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A Prospective, Randomized Clinical Trial of Intermittent Oroesophageal Tube Feeding (IOE) in Patients with Dysphagia after Acute Ischemic Stroke: The RIOETF Trial

A Prospective, Randomized Clinical Trial of Intermittent Oroesophageal Tube Feeding (IOE) in Patients with Dysphagia after Acute Ischemic Stroke: The RIOETF Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104141
Enrollment
Unknown
Registered
2025-06-11
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Stroke

Interventions

Experimental group:Intermittent oral feeding to the esophageal feeding tube
Control Group:Nasogastric Tube (NGT)

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years; 2.Time from stroke onset to randomization = Grade 3; 5.Requirement for enteral nutrition support; 6.Written informed consent provided by the patient or legal guardian.

Exclusion criteria

Exclusion criteria: 1.Intracranial hemorrhage confirmed by CT/MRI; 2.History of prior stroke with residual dysphagia (Grade >=3); 3.Pharyngeal or esophageal tumors; 4.Obstruction of the mid-to-lower esophagus; 5.Contraindications to enteral nutrition (e.g., intestinal ischemia, perforation); 6.Thoracic aortic aneurysm; 7.Acute respiratory distress syndrome (ARDS); 8.History of gastrointestinal perforation; 9.Anatomical deformities of the pharynx or cervical region; 10.Severe cognitive impairment precluding cooperation; 11.Coagulopathy (INR >1.5 or platelet count <50×10?/L); 12.Nasal obstruction preventing nasogastric tube placement; 13.History of corrosive substance ingestion; 14.Active gastrointestinal bleeding; 15.Concurrent participation in other interventional trials; 16.Pre-existing gastrostomy or nasogastric tube prior to stroke onset; 17.Life expectancy <6 months due to terminal illness; 18.Anticipated inability to complete follow-up.

Design outcomes

Primary

MeasureTime frame
Body Mass Index (BMI);

Secondary

MeasureTime frame
Nutritional Status;EuroQol Five-Dimensional Questionnaire (EQ-5D) Score;National Institutes of Health Stroke Scale (NIHSS) Score;Swallowing Function;Incidence of Stroke-Associated Pneumonia (SAP);Modified Rankin Scale (mRS) Score;

Countries

China

Contacts

Public ContactLuo Min

Mianyang Central Hospital

410244386@qq.com+86 182 8198 9985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026