Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident

Copka Sonpashan

Status: Not yet enrolling

Conditions: Stroke

Treatments: Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06328907

IOE Social Condition

Details and patient eligibility

About

The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the Social Condition and experience of the two groups.

Full description

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Social Condition and Experience of two groups.

Enrollment: 80 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 video fluoroscopic 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, 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding

Experimental group

Description:

Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy. The group is 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:

Device: Intermittent Oro-esophageal Tube Feeding

Behavioral: comprehensive rehabilitation therapy

comprehensive rehabilitation therapy+Nasogastric Tube Feeding

Active Comparator group

Description:

Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy.Besides, this group is given enteral nutritional support with Nasogastric Tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.

Treatment:

Device: Nasogastric Tube Feeding

Behavioral: comprehensive rehabilitation therapy