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

Zeng Changhao

Status: Begins enrollment this month

Conditions: Dysphagia

Treatments: Behavioral: Rehabilitation care; Dietary Supplement: Oro-esophageal Feeding; Dietary Supplement: Nasogastric Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT07386834

IOElastreport

Details and patient eligibility

About

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.

Full 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.

Enrollment: 422 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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 one week.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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422 participants in 2 patient groups

Oro-esophageal Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Oro-esophageal Feeding

Behavioral: Rehabilitation care

Nasogastric Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nasogastric Feeding

Behavioral: Rehabilitation care