Effect of Intermittent Oro-esophageal Tube vs. Nasogastric Tube on Feeding Amount in Stroke Patients

Z

Zeng Changhao

Status

Withdrawn

Conditions

Ischemic Stroke

Treatments

Device: Intermittent Oro-esophageal Tube Feeding
Behavioral: comprehensive rehabilitation therapy
Device: Nasogastric Tube Feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT06202807
2024-KY-0102

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

the observation group
Experimental group
Description:
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups
Treatment:
Behavioral: comprehensive rehabilitation therapy
Device: Intermittent Oro-esophageal Tube Feeding
the control group
Active Comparator group
Description:
Assigned randomly before the treatment, all patients were provided with comprehensive rehabilitation therapy as follows: Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training. Besides, the control group was given enteral nutritional support with Nasogastric Tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.
Treatment:
Device: Nasogastric Tube Feeding
Behavioral: comprehensive rehabilitation therapy

Trial contacts and locations

1

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Central trial contact

Zhefeng Wang, Doctor; Weiji Zhao, Master

Data sourced from clinicaltrials.gov

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