Intermittent Oral Tube on Feeding Amount

NCT ID: NCT06328933

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-12-31

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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent Oro-esophageal Tube Feeding+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

Group Type: EXPERIMENTAL

Intermittent Oro-esophageal Tube Feeding

Intervention Type: DEVICE

The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

comprehensive rehabilitation therapy

Intervention Type: BEHAVIORAL

Including： 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.

Nasogastric Tube Feeding+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.

Group Type: ACTIVE_COMPARATOR

Nasogastric Tube Feeding

Intervention Type: DEVICE

The control group was given enteral nutritional support with Nasogastric Tube Feeding 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 patient\'s 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. The feeding content was formulated by the nutritionists based on the patients 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. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

comprehensive rehabilitation therapy

Intervention Type: BEHAVIORAL

Including： 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.

Interventions

Nasogastric Tube Feeding

The control group was given enteral nutritional support with Nasogastric Tube Feeding 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 patient\'s 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. The feeding content was formulated by the nutritionists based on the patients 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. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

Intervention Type: DEVICE

Intermittent Oro-esophageal Tube Feeding

The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

Intervention Type: DEVICE

comprehensive rehabilitation therapy

Including： 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copka Sonpashan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Copka Sonpashan

The Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nieto Li

Role: STUDY_CHAIR

Site Coordinator of United Medical Group located in Miami

Central Contacts

Lavie Ce

Role: CONTACT

linchuangzhuce@163.com

15333828388

Other Identifiers

IOE feeding amount

Identifier Type: -

Identifier Source: org_study_id