Effects of Gastrostomy and Oral Tube Feeding on Patients With Dysphagia After Stroke

Muhammad

Status: Not yet enrolling

Conditions: Stroke, Ischemic

Treatments: Dietary Supplement: Gastrostomy; Behavioral: routine rehabilitation therapy; Dietary Supplement: Oral tube feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06818513

PEG in stroke dysphagia

Details and patient eligibility

About

The goal of this clinical trial is to compare the differences in swallowing function, quality of life and nutritional status between ischemic stroke patients with dysphagia using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in swallowing function, quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

Full description

This study will last 15 days for each patient. The goal of this clinical trial is to compare the differences in swallowing function, quality of life and nutritional status between ischemic stroke patients with dysphagia using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in swallowing function, quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>18 years.
• Meeting the diagnostic criteria for ischemic stroke .
• Dysphagia confirmed by Videofluoroscopic Swallowing Study.
• Clear consciousness.
• No history of prior stroke.
• Stable vital signs.

Exclusion criteria

• Use of tracheostomy tubes.
• 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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150 participants in 2 patient groups

Oral tube group+routine rehabilitation therapy

Experimental group

Description:

All patients are provided with routine rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. The oral tube group will be given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups.

Treatment:

Dietary Supplement: Oral tube feeding

Behavioral: routine rehabilitation therapy

Gastrostomy group+routine rehabilitation therapy

Active Comparator group

Description:

All patients were provided with routine rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. The Gastrostomy group will be given enteral nutritional support with Gastrostomy. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups

Treatment:

Behavioral: routine rehabilitation therapy

Dietary Supplement: Gastrostomy