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

March 1, 2024 updated by: The Second Affiliated Hospital of Dalian Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116024
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: control group
Based on receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy.
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)
Experimental: trial group
The trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of Fiberoptic endoscopic examination of swallowing (FEES)
Time Frame: 2 weeks
Fiberoptic endoscopic examination of swallowing
2 weeks
the score of Murray's secretion scale (MSS)
Time Frame: 2 weeks
MSS
2 weeks
the score of penetration-aspiration scale (PAS)
Time Frame: 2 weeks
PAS
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of Clinical Pulmonary Infection Score (CPIS)
Time Frame: 2 weeks
CPIS
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STROkE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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