Effects of oro-esophageal versus nasogastric feeding on dysphagia for ischemic stroke survivors: study protocol for a randomized controlled trial.

BACKGROUND

Enteral nutrition is commonly practiced for ischemic stroke survivors with dysphagia. In Eastern Asia, nasogastric and oro-esophageal tubes are the mainstream options. However, there is a lack of rigorous clinical evidence on the effects of these two feeding methods on swallowing-related rehabilitation outcomes and clinical relevance.

OBJECTIVES

This study is clinically oriented and aims to assess the effect of nasogastric versus oro-esophageal tube feeding on the degree and speed of dysphagia improvement, and aspiration symptoms.

METHODS

This multicenter randomized controlled trial will include 422 ischemic stroke patients with dysphagia who require tube feeding. Stratified randomization will be performed to assign participants 1:1 to the oro-esophageal or nasogastric groups. All participants will receive 15-days routine rehabilitation care and nasogastric or oro-esophageal feeding, according to their group assignment.

OUTCOMES: The primary outcome is the dysphagia severity assessed using the Dysphagia Outcome and Severity Scale (DOSS). The secondary outcomes include time to improvement of one level from the baseline DOSS, time to oral intake, accumulation of secretions assessed using the Murray Secretion Scale, pharyngeal residue after swallowing assessed using the Yale Pharyngeal Residual Severity Rating Scale, and airway protection assessed using the Penetration-Aspiration Scale. Aspiration symptoms will be monitored for 6 weeks.

DISCUSSION: This study aims to provide evidence-based support for the comprehensive effects of tube feeding on swallowing-related rehabilitation outcomes.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT07386834.