average of 5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Main, MS, CCC-SLP

Principal Investigator

Poudre Valley Health System

研究点 (3)

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