A Randomized Controlled Trial to Explore the Effect of Intermittent Oro-esophageal Tube vs. Nasogastric Tube on Feeding Amount in Dysphagic Patients After Ischemic Stroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Zeng Changhao
- Locations
- 1
- Primary Endpoint
- Feeding Amount
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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
Investigators
Zeng Changhao
Head of R&D
People's Hospital of Zhengzhou University
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.
Outcomes
Primary Outcomes
Feeding Amount
Time Frame: day 1 and day 15
The total amount of nutrients consumed by the patient on the day was recorded, excluding fresh water, units: milliliters
Secondary Outcomes
- Nutritional status-prealbumin(day 1 and day 15)
- Nutritional status-albumin(day 1 and day 15)
- Body weight(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
- Nutritional status-hemoglobin(day 1 and day 15)
- Nutritional status-total protein(day 1 and day 15)