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

The Impact of Gastrostomy and Intermittent Oral Tube Feeding on Patients With Dysphagia and Bulbar Palsy After Stroke: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Behavioral: routine rehabilitation therapy; Behavioral: Oral tube feeding; Behavioral: Gastrostomy feeding

Detailed Description

This study lasts 15 days for each patient. 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: routine rehabilitation therapy; 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.; Behavioral: Oral tube feeding; 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.
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	Behavioral: routine rehabilitation therapy; 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.; Behavioral: Gastrostomy feeding; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia Handicap Index	The Dysphagia Handicap Index is a 25-item scale to evaluate swallowing-related quality of life. The scale scores range between 0 to 100 and a higher score indicate better quality of life	day 1 and day 15

Collaborators and Investigators

• Sponsor: Babujinaya Cela

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Neuromuscular Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neurodegenerative Diseases; Esophageal Diseases; Motor Neuron Disease; Deglutition Disorders; Bulbar Palsy, Progressive
• Other Study ID Numbers: PGE VS IOE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No