Stroke Clinical Trial
Official title:
A Randomized Controlled Trial to Explore the Effect of Intermittent Oro-esophageal Tube on Feeding Amount
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
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Copka Sonpashan |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Nutritional status-total protein | 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. | day 1 and day 15 | |
Primary | Nutritional status-hemoglobin | 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. | day 1 and day 15 | |
Primary | Nutritional status-albumin | 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. | day 1 and day 15 | |
Primary | Nutritional status-prealbumin | 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. | day 1 and day 15 | |
Secondary | Feeding Amount | The total amount of nutrients consumed by the patient on the day was recorded, excluding fresh water, units: milliliters | day 1 and day 15 | |
Secondary | Body weight | Body weight measurement of the infants was conducted by the same nurse according to the relevant standards. | day 1 and day 15 | |
Secondary | Functional Oral Intake Scale | During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted. | day 1 and day 15 |
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