The Impact of Gastrostomy and Intermittent Oral Tube Feeding on Patients With Dysphagia and Bulbar Palsy After Stroke

Sponsor
Babujinaya Cela
Study ID
NCT06637098
Status
Not Yet Recruiting

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Conditions

  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • routine rehabilitation therapy — BEHAVIORAL
    Including： Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
  • Oral tube feeding — BEHAVIORAL
    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. 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.
  • Gastrostomy feeding — BEHAVIORAL
    Feeding begins through the gastrostomy tube. A registered dietitian will develop a tailored feeding plan, specifying the type and amount of nutrition. Healthcare providers regularly monitor the patient's tolerance to feeding, checking for any signs of complications. Adjustments to the feeding regimen may be made based on the patient's progress and nutritional needs.

Study Details

The goal of this clinical trial is to compare the differences in quality of life and nutritional status between ischemic stroke patients With Dysphagia and Bulbar Palsy using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

Key Dates

First listed
Oct 15, 2024
Start date
Nov 30, 2024
Status verified
Oct 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral tube group+routine rehabilitation therapy
    Assigned randomly before the treatment, all patients were provided with routine rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. The oral tube group will be given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the 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
  • Active Comparator: Gastrostomy group+routine rehabilitation therapy
    Assigned randomly before the treatment, all patients were provided with routine rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. The Gastrostomy group will be given enteral nutritional support with Gastrostomy. The feeding content was formulated by the nutritionists based on the 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

Primary Outcome Measure

Body weight [ Time Frame: day 1 and day 15 ]

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