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Clinical Trials/NCT06301607
NCT06301607
Not yet recruiting
Not Applicable

The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients: A Randomized Controlled Trial

Muhammad0 sites80 target enrollmentMarch 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Muhammad
Enrollment
80
Primary Endpoint
Feeding Amount
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

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muhammad
Responsible Party
Sponsor Investigator
Principal Investigator

Muhammad

Research Director

Ahmadu Bello University Teaching 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

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

  • Body weight(day 1 and day 15)
  • total protein level(day 1 and day 15)
  • hemoglobin level(day 1 and day 15)
  • albumin level(day 1 and day 15)
  • prealbumin level(day 1 and day 15)
  • Functional Oral Intake Scale(day 1 and day 15)

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