Neurogenic Dysphagia, Tracheotomy Patients
Conditions
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.
Interventions
PROCEDUREintermittent 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.
PROCEDURENaso-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.
Sponsors
Capital Medical University
Zhengzhou Center Hospital
Hunan Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 92 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decannulation time of the tracheostomy tube | From date of randomization until extubation, assessed up to 30 days | Decannulation time of the tracheostomy tube, corresponding to the number of days between entering the decannulation protocol to removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decannulation rate | From date of randomization until extubation, assessed up to 30 days | The rate of successful decannulation among enrolled patients |
| Penetration-Aspiration Scale (PAS) score | up to 30 days | The Penetration-Aspiration Scale (PAS) is a standardized tool for evaluating swallowing safety. It primarily assesses the risk of food or liquid entering the airway (aspiration) or remaining in the larynx (penetration). The scale consists of 8 levels (1-8), with higher scores indicating greater risk and severity of aspiration. It should be used in conjunction with clinical observations (FEES). |
| Nutritional status-albumin(ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI) | up to 30 days | Nutritional status assessed includes albumin (ALB, g/L), prealbumin (PA, mg/L) and body mass index (BMI) at baseline,, 2 weeks after treatment and 1month after treatment. |
| ChSwallowing Quality of Life questionnaire (ChSWAL-QoL) | up to 30 days | ChSWAL-QoL was assessed using the Chinese version of the Swallowing Quality of Life scale\[20\] at baseline,, 2 weeks after treatment and 1month after treatment. |
Countries
China
Outcome results
None listed