NCT06206122

Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease

A Randomized Trial to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zeng Changhao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are: • Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding. Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Detailed description

Nasogastric tube feeding has been widely used in patients with Parkinson's disease but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are: • Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding. Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Nasogastric tube	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 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 patient's 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.
DEVICE	Intermittent Oro-esophageal Tube	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.
BEHAVIORAL	Comprehensive rehabilitation training	1. Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. 2. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. 3. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.

Timeline

• Start date: 2024-01-05
• Primary completion: 2024-04-01
• Completion: 2024-04-05
• First posted: 2024-01-16
• Last updated: 2024-03-05

Locations

1 site across 1 country: China