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临床试验/NCT07382089
NCT07382089已完成不适用

Effect of Oral Hygiene Care on Aspiration Pneumonia Among Hospitalized Stroke Patients: A Quasi-Experimental Study With Historical Controls

Addis Ababa University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Incidence of Aspiration Pneumonia

研究概览

简要总结

Aspiration pneumonia is a common and serious complication among hospitalized patients with stroke. Poor oral hygiene can increase the risk of aspiration pneumonia by promoting bacterial colonization of the oral cavity. This study evaluated whether implementing a structured oral hygiene care protocol during hospitalization could reduce the incidence of aspiration pneumonia among stroke patients. In this non-randomized, quasi-experimental study, patients admitted after implementation of an oral hygiene care protocol received structured oral care delivered by trained nursing staff, while patients admitted prior to implementation served as historical controls and received standard care. The primary outcome was the occurrence of aspiration pneumonia during hospitalization. The findings of this study aim to inform simple, low-cost preventive strategies that may improve clinical outcomes for hospitalized stroke patients, particularly in resource-limited settings.

详细描述

This study is a quasi-experimental, non-randomized interventional study with parallel assignment using historical controls, conducted among hospitalized adult stroke patients at a tertiary care hospital. The study evaluated the effect of implementing a structured oral hygiene care protocol on the incidence of aspiration pneumonia during hospitalization. Patients admitted prior to implementation of the oral hygiene care protocol constituted the historical control group and received standard oral care practices. Patients admitted after implementation received a structured oral hygiene care bundle delivered by trained nursing staff as part of routine inpatient care. The oral hygiene intervention included regular oral cavity cleaning and toothbrushing according to a predefined protocol. The primary outcome was aspiration pneumonia diagnosed during hospitalization based on clinical features and radiologic findings. Secondary outcomes included in-hospital clinical outcomes as defined in the study protocol. Ethical approval was obtained from the Institutional Review Board of Tikur Anbessa Specialized Hospital, and informed consent was obtained from participants or their legal representatives, with appropriate waivers applied for retrospective data where applicable. This study was designed to assess the feasibility and effectiveness of a low-cost, preventive intervention that may reduce aspiration-related complications among stroke patients, particularly in resource-constrained healthcare settings.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Adults aged 18 years or older
  • Hospitalized patients with a confirmed diagnosis of acute stroke (ischemic or hemorrhagic)
  • Admission to the stroke unit or medical ward during the study period
  • Ability to receive oral care as part of routine nursing care

排除标准

  • Patients with active pneumonia at the time of hospital admission
  • Patients who were intubated or mechanically ventilated at admission
  • Patients with facial or oral conditions precluding oral hygiene care
  • Patients discharged or deceased within 24 hours of admission

研究组 & 干预措施

Oral Hygiene Care Intervention

Experimental

Patients admitted after implementation of a structured oral hygiene care protocol delivered by trained nursing staff during hospitalization.

干预措施: Oral hygiene care bundle (Behavioral)

Historical Control Group

No Intervention

Patients admitted prior to implementation of the oral hygiene care protocol who received standard oral care.

结局指标

主要结局

Incidence of Aspiration Pneumonia

时间窗: From baseline (hospital admission) through hospital discharge, up to 21 days

Aspiration pneumonia diagnosed during hospital admission, based on clinical features (fever, cough, purulent sputum), radiologic evidence of new pulmonary infiltrates, and treating physician documentation.

次要结局

未报告次要终点

研究者

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

Surafel Tilahun Maru

Investigator

Addis Ababa University

研究点 (1)

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