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

NCT07386834 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2026-03-11

No results posted yet for this study

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

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

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.

Sponsors & Collaborators

  • Zeng Changhao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-03-31
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386834 on ClinicalTrials.gov