A Randomized Controlled Trial to Explore the Effect of Intermittent Oro-esophageal Tube on Feeding Amount
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Copka Sonpashan
- Enrollment
- 80
- Primary Endpoint
- Nutritional status-albumin
- Status
- Not Yet Recruiting
- 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
Copka Sonpashan
The Research Director
Chao Phya Abhaibhubejhr Hospital
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
Nutritional status-albumin
Time Frame: day 1 and day 15
The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.
Nutritional status-prealbumin
Time Frame: day 1 and day 15
The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.
Nutritional status-hemoglobin
Time Frame: day 1 and day 15
The relevant indicators include hemoglobin (Hb, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.
Nutritional status-total protein
Time Frame: day 1 and day 15
The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach ones and in the morning.
Secondary Outcomes
- Body weight(day 1 and day 15)
- Feeding Amount(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)