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

NCT07059351 | Recruiting

• 1 other identifier: ONZ-2025-0250
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dsyphagia After Stroke

Keywords

Stroke; Deglutition; Dysphagia; Oral care; Swallowing disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of pneumonia

  Diagnosed based on the modified Centers for Disease Control and Prevention criteria (Smith CJ, Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, et al. Diagnosis of stroke-associated pneumonia. Stroke. 2015)

  At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.

Secondary Outcomes (3)

• Oral intake status

  At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.

• Length of hospital stays

  At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.

• In-hospital mortality

  At seven days post-admission and every seven days until discharge from the hospital or up to three months, whichever comes first.

Study Arms (1)

Acute stroke with dysphagia

Acute stroke patients with dysphagia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute stroke patients with dysphagia

You may qualify if:

• Patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke who are diagnosed with oropharyngeal dysphagia.
• Patients over 18 years of age with sufficient cognitive abilities and language skills to understand the swallowing exercises.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Sungkrit Pojmonpiti

CONTACT

+32456398999; sungkrit.pojmonpiti@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 10, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)