Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia

Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia: a Randomized Study

Neurogenic dysphagia refers to swallowing disorders caused by the damage of swallowing central or peripheral nerves and muscles. According to statistics, about 50% of patients with neurological diseases will be complicated with neurogenic dysphagia. Common diseases include stroke, dementia, Parkinson's disease and neuromuscular diseases. Dysphagia has a great impact on the quality of life of patients, and is related to malnutrition, aspiration pneumonia and even death. In severe cases, tracheotomy is required to maintain airway patency and discharge secretions. The common nutritional support methods for patients with neurogenic dysphagia after tracheotomy are nasogastric or nasointestinal tube placement and percutaneous gastrostomy.

intermittent oro-esophageal tube feeding (IOE) is a new nutrition method proposed by scholars in recent years. Studies have shown that it can improve the swallowing function of patients with dysphagia while meeting the nutritional needs of patients, so as to effectively improve the quality of life of patients. However, there are few studies on patients with dysphagia after tracheotomy. This study aims to compare the intervention effects of two kinds of tube feeding methods in patients with neurogenic dysphagia after tracheotomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurogenic Dysphagia; Tracheotomy Patients
• Intervention / Treatment: Procedure: Naso-intestinal tube nutrition support; Procedure: intermittent oro-esophageal

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of neurogenic dysphagia；
• Acute phase has passed, weaning time > 48 hours, tracheotomy time >1 week; in accordance with the decannulation process of tracheotomy patients formulated by our center in 2018;
• steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment；
• Gastrointestinal motility is good, can tolerate more than 150ml/h feeding pump speed;
• Willing to sign an informed consent form.

Exclusion Criteria:

• Structural swallowing disorders, such as oral, pharyngeal, larynx, esophagus and other anatomical abnormalities caused by swallowing disorders;
• The clinical condition was unstable, accompanied by heart, lung, brain and other important organ dysfunction;
• Severe cognitive dysfunction, confusion, unable to cooperate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Intranasal continuous nasogastric tube or nasogastric tube nutritional support was used. For patients at risk of repeated aspiration and regurgitation, patients with gastric nutritional intolerance who could not be improved by using gastrointestinal motility drugs, intestinal indentation tube and retropyloric feeding were given.	Procedure: Naso-intestinal tube nutrition support; For patients at risk of repeated aspiration and regurgitation, and for patients with gastric nutritional intolerance that cannot be improved by gastrointestinal motivity drugs, indwelling intestinal tube and retropyloric feeding are given.
Experimental: experimental group; Disposable gastric tube was used for enteral nutrition support	Procedure: intermittent oro-esophageal; A disposable gastric tube was used to perform enteral nutrition support therapy, and contraindications were evaluated again. Inform the patient and family members of the precautions for intermittent feeding through oral tube, and play the video of the operation process to make them actively cooperate with the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decannulation time of the tracheostomy tube	6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Decannulation rate	6 month
Flexible endoscopic examination of swallowing	6 month
Nutritional status-albumin	6 month
Swallowing Quality of Life questionnaire	6 month
leakage-aspiration grade	6 month

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 28, 2025
• Primary Completion (Estimated): February 10, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2025bkky-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No