TerminatedNot Applicable

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

Stopped: ethical issues

China60 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range40 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Video Fluoroscopic Swallowing Study

Timeframe: day 1 and day 15

Trial details

NCT IDNCT06179550

SponsorZeng Changhao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-03