Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease

NCT ID: NCT06303999

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-06-15

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.

Detailed 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.

Conditions

Cerebral Small Vessel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nasogastric tube

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.

Group Type: ACTIVE_COMPARATOR

Nasogastric tube

Intervention Type: 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.

Intermittent Oro-esophageal Tube

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

Group Type: EXPERIMENTAL

Intermittent Oro-esophageal Tube

Intervention Type: 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.

Interventions

Intermittent Oro-esophageal Tube

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.

Intervention Type: DEVICE

Nasogastric tube

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad

OTHER

Sponsor Role: lead

Responsible Party

Muhammad

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Luis, Master

Role: STUDY_CHAIR

Site Coordinator of United Medical Group

Locations

Huimin Hos.

Pengfu, , Taiwan

Countries

Taiwan

Other Identifiers

IOE-Small lao

Identifier Type: -

Identifier Source: org_study_id