Improving swallowing in stroke patients with tracheostomy using modified air-pulse stimulation
Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
This study is testing a new way to help stroke patients with tracheostomy swallow better by using a special air-pulse technique to see if it works better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | The Second Affiliated Hospital of Dalian Medical University Academic / other |
| Locations | 1 site (Dalian, Liaoning) |
| Trial ID | NCT06299904 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of modified air-pulse stimulation mediated by flexible endoscopy in restoring swallowing function in subacute stroke patients who have undergone tracheotomy and experience dysphagia. A total of 42 patients will be recruited and divided into two groups: one receiving traditional air-pulse stimulation and the other receiving the modified version. The study will assess dysphagia using various scales, including the Murray secretion scale and penetration-aspiration scale, while also monitoring nutritional status and pneumonia risk. The goal is to determine if the modified approach leads to better outcomes in swallowing rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are subacute stroke patients aged 30 to 80 years with tracheotomy and dysphagia who have stable vital signs.
Not a fit: Patients with severe complications such as medullary hemorrhage, unstable arrhythmia, or those unable to cooperate with treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve swallowing function and quality of life for patients with dysphagia after stroke.
How similar studies have performed: While similar approaches have been explored, this specific modified air-pulse stimulation technique is novel and has not been extensively tested in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease; * patients with relatively stable vital signs, with a NIHSS score of 21 points; * patients with tracheotomy accompanied by dysphagia; * no previous history of dysphagia; * age ≥ 30 years and ≤80 years; * informed consent signed by the patient and his family. Exclusion Criteria: * patients with medullary haemorrhage/infarction; * patients that experienced cerebral hernia and recurrent stroke; * patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment; * patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour; * patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease; * patients with a history of epilepsy or risk of seizures.
Where this trial is running
Dalian, Liaoning
- the Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.