Clinical trial NCT06637098: The Impact of Gastrostomy and Intermittent Oral Tube Feeding on Patients With Dysphagia and Bulbar Palsy After Stroke
Official title: The Impact of Gastrostomy and Intermittent Oral Tube Feeding on Patients With Dysphagia and Bulbar Palsy After Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Buraidah Central Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Dysphagia Handicap Index
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
References: