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

Capital Medical University

Status: Not yet enrolling

Conditions: Neurogenic Dysphagia; Tracheotomy Patients

Treatments: Procedure: intermittent oro-esophageal; Procedure: Naso-intestinal tube nutrition support

Study type: Interventional

Funder types: Other

Identifiers

NCT06791590

2025bkky-003

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 92 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

Control group

Experimental group

Description:

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.

Treatment:

Procedure: Naso-intestinal tube nutrition support

experimental group

Experimental group

Description:

Disposable gastric tube was used for enteral nutrition support

Treatment:

Procedure: intermittent oro-esophageal