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NCT Number: NCT06637098

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

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Body weight

    Time frame: day 1 and day 15

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

Secondary outcomes

  1. Dysphagia Handicap Index

    Time frame: day 1 and day 15

    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

Sponsors and collaborators

Lead sponsor

Babujinaya Cela

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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