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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07382089
Acronym
OH-STROKE
Enrollment
90
Registered
2026-02-02
Start date
2023-05-01
Completion date
2024-01-30
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonia, Stroke

Keywords

Oral hygiene, Aspiration pneumonia prevention, Stroke patients, Dysphagia, Hospital-acquired pneumonia

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALOral hygiene care bundle

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

Sponsors

Addis Ababa University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

This is a non-randomized, parallel assignment study using historical controls. Patients admitted after implementation of the oral hygiene care protocol received the intervention, while patients admitted prior to implementation served as the control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Aspiration PneumoniaFrom baseline (hospital admission) through hospital discharge, up to 21 daysAspiration pneumonia diagnosed during hospital admission, based on clinical features (fever, cough, purulent sputum), radiologic evidence of new pulmonary infiltrates, and treating physician documentation.

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026