Clinical trial NCT06206122: Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease
Official title: A Randomized Trial to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.

Primary outcomes:
measure: Video Fluoroscopic Swallowing Study
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 15
measure: Serum albumin
timeFrame: day 1 and day 15
measure: Hemoglobin
timeFrame: day 1 and day 15
measure: Modified Barthel Index
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng da yi fu yuan hospital
Study officials:
affiliation: Zhengzhou Tielu Hospital
name: Sumei Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: