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

NCT07302594 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-12-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Zeng Changhao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2026-12-31
Completion
2026-12-31

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Entities

Diseases

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 NCT07302594 on ClinicalTrials.gov