A Randomized Controlled Trial to Explore the Effect of Intermittent Oro-esophageal Tube on Feeding Amount
| Registry | NCT06328933 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Copka Sonpashan (Other gov) |
| Conditions | Stroke |
| Interventions | Nasogastric Tube Feeding, Intermittent Oro-esophageal Tube Feeding, comprehensive rehabilitation therapy (Device, behavioral) |
| Dates | start 2024-03-01 (estimated), primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2024-03-25, last updated 2024-03-25 |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials of Nasogastric Tube Feeding All trials of Intermittent Oro-esophageal Tube Feeding
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
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intermittent Oro-esophageal Tube Feeding+comprehensive rehabilitation therapy | Experimental | Device: Intermittent Oro-esophageal Tube Feeding; Behavioral: comprehensive rehabilitation therapy | 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 |
| Nasogastric Tube Feeding+comprehensive rehabilitation therapy | Active comparator | Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy | 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. |
Sex: All, ages: 18 Years to any
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.