NCT06299904

Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: The Second Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.

Conditions

• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Modified Air-pulse Stimulation	Connected the oxygen humidification bottle to a fibreoptic endoscope, then inserted the terminal into the nasal cavity and the pulse sensation stimulation generated by oxygen was transmitted through the internal port of the fibreoptic endoscope to the anterior wall of the pyriform recess or to the folds of the arytenoepiglottis. (5 min once a day for 2 weeks)
BEHAVIORAL	Conventional air-pulse stimulation	The terminal airway of the air pulse was placed in the oral cavity, specifically in the patient's palatoglossal arch, pharyngeal posterior wall, tongue base, and other areas. The airbag was quickly squeezed to generate airflow and stimulate the mucosa.(5 min once a day for 2 weeks)

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: China