A Randomized Controlled Study to Explore the Clinical The Effect of Oral and Nasal Feeding on Cerebral Small Vessel Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 70
Healthy Volunteers: f
View:

• Clinical diagnosis of Cerebral Small Vessel Disease;

• 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.

Locations
Other Locations
Thailand
Ratchaburi Center Hos.
RECRUITING
Ratchaburi
Contact Information
Primary
Zhefeng Wang, Master
zhengzhouzhj@qq.com
19501376864
Backup
Weijia Zhao, Master
zwjww2009@163.com
17839973473
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2024-05
Participants
Target number of participants: 88
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Zeng Changhao

This content was sourced from clinicaltrials.gov