Large-Scale Study of Oro-esophageal Feeding Versus Nasogastric Feeding for Swallowing Function and Airway Protection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oro-esophageal Feeding, Nasogastric Feeding, Rehabilitation care.
- Who it may be relevant to
- Registry conditions: Dysphagia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Oro-esophageal Versus Nasogastric Feeding for Stroke Patients With Dysphagia: A Multicenter Randomized Controlled Large-Scale Study
Overview
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
Detailed description
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
The intervention period will last for two weeks, with an additional four-week follow-up observation period. This is a multicenter study to be conducted across multiple hospitals.
Interventions
- Dietary supplement Oro-esophageal Feeding
Medical staff inserts the tube slowly and smoothly into the upper esophagus, verifying the correct insertion depth by referencing the calibration marks on the tube wall. The distance from the incisors to the tube's tip should range from 22 to 25 cm. Following insertion, the distal end of the tube is submerged in a container of water, and the absence of continuous bubbling confirms successful intubation. Feeding is subsequently administered three times daily at a rate of 50 mL per minute, with a - Dietary supplement Nasogastric Feeding
The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient condition and relevant guidelines to reach the energy demand as 20-35 kcal/kg/day and daily protein demand of patients through the determination of 24-h urinary urea for both two groups.The intervention period lasts for a total of two weeks. - Behavioral Rehabilitation care
All patients will receive rehabilitation care according to the standard of care for the trial site hospital. All these interventions are performed in accordance with the Chinese Guidelines for Stroke Rehabilitation and the Chinese Guidelines for Dysphagia Rehabilitation. The intervention period lasts for a total of two weeks.
Primary outcome measures
- Dysphagia Outcome and Severity Scale [Time frame: Day 0 and day15]
Secondary outcome measures (6)
- Time to improvement of one level and of the baseline Dysphagia Outcome and Severity Scale [Time frame: up to 2 weeks]
- Time to oral intake [Time frame: up to 2 weeks]
- Penetration-Aspiration Scale [Time frame: Day 0 and day15]
- Murray Secretion Scale [Time frame: Day 0 and day15]
- Yale Pharyngeal Residual Severity Rating Scale [Time frame: Day 0 and day15]
- Aspiration [Time frame: up to 6 weeks]
Eligibility criteria
Inclusion criteria
- Age>18 years.
- First stroke
- Disease duration less than one month.
- Ischemic stroke.
- Patients who need enteral feeding.
- Dysphagia confirmed by imaging Study.
- Clear consciousness.
- Stable vital signs.
- With informed consent and participants who understand and agree to comply with planned study procedures.
Exclusion criteria
- Dysphagia that might be caused by other diseases or structural abnormalities.
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Contraindications for tube feeding.
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital within two week.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Wang M, Xia C, Lu Y, Zeng H, Liu H, Zhao W, Wang L, Zeng X, Yang Y. Effects of oro-esophageal versus nasogastric feeding on dysphagia for ischemic stroke survivors: study protocol for a randomized controlled trial. Front Nutr. 2026 Apr 29;13:1830508. doi: 10.3389/fnut.2026.1830508. eCollection 2026. PMID 42137858
Identifiers
NCT: NCT07386834 · IOElastreport