Intermittent Oro-esophageal Tube Feeding on Cerebral Small Vessel Disease Patients With Dysphagia
Condition: Cerebral Small Vessel Diseases
MeSH terms: Cerebral Small Vessel Diseases
Study type: Interventional

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.
    

Intervention name(s): Nasogastric tube; Intermittent Oro-esophageal Tube
Intervention type(s): Device; Device
Intervention description(s): 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&#39;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&#39;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.; 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.
Other intervention name(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Small Vessel Disease; Enteral Nutrition.; Intermittent Oro-esophageal Tube Feeding