An interventional study of standard rehabilitation therapy and Oro-esophageal Feeding in Dysphagia, sponsored by Zeng Changhao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Zeng Changhao · Not applicable, Interventional, and Supportive care
This is an open-label randomized controlled trial. The participants are ischemic stroke patients requiring enteral nutrition. The study is conducted in the Department of Rehabilitation Medicine and Department of Neurology.
The purpose of this study is to explore the effects of Intermittent Oro-esophageal Tube Feeding versus Nasogastric Tube Feeding on participants' swallowing function and airway protection.
Specifically, the study aims to answer the following two key questions:
Is there any difference between the two feeding methods in terms of their effects on swallowing function? Are the safety profiles of the two feeding methods consistent? Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
Participants will be divided into two groups randomly, with different nutritional support respectively.
This is a two-arm open-label randomized controlled trial. The participants are dysphagic ischemic stroke patients requiring enteral nutrition. The study is conducted in the Department of Rehabilitation Medicine and Department of Neurology.
The purpose of this study is to explore the effects of Intermittent Oro-esophageal Tube Feeding versus Nasogastric Tube Feeding on participants' swallowing function and airway protection.
Specifically, the study aims to answer the following two key questions:
Is there any difference between the two feeding methods in terms of their effects on swallowing function? Are the safety profiles of the two feeding methods consistent? Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 156 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Zeng Changhao is the lead sponsor of 59 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Patients will receive basic rehabilitation therapy in accordance with relevant guidelines. In addition, patients in this group will receive oro-esophageal tube feeding, with 3-6 feeding sessions per day. The feeding tube is inserted before each meal and removed immediately after feeding. Both groups of participants are administered the same nutritional standards.
Behavioral: standard rehabilitation therapy · Dietary Supplement: Oro-esophageal Feeding
Patients will receive basic rehabilitation therapy in accordance with relevant guidelines. In addition, patients in this group will receive nasogastric tube feeding, with an interval of at least 2 hours between each feeding session. The feeding tube remains indwelling after insertion and is not removed. Both groups of participants are administered the same nutritional standards.
Behavioral: standard rehabilitation therapy · Dietary Supplement: Nasogastric Feeding
Patients will receive corresponding interventions for secondary prevention in accordance with relevant guidelines and the conditions of each participating center, as well as common rehabilitation therapies. These interventions will be consistent between the two groups.
Before each feeding, inside and outside of the tube is cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube is inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation is checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding is to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.
Within 4 hours after admission, the placement of the feeding tube is conducted by professional medical staffs and after intubation, the tube is secured to the patient cheek. The feeding is conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.
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 day 15
Dysphagia Outcome and Severity Scale
The Dysphagia Outcome and Severity Scale is a key tool for grading the severity of swallowing disorders and evaluating functional outcomes in patients. It has 7 grades, ranging from severe swallowing impairment to normal swallowing function. Higher grades = better function: Grade 1 means no safe oral intake at all; Grade 7 represents normal swallowing with no restrictions or compensatory strategies.
Time frame: Day 0 and day 15
Functional Oral Intake Scale
The Functional Oral Intake Scale is a key tool for grading oral intake ability in patients with swallowing disorders. It has 7 grades, ranging from complete non-oral intake to full oral intake with no restrictions. Higher grades = better function: Grade 1 means total reliance on tube feeding; Grade 7 represents unrestricted oral intake of all consistencies.
Time frame: Day 0 and day 15
Adverse Events
Both patients and staff are permitted to report any adverse events, which will be documented, categorized and statistically analyzed by the researchers.
Time frame: From day 0 to the end of the study (day 15)
No study locations are listed for this record.
Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 12 months is below that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Zeng Changhao