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Effect of Oral Hygiene Care on Prevention of Aspiration Pneumonia Among Hospitalized Stroke Patients (OH-STROKE)

A

Addis Ababa University

Status

Completed

Conditions

Stroke
Aspiration Pneumonia

Treatments

Behavioral: Oral hygiene care bundle

Study type

Interventional

Funder types

Other

Identifiers

NCT07382089
TASH_OH_STROKE_AP1

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Oral Hygiene Care Intervention
Experimental group
Description:
Patients admitted after implementation of a structured oral hygiene care protocol delivered by trained nursing staff during hospitalization.
Treatment:
Behavioral: Oral hygiene care bundle
Historical Control Group
No Intervention group
Description:
Patients admitted prior to implementation of the oral hygiene care protocol who received standard oral care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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