Clinical trial NCT06301607: The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients
Official title: The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
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 feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

Detailed description: The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

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: Feeding Amount
timeFrame: day 1 and day 15
Secondary outcomes:
measure: total protein level
timeFrame: day 1 and day 15
measure: hemoglobin level
timeFrame: day 1 and day 15
measure: albumin level
timeFrame: day 1 and day 15
measure: prealbumin level
timeFrame: day 1 and day 15
measure: Body weight
timeFrame: day 1 and day 15
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: