Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease

NCT06303999 | Completed

• 1 other identifier: IOE-Small lao
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Small Vessel Diseases

Outcome Measures

Primary Outcomes (1)

• Functional Oral Intake Scale

  During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The FOIS assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.

  day 1 and day 15

Secondary Outcomes (6)

• Body mass index

  day 1 and day 15

• Serum albumin

  day 1 and day 15

• Hemoglobin

  day 1 and day 15

• Pneumonia

  day 1 and day 15

• Activities of daily living

  day 1 and day 15

Study Arms (2)

Nasogastric tube

ACTIVE COMPARATOR

The 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, the tube was secured. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.

Device: Nasogastric tube

Intermittent Oro-esophageal Tube

EXPERIMENTAL

The group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists 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

Device: Intermittent Oro-esophageal Tube

Interventions

Intermittent Oro-esophageal Tube DEVICE

The group was given enteral nutritional support with IOE according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

Intermittent Oro-esophageal Tube

Nasogastric tube DEVICE

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 patient\'s 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. 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. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

Nasogastric tube

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Cerebral Small Vessel Disease;
• Must be able to cooperate with treatment and questionnaire investigation;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhammad: lead

Study Sites (1)

Huimin Hos.

Pengfu, Taiwan

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: January 1, 2023
• Primary Completion: June 2, 2023
• Study Completion: June 15, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)