Clinical trial NCT06791590: Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia
Official title: Evaluating the Effects of Intermittent Oro-esophageal in Tracheotomy Patients With Neurogenic Dysphagia: a Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurogenic Dysphagia
Tracheotomy Patients
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Decannulation time of the tracheostomy tube
timeFrame: 6 month
Secondary outcomes:
measure: Decannulation rate
timeFrame: 6 month
measure: Flexible endoscopic examination of swallowing
timeFrame: 6 month
measure: Nutritional status-albumin
timeFrame: 6 month
measure: Swallowing Quality of Life questionnaire
timeFrame: 6 month
measure: leakage-aspiration grade
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
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