Large-Scale Study of Oro-esophageal Feeding Versus Nasogastric Feeding for Swallowing Function and Airway Protection

NCT07386834 | Not Yet Recruiting DMC

• 1 other identifier: IOElastreport
• Study Type: interventional
• Target: 422
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Dysphagia Outcome and Severity Scale

  The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.

  Day 0 and day15

Secondary Outcomes (6)

• Time to improvement of one level and of the baseline Dysphagia Outcome and Severity Scale

  up to 2 weeks

• Time to oral intake

  up to 2 weeks

• Penetration-Aspiration Scale

  Day 0 and day15

• Murray Secretion Scale

  Day 0 and day15

• Yale Pharyngeal Residual Severity Rating Scale

  Day 0 and day15

Study Arms (2)

Oro-esophageal Group

EXPERIMENTAL

Participants will receive oro-esophageal feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized.

Dietary Supplement: Oro-esophageal Feeding; Behavioral: Rehabilitation care

Nasogastric Group

ACTIVE COMPARATOR

Participants will receive Nasogastric feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized.

Dietary Supplement: Nasogastric Feeding; Behavioral: Rehabilitation care

Interventions

Oro-esophageal Feeding DIETARY_SUPPLEMENT

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 volume of 400 to 600 mL per feeding. The intervention period lasts for a total of two weeks.

Oro-esophageal Group

Nasogastric Feeding DIETARY_SUPPLEMENT

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.

Nasogastric Group

Rehabilitation care BEHAVIORAL

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.

Nasogastric Group; Oro-esophageal Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Site Principle Manager

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03