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

NCT ID: NCT06299904

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.

Group Type: SHAM_COMPARATOR

Conventional air-pulse stimulation

Intervention Type: BEHAVIORAL

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)

trial group

The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.

Group Type: EXPERIMENTAL

Modified Air-pulse Stimulation

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status: RECRUITING

Countries

China

Facility Contacts

wuyao Pan, postgraduate

Role: primary

331189506@qq.com

+86-18186766836

Other Identifiers

stroke

Identifier Type: -

Identifier Source: org_study_id