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

Zeng Changhao

Status: Not yet enrolling

Conditions: Dysphagia

Treatments: Dietary Supplement: Oro-esophageal Feeding; Behavioral: standard rehabilitation therapy; Dietary Supplement: Nasogastric Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT07302594

IOEvsNGonStroke

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

Oro-esophageal Feeding

Experimental group

Description:

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.

Treatment:

Behavioral: standard rehabilitation therapy

Dietary Supplement: Oro-esophageal Feeding

Nasogastric Feeding

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nasogastric Feeding

Behavioral: standard rehabilitation therapy