Intermittent Oro-esophageal Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia

NCT06179550 | Terminated DMC

• 2 other identifiers: 2022-KY-1532Zhengzhou University
• 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

Keywords

Cerebral Small Vessel Disease; Enteral Nutrition.; Intermittent Oro-esophageal Tube Feeding

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 (7)

• Functional Oral Intake Scale

  day 1 and day 15

• 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

Study Arms (2)

The control group

ACTIVE COMPARATOR

Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. Besides, the control group was given enteral nutritional support with NGT 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 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.

Device: Nasogastric tube

The observation group

EXPERIMENTAL

Assigned by the random number table.During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: 1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. The observation group was given enteral nutritional support with IOE according to the following procedure. The feeding content was formulated by the nutritionists based on the patient\'s 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

Device: Intermittent Oro-esophageal Tube

Interventions

Nasogastric tube DEVICE

Besides, the control group was given enteral nutritional support with NGT 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 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 patient\'s 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.

Also known as: 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles., 2) Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training., 3) Pulmonary function training, including standing training, cough training, and diaphragm muscle training.

The control group

Intermittent Oro-esophageal Tube DEVICE

The observation 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 (Appendix). 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.

Also known as: 1) Basic treatment, including corresponding control of risk factors and education on healthy lifestyles., 2) Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training., 3) Pulmonary function training, including standing training, cough training, and diaphragm muscle training.

The observation group

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, 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.

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;
• Unable or unwilling to undergo VFSS;
• Pregnant or nursing females.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

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 located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researchers respectively responsible for intervention, assessment, and data collection maintained an isolated status from the patients enrolled beyond the necessary contact, strictly adhering to the principle of not disclosing group information. Furthermore, the trained professionals who were not involved in the intervention were selected to conduct all assessments, data collection, and analysis to ensure the objectivity and independence of result evaluation. All medical personnel involved in interventions received detailed training to ensure their understanding and proper implementation of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2023
• Primary Completion: June 3, 2023
• Study Completion: June 22, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)