Cerebral Small Vessel Diseases Clinical Trial
Official title:
Oral Versus Nasal Enteral Nutrition on Cerebral Small Vessel Disease: A Randomized Controlled Study
Verified date | March 2024 |
Source | Ahmadu Bello University Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 15, 2023 |
Est. primary completion date | June 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Huimin Hos. | Pengfu |
Lead Sponsor | Collaborator |
---|---|
Muhammad |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Body mass index | Weight and height will be combined to report Body mass index in kg/m^2 | day 1 and day 15 | |
Secondary | Serum albumin | Serum albumin was recorded via blood routine test.(Alb, g/L) | day 1 and day 15 | |
Secondary | Hemoglobin | Hemoglobin was recorded via blood routine test.(Hb, mg/L) | day 1 and day 15 | |
Secondary | Pneumonia | The occurrence of pneumonia in patients was assessed before and after treatment. Specifically, first of all, the symptom assessment and physical examination were conducted to all patients, during which, the doctor would inquire symptoms related to pneumonia, such as cough, sputum production, difficulty breathing, chest pain, etc. and observe the patient's respiratory condition, including respiratory rate, breath sounds, and any abnormal signs in the chest. | day 1 and day 15 | |
Secondary | Activities of daily living | The activities of daily living was assessed utilizing the Modified Barthel Index (MBI). Modified Barthel Index includes the following 10 subscales. For each subscale, choices encoded with the score 10, 8, 5, 2, 0 are set with the decreasing level of self-dependence, while the final total is positively correlated with Activities of daily living. Cronbach's a of questionnaire adopted is 0.916. | day 1 and day 15 | |
Secondary | World Health Organization Quality of Life Assessment Instrument Brief Version | The Quality of Life was assessed utilizing the World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF). WHOQOL-BREF covers various aspects such as mobility, pain, emotions, personal relationships, living conditions, and access to health services, to evaluate Quality of Life. Each item is rated on a Likert scale, and the scores are transformed into a standardized score ranging from 0 to 100, with higher scores indicating better Quality of Life. | day 1 and day 15 |
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