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

NCT06637098 | Not Yet Recruiting

• 1 other identifier: PGE VS IOE
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.

  day 1 and day 15

Secondary Outcomes (1)

• Dysphagia Handicap Index

  day 1 and day 15

Study Arms (2)

Oral tube group+routine rehabilitation therapy

EXPERIMENTAL

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

Behavioral: routine rehabilitation therapy; Behavioral: Oral tube feeding

Gastrostomy group+routine rehabilitation therapy

ACTIVE COMPARATOR

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

Behavioral: routine rehabilitation therapy; Behavioral: Gastrostomy feeding

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.

Gastrostomy group+routine rehabilitation therapy; Oral tube group+routine rehabilitation therapy

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.

Oral tube group+routine rehabilitation therapy

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.

Gastrostomy group+routine rehabilitation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years.
• Meeting the diagnostic criteria for ischemic stroke .
• Dysphagia confirmed by Videofluoroscopic Swallowing Study.
• Clear consciousness.
• No history of prior stroke.
• Stable vital signs.

You may not qualify if:

• Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
• Pregnant or nursing females.

Sponsors & Collaborators

• Babujinaya Cela: lead

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Research Director

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10