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

ConditionsNeurogenic DysphagiaTracheotomy Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-92
SponsorCapital Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • intermittent oro-esophageal

    Procedure/Surgery

    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.

  • Naso-intestinal tube nutrition support

    Procedure/Surgery

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Control groupExperimental treatment 1 intervention
Group B: experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Decannulation time of the tracheostomy tube

Time frame
6 month

Secondary outcomes

1

Decannulation rate

Time frame
6 month
2

Flexible endoscopic examination of swallowing

Time frame
6 month
3

Nutritional status-albumin

Time frame
6 month
4

Swallowing Quality of Life questionnaire

Time frame
6 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: