Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients

NCT06328842 | Not Yet Recruiting

• 1 other identifier: IOE Cerebral Small Vessel
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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)

• Video Fluoroscopic Swallowing Study

  Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).

  day 1 and day 15

Secondary Outcomes (5)

• Functional Oral Intake Scale

  day 1 and day 15

• Body mass index

  day 1 and day 15

• Pneumonia

  day 1 and day 15

• Activities of daily living

  day 1 and day 15

• World Health Organization Quality of Life Assessment Instrument Brief Version

  day 1 and day 15

Study Arms (2)

Nasogastric Tube Feeding

ACTIVE COMPARATOR

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.

Device: Nasogastric Tube Feeding

Intermittent Oro-esophageal Tube Feeding

EXPERIMENTAL

the group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding according to the relevant guidelines.

Device: Intermittent Oro-esophageal Tube Feeding

Interventions

Intermittent Oro-esophageal Tube Feeding DEVICE

The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.

Intermittent Oro-esophageal Tube Feeding

Nasogastric Tube Feeding DEVICE

Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.

Nasogastric Tube Feeding

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 CSVD;
• 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.

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

• Copka Sonpashan: lead

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Nieto Luis

  Site Coordinator of United Medical Group

  STUDY CHAIR

Central Study Contacts

Lavie Ce

CONTACT

15333866454; zengxizdyfy@126.com

Study Design

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

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 25, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03