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NCT Number: NCT06818513

Effects of Gastrostomy and Oral Tube Feeding on Patients With Dysphagia After Stroke

The goal of this clinical trial is to compare the differences in swallowing function, quality of life and nutritional status between ischemic stroke patients with dysphagia 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 swallowing function, 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

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study will last 15 days for each patient. The goal of this clinical trial is to compare the differences in swallowing function, quality of life and nutritional status between ischemic stroke patients with dysphagia 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 swallowing function, 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

  • Use of tracheostomy tubes.
  • 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.

Gastrostomy

Dietary Supplement

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.

Oral tube feeding

Dietary Supplement

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. 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.

Primary outcomes

  1. Body mass index

    Time frame: day 1 and day 15

    body mass index will be calculated as body weight/height^2.

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 poorer quality of life

  2. Penetration-Aspiration Scale

    Time frame: day 1 and day 15

    The Penetration-Aspiration Scale was used to evaluate airway protection. The score could range between 0 and 8, with higher scores indicating poor swallowing safety.

  3. Modified Barium Swallow Impairment Profile

    Time frame: day 1 and day 15

    The Modified Barium Swallow Impairment Profile was conducted by an independent and registered speech-language pathologist. The scale includes 17 items to cover oral, pharyngeal, and esophageal phases of swallowing. The total score ranges from 0 to 55, with higher scores indicating poorer swallowing function.

Sponsors and collaborators

Lead sponsor

Muhammad

Other

Registry information

Official study title

Effects of Gastrostomy and Intermittent Oral Tube Feeding on Patients With Dysphagia After Stroke

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

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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