Clinical Trial

Oral Status as Predictors of Stroke-Associated Pneumonia and Swallowing Recovery in Patients With Post-Stroke Dysphagia

Recruiting
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Summary
Post-stroke dysphagia (PSD) is a common condition that significantly impacts recovery and increases the risk of complications such as pneumonia, malnutrition, and prolonged hospital stays. Early identification and management are essential, as emphasized in several international clinical guidelines. However, predicting which patients will develop stroke-associated pneumonia (SAP) or experience delayed swallowing recovery remains a challenge. Recent evidence suggests that oral health status-including hygiene, tongue strength, and dental support-may play a key role in these outcomes. Assessing oral health could therefore aid in identifying high-risk patients and improving rehabilitation strategies. Study Design and Setting A cohort study was designed with prospective data collection, conducted in parallel with a randomized controlled trial (RCT) at the stroke unit of Ghent University Hospital, Ghent, Belgium (ONZ-2024-0245). Data collection is expected to occur over two years, from 2025 to 2027. The RCT is a one-day experimental study investigating the immediate effects of oral hygiene care on swallowing and masticatory functions. The interventions performed in this clinical study involve routine oral care procedures and are not expected to influence the outcomes of the cohort study. Participants Participants will be recruited from all consecutive patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke and a diagnosis of oropharyngeal dysphagia. For the diagnosis of oropharyngeal dysphagia, all patients will be restricted from oral intake upon arrival until a stroke nurse completes a step-by-step standardized protocol to screen for swallowing disorders.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-07.
Status change: Not Yet Recruiting → Recruiting 2025-07-14
Trial Details
NCT Number NCT07059351
Lead Sponsor University Hospital, Ghent
Conditions Dsyphagia After Stroke
Enrollment 260 participants
Start Date 2025-07-02
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-17