A Randomized Controlled Study to Explore the Clinical Effect of Multifunctional Nutrition Tube Feeding vs. Nasogastric Tube Feeding on Cerebral Small Vessel Disease Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Video Fluoroscopic Swallowing Study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
The control group
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.
Intervention: Nasogastric Tube Feeding (Device)
The control group
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.
Intervention: comprehensive rehabilitation therapy (Behavioral)
The observation group
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.
Intervention: Intermittent Oro-esophageal Tube Feeding (Device)
The observation group
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.
Intervention: comprehensive rehabilitation therapy (Behavioral)
Outcomes
Primary Outcomes
Video Fluoroscopic Swallowing Study
Time Frame: day 1 and day 15
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).
Secondary Outcomes
- Pneumonia(day 1 and day 15)
- Activities of daily living(day 1 and day 15)
- Hemoglobin(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Body mass index(day 1 and day 15)
- World Health Organization Quality of Life Assessment Instrument Brief Version(day 1 and day 15)
- Serum albumin(day 1 and day 15)
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University