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

NCT ID: NCT06791590

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2025-12-30

Brief Summary

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.

Conditions

Neurogenic Dysphagia; Tracheotomy Patients

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Naso-intestinal tube nutrition support

Intervention Type: PROCEDURE

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 group

Disposable gastric tube was used for enteral nutrition support

Group Type: EXPERIMENTAL

intermittent oro-esophageal

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 92 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jingyi Ge

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025bkky-003

Identifier Type: -

Identifier Source: org_study_id