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

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Behavioral: Conventional air-pulse stimulation; Behavioral: Modified Air-pulse Stimulation

• Registration Number: NCT06299904
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Conventional air-pulse stimulation	Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.
trial group	Modified Air-pulse Stimulation	The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.

Primary Outcome Measures

Name	Time	Method
the score of penetration-aspiration scale (PAS)	2 weeks	PAS
the score of Murray's secretion scale (MSS)	2 weeks	MSS
the score of Fiberoptic endoscopic examination of swallowing (FEES)	2 weeks	Fiberoptic endoscopic examination of swallowing

Secondary Outcome Measures

Name	Time	Method
the score of Clinical Pulmonary Infection Score (CPIS)	2 weeks	CPIS

Trial Locations

Locations (1)

the Second Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China