Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients

Zeng Changhao

Status: Enrolling

Conditions: Dysphagia; Cerebral Small Vessel Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06265857

IOE-naoxiaoxueguan

Details and patient eligibility

About

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Full description

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia.

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Enrollment: 88 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of CSVD, confirmed by MRI;
• Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
• Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
• Age between 40 and 70 years;
• Enteral nutrition support was required and feasible.
• No history of prior stroke.

Exclusion criteria

• Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
• Complicated with severe liver and kidney failure, tumors, or hematological disorders;
• Simultaneously 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: Double Blind

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88 participants in 2 patient groups

The control group

Active Comparator group

Description:

Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy. Besides, the control group was 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.

Treatment:

Device: Nasogastric Tube Feeding

Behavioral: comprehensive rehabilitation therapy

The observation group

Experimental group

Description:

Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy. Besides, the observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding according to the relevant guidelines.

Treatment:

Device: Intermittent Oro-esophageal Tube Feeding

Behavioral: comprehensive rehabilitation therapy