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Not yet recruitingNCT07386834IOEfinalUpdated Mar 11, 2026

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

An interventional study of Oro-esophageal Feeding and Nasogastric Feeding in Dysphagia, sponsored by Zeng Changhao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Zeng Changhao · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
422
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

Read the 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.

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Conditions studied

  • Dysphagia

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
422 participants (estimated)

Study arms

  • Experimental
    Oro-esophageal Group

    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

  • Active comparator
    Nasogastric Group

    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

  • Dietary supplementOro-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 supplementNasogastric 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.

  • BehavioralRehabilitation 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.

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What researchers measure

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.

    Time frame: Day 0 and day15

Secondary outcomes

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

    The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. The investigators will record the time required for participants to achieve a one-grade improvement from the baseline Dysphagia Outcome and Severity Scale.

    Time frame: up to 2 weeks

  2. Time to oral intake

    The time to recovery is the first day, during the two weeks of the intervention period, on which a participant meets level 3, 4, 5, 6, or 7 on the 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.

    Time frame: up to 2 weeks

  3. Penetration-Aspiration Scale

    The Penetration-Aspiration Scale is for assessing airway protection. It has 8 grades, grouped into 3 categories: no penetration/aspiration, penetration, aspiration. Lower grades = better function: Grade 1 is optimal (no airway entry); Grade 8 is most severe (food enters airway below vocal cords with no clearing effort).

    Time frame: Day 0 and day15

  4. Murray Secretion Scale

    The Murray Secretion Scale is used to evaluate the accumulation of secretions, in which grade 0 meant no obvious accumulation, and grade 3 meant secretions in the laryngeal vestibule. The Murray Secretion Scale has 4 grades. The higher grade indicates more severe accumulation of secretions.

    Time frame: Day 0 and day15

  5. Yale Pharyngeal Residual Severity Rating Scale

    The Yale Pharyngeal Residual Severity Rating Scale is used to evaluate pharyngeal residue after swallowing. The score could range between 1 and 5, with higher scores indicating worse situations.

    Time frame: Day 0 and day15

  6. Aspiration

    Aspiration is based on self-reporting, caregiver monitoring, or the diagnosis of aspiration pneumonia, defined as the coughing and discomfort caused by food or water entering the airway for various reasons. The numbers of aspiration will be recorded.

    Time frame: up to 6 weeks

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 42137858 ↗
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Registry details

Key details

Study ID
NCT07386834
Lead sponsor
Zeng Changhao
Responsible party
Zeng Changhao (Site Principle Manager, People's Hospital of Zhengzhou University) — Sponsor-investigator
First posted
Feb 4, 2026
Start date
Mar 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Mar 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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