Effect of Oral Hygiene Care on Prevention of Aspiration Pneumonia Among Hospitalized Stroke Patients

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.

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Key information

Conditions

Stroke Aspiration Pneumonia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cross Infection Deglutition Disorders Digestive System Diseases Disease Attributes Esophageal Diseases Gastrointestinal Diseases Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tikur Anbessa Specialized Hospital, Addis Ababa University

Addis Ababa, 26901, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oral hygiene care bundle

Behavioral

A structured oral hygiene care protocol including regular oral cavity cleaning and toothbrushing during hospitalization.

Other names: Oral hygiene

Primary outcomes

Incidence of Aspiration Pneumonia

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Addis Ababa University

Other

Registry information

Official study title

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

Acronym: OH-STROKE

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Feb 2, 2026
Registry last updated: Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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