Effects of Oro-esophageal Tubes on Swallowing Function in Ischemic Stroke Survivors

Effects of Oro-esophageal Versus Nasogastric Tubes on Swallowing Function in Ischemic Stroke Survivors: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Behavioral: standard rehabilitation therapy; Dietary supplement: Oro-esophageal Feeding; Dietary supplement: Nasogastric Feeding

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age>18 years.
• Meeting the diagnostic criteria for ischemic stroke.
• Patients who need enteral feeding.
• Dysphagia confirmed by Videofluoroscopic Swallowing Study.
• Clear consciousness.
• Stable vital signs.

Exclusion Criteria:

• Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
• Pregnant or nursing females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oro-esophageal Feeding; 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; 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.; Dietary supplement: Oro-esophageal Feeding; 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.
Active Comparator: Nasogastric 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; 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.; Dietary supplement: Nasogastric 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Day 0 and day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 and day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Both patients and staff are permitted to report any adverse events, which will be documented, categorized and statistically analyzed by the researchers.	From day 0 to the end of the study (day 15)

Collaborators and Investigators

• Sponsor: Zeng Changhao

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: IOEvsNGonStroke

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No